<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02197130</url>
  </required_header>
  <id_info>
    <org_study_id>A8241021</org_study_id>
    <secondary_id>2014-001291-56</secondary_id>
    <nct_id>NCT02197130</nct_id>
  </id_info>
  <brief_title>Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease</brief_title>
  <official_title>A Phase 2, Randomized, Placebo Controlled, Double Blind Proof-of-concept Study Of The Efficacy And Safety Of Pf-02545920 In Subjects With Huntington's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a 26 week, randomized, parallel group, double blind comparison of PF-02545920 5&#xD;
      mg, PF-02545920 20 mg, and placebo dosed BID in the treatment of motor impairment of subjects&#xD;
      with Huntington's Disease. A total of approximately 260 subjects are planned to be randomized&#xD;
      in the study. Primary endpoint is the change from baseline in the Total Motor Score (TMS)&#xD;
      assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 26 weeks of&#xD;
      treatment. secondary endpoints will include change from baseline in the Total Maximum Chorea&#xD;
      (TMC) score of the UHDRS after 13 and 26 weeks of treatment and Clinical Global&#xD;
      Impression-Improvement score after 13 and 26 weeks of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment.</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of Huntington's Disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The total motor score (TMS) assessed motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. Some items (such as chorea and dystonia) required grading each extremity (face, bucco-oral-lingual, and trunk) separately. Eye movements require both horizontal and vertical grades. The total motor impairment scores was the sum of all the individual 31 motor sub-items (each rated from 0 to 4), with higher scores indicating more severe motor impairment than lower scores. The range of TMS is 0-124.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria</measure>
    <time_frame>Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
    <description>The criteria for temporary study suspension was as follow: Criterion A: WBC count &lt;=3000 cells/mm3 but &gt;= 2000 cells/mm3 or ANC &lt;= 1500 cells/mm3 but &gt;= 1000 cells/mm3; Criterion B: WBC &lt;= 2000 cells/mm3 or ANC &lt;= 1000 cells/mm3; Criterion C: participants who are discontinued or permanently suspended due to WBC or ANC findings; Criterion D: ANC &lt;= 500 cells/mm3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
    <description>Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events</measure>
    <time_frame>Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
    <description>Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormalities)</measure>
    <time_frame>Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
    <description>Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], urine specific gravity, glucose, protein, blood, ketones, nitrite).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Laboratory Test Abnormalities (With Normal Baseline)</measure>
    <time_frame>Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
    <description>Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], urine specific gravity, glucose, protein, blood, ketones, nitrite).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Absolute Values)</measure>
    <time_frame>Screening, Day 1, 28, 91, and 182</time_frame>
    <description>Absolute values were analyzed for supine systolic blood pressure (SBP), standing SBP, supine diastolic blood pressure (DBP), standing DBP, supine pulse rate, and standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: Criterion A: supine SBP less than (&lt;) 90 millimeter of mercury(mmHg); Criterion B: standing SBP &lt; 90 mmHg; Criterion C: supine DBP &lt;50 mmHg; Criterion D: standing DBP &lt;50 mmHg; Criterion E: supine pulse rate &lt; 40 beats per minute(BPM); Criterion F: supine pulse rate greater than (&gt;)120 BPM; Criterion G: standing pulse rate &lt; 40 beats per minute(BPM); Criterion H: standing pulse rate &gt;120 BPM;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Increase From Baseline)</measure>
    <time_frame>Screening, Day 1, 28, 91, and 182</time_frame>
    <description>The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine SBP greater than or equal to (&gt;=) 30 mmHg; Criterion B: maximum increase from baseline in standing SBP &gt;= 30 mmHg; Criterion C: maximum increase from baseline in supine DBP &gt;=20 mmHg; Criterion D: maximum increase from baseline in standing DBP &gt;=20 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Decrease From Baseline)</measure>
    <time_frame>Screening, Day 1, 28, 91, and 182</time_frame>
    <description>The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine SBP &gt;= 30 mmHg; Criterion B: maximum decrease from baseline in standing SBP &gt;= 30 mmHg; Criterion C: maximum decrease from baseline in supine DBP &gt;=20 mmHg; Criterion D: maximum decrease from baseline in standing DBP &gt;=20 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Absolute Values)</measure>
    <time_frame>Screening, Day 1, 28, 91, and 182</time_frame>
    <description>The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) &gt;=300 msec; Criterion B: maximum QRS complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) &gt;=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula) 450-&lt;480 msec; Criterion D: maximum QTcF interval 480-&lt;500 msec; Criterion E: maximum QTcF interval (Fridericia's correction) &gt;=500 msec</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Increase From Baseline)</measure>
    <time_frame>Screening, Day 1, 28, 91, and 182</time_frame>
    <description>Number of participants with ECG meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)&gt;= 25/50%; Criterion B: maximum QRS complex increase from baseline PctChg &gt;=50%; Criterion C: maximum QTcF interval (Fridericia's correction) increase from baseline 30&lt;=change&lt;60 msec; Criterion D: maximum QTcF interval (Fridericia's correction) increase from baseline change &gt;=60 msec.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Adverse Events Related to Extrapyramidal Symptoms (EPS) Including Dystonia and Akathisia</measure>
    <time_frame>Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
    <description>Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event). EPS were reported AEs of dystonia and akathisia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Total Maximum Chorea (TMC) Score of the UHDRS After 13 and 26 Weeks of Treatment.</measure>
    <time_frame>Baseline, Week 13, Week 26</time_frame>
    <description>The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The Total Maximum Chorea (TMC) was a subset of the TMS assessment. It was composed of the scoring of 7 chorea assessments (face, orobuccolingual, trunk, right and left upper extremities, right and left lower extremities). Each assessment was rated from 0 to 4 (absent to prolonged). TMC is obtained by adding up each of the separate scores, leading to max score of 28. The minimum score is 0. The higher the score, the worse the symptoms. n is the number of evaluable subjects in each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Follow-up Visit</measure>
    <time_frame>Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
    <description>The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression of Improvement (CGI-I) Scale Score After 13 and 26 Weeks of Treatment.</measure>
    <time_frame>Week 13 &amp; Week 26</time_frame>
    <description>CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: &quot;Compared to your subject's condition at the beginning of treatment, how much has your subject changed?&quot;. Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. n is the number of evaluable participants in each visit.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">272</enrollment>
  <condition>Huntington's Disease</condition>
  <arm_group>
    <arm_group_label>20 mg PF-02545920 BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 mg PF-02545920 BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 mg PF-02545920 BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mg PF-02545920 BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo BID</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-02545920</intervention_name>
    <description>20 mg twice a day (BID) for 26 weeks. Each 20 mg dose will be taken as 4 tablets of 5 mg. The 20mg dose will be titrated as follow: 5mg BID for 7 days, 10mg BID for 7 days, 15 mg BID for 7 days and 20 mg BID to week 26. Study drug will be provided in weekly blister cards.</description>
    <arm_group_label>20 mg PF-02545920 BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-02545920</intervention_name>
    <description>5 mg twice a day (BID) for 26 weeks. Each 5 mg dose will be taken as 4 tablets: one tablet of 5 mg and 3 tablets of matching placebo. The 5mg dose will not be titrated. Study drug will be provided in weekly blister cards.</description>
    <arm_group_label>5 mg PF-02545920 BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching Placebo twice a day (BID) for 26 weeks. Each placebo dose will be taken as 4 tablets of matching Placebo. The placebo dose will not be titrated. Matching placebo will be provided in weekly blister cards.</description>
    <arm_group_label>Placebo BID</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CAG repeat equal or greater than 36;&#xD;
&#xD;
          -  Total motor score equal or greater than 10;&#xD;
&#xD;
          -  Total functional capacity equal or greater than 7.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant neurologic disorder other than Huntington's disease;&#xD;
&#xD;
          -  Other severe acute psychiatric conditions, mania and/or psychosis;&#xD;
&#xD;
          -  History of neutropenia, and myeloproliferative disorders;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Kirklin Clinic of UAB Hospital</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ronald Regan UCLA Medical Center Drug Information Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Neurology Clinic</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Radiology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Movement Disorders Center</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Center for Movement Disorders and Neurorestoration</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Health Neuroscience Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Charlestown</city>
        <state>Massachusetts</state>
        <zip>02129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical College</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center - Dept. of Neurology</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation Hospital Pharmacy</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Davis Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Wexner Medical Center at the Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wexner Medical Center at the Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Centre for Huntington Disease</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 2B5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre for Movement Disorders</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M3B 2S7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUM-Notre-Dame Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUM Notre Dame, Pharmacie</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4L 4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Technische Universität München</name>
      <address>
        <city>Munchen</city>
        <state>Bavaria</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinik RWTH Aachen</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Universitatsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prof. Dr. Carsten Saft</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Friedrich-Alexander-Universität</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prof. Dr. med. Stephan Klebe</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitat zu Lubeck</name>
      <address>
        <city>Lubeck</city>
        <zip>23562</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philipps Universitat Marburg</name>
      <address>
        <city>Marburg</city>
        <zip>35043</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Huntington Institut</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kbo-Isar-Amper-Klinikum gGmbH</name>
      <address>
        <city>Taufkirchen</city>
        <zip>84416</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Wuerzburg</name>
      <address>
        <city>Wuerzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Copernicus Podmiot Leczniczy sp. z o.o.</name>
      <address>
        <city>Gdansk</city>
        <zip>80462</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krakowska Akademia Neurologii Sp. z o.o.</name>
      <address>
        <city>Krakow</city>
        <zip>31505</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Solumed Centrum Medyczne</name>
      <address>
        <city>Poznan</city>
        <zip>60529</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut Psychiatrii i Neurologii</name>
      <address>
        <city>Warszawa</city>
        <zip>02957</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Grampian, Clinical Genetics Centre</name>
      <address>
        <city>Aberdeen</city>
        <state>Aberdeenshire</state>
        <zip>AB25 2ZA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton NHS Foundation Trust</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Trust</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham &amp; Solihull Mental Health NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2FG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Van Geest Centre for Brain Repair</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0PY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wales Hospital</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Greater Glasgow and Clyde</name>
      <address>
        <city>Glasgow</city>
        <zip>G51 4TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Facility</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals Huntington's Disease Research Centre</name>
      <address>
        <city>London</city>
        <zip>WC1B 5EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>WC1N 3BG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Manchester University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The National Institute for Health Research/Wellcome Trust Clinical Research Facility</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Nicholas Hospital</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE3 3XT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle Magnetic Resonance Centre</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE4 5PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Germany</country>
    <country>Poland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8241021</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <results_first_submitted>September 7, 2017</results_first_submitted>
  <results_first_submitted_qc>October 13, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 17, 2017</results_first_posted>
  <last_update_submitted>October 13, 2017</last_update_submitted>
  <last_update_submitted_qc>October 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Huntington; chorea; total motor score; CAG repeat: total functional capacity; motor cognitive and behavioral symptoms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Huntington Disease</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 272 subjects (133 males and 139 females) were randomized and assigned study treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PF-02545920 5 mg BID</title>
          <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
        </group>
        <group group_id="P3">
          <title>PF-02545920 20 mg BID</title>
          <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
                <participants group_id="P2" count="89"/>
                <participants group_id="P3" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
                <participants group_id="P2" count="88"/>
                <participants group_id="P3" count="87"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="81"/>
                <participants group_id="P3" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="32"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="23"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Does not meet entrance criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PF-02545920 5 mg BID</title>
          <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
        </group>
        <group group_id="B3">
          <title>PF-02545920 20 mg BID</title>
          <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="95"/>
            <count group_id="B2" value="88"/>
            <count group_id="B3" value="87"/>
            <count group_id="B4" value="270"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.3" spread="8.6"/>
                    <measurement group_id="B2" value="50.2" spread="9.4"/>
                    <measurement group_id="B3" value="48.4" spread="9.2"/>
                    <measurement group_id="B4" value="48.9" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="139"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment.</title>
        <description>The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of Huntington's Disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The total motor score (TMS) assessed motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. Some items (such as chorea and dystonia) required grading each extremity (face, bucco-oral-lingual, and trunk) separately. Eye movements require both horizontal and vertical grades. The total motor impairment scores was the sum of all the individual 31 motor sub-items (each rated from 0 to 4), with higher scores indicating more severe motor impairment than lower scores. The range of TMS is 0-124.</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements did not contribute to the analysis, except in the description of the baseline values.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment.</title>
          <description>The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of Huntington's Disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The total motor score (TMS) assessed motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. Some items (such as chorea and dystonia) required grading each extremity (face, bucco-oral-lingual, and trunk) separately. Eye movements require both horizontal and vertical grades. The total motor impairment scores was the sum of all the individual 31 motor sub-items (each rated from 0 to 4), with higher scores indicating more severe motor impairment than lower scores. The range of TMS is 0-124.</description>
          <population>All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements did not contribute to the analysis, except in the description of the baseline values.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="8.63"/>
                    <measurement group_id="O2" value="-0.8" spread="7.30"/>
                    <measurement group_id="O3" value="-1.4" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2033</p_value>
            <method>MMRM</method>
            <method_desc>MMRM: A linear mixed-effect repeated measures model</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.52</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.192</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.45</ci_lower_limit>
            <ci_upper_limit>3.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7549</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.35</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.118</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.20</ci_lower_limit>
            <ci_upper_limit>1.50</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria</title>
        <description>The criteria for temporary study suspension was as follow: Criterion A: WBC count &lt;=3000 cells/mm3 but &gt;= 2000 cells/mm3 or ANC &lt;= 1500 cells/mm3 but &gt;= 1000 cells/mm3; Criterion B: WBC &lt;= 2000 cells/mm3 or ANC &lt;= 1000 cells/mm3; Criterion C: participants who are discontinued or permanently suspended due to WBC or ANC findings; Criterion D: ANC &lt;= 500 cells/mm3</description>
        <time_frame>Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
        <population>All participants with at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria</title>
          <description>The criteria for temporary study suspension was as follow: Criterion A: WBC count &lt;=3000 cells/mm3 but &gt;= 2000 cells/mm3 or ANC &lt;= 1500 cells/mm3 but &gt;= 1000 cells/mm3; Criterion B: WBC &lt;= 2000 cells/mm3 or ANC &lt;= 1000 cells/mm3; Criterion C: participants who are discontinued or permanently suspended due to WBC or ANC findings; Criterion D: ANC &lt;= 500 cells/mm3</description>
          <population>All participants with at least one dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Criterion A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="8.63"/>
                    <measurement group_id="O2" value="1" spread="7.30"/>
                    <measurement group_id="O3" value="0" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.</description>
        <time_frame>Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
        <population>All participants with at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.</description>
          <population>All participants with at least one dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" spread="8.63"/>
                    <measurement group_id="O2" value="82" spread="7.30"/>
                    <measurement group_id="O3" value="63" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events</title>
        <description>Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.</description>
        <time_frame>Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
        <population>All participants with at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events</title>
          <description>Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.</description>
          <population>All participants with at least one dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" spread="8.63"/>
                    <measurement group_id="O2" value="2" spread="7.30"/>
                    <measurement group_id="O3" value="7" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormalities)</title>
        <description>Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], urine specific gravity, glucose, protein, blood, ketones, nitrite).</description>
        <time_frame>Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
        <population>All participants with at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormalities)</title>
          <description>Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], urine specific gravity, glucose, protein, blood, ketones, nitrite).</description>
          <population>All participants with at least one dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47" spread="8.63"/>
                    <measurement group_id="O2" value="46" spread="7.30"/>
                    <measurement group_id="O3" value="48" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Laboratory Test Abnormalities (With Normal Baseline)</title>
        <description>Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], urine specific gravity, glucose, protein, blood, ketones, nitrite).</description>
        <time_frame>Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
        <population>All participants with at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Test Abnormalities (With Normal Baseline)</title>
          <description>Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], urine specific gravity, glucose, protein, blood, ketones, nitrite).</description>
          <population>All participants with at least one dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40" spread="8.63"/>
                    <measurement group_id="O2" value="36" spread="7.30"/>
                    <measurement group_id="O3" value="41" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Absolute Values)</title>
        <description>Absolute values were analyzed for supine systolic blood pressure (SBP), standing SBP, supine diastolic blood pressure (DBP), standing DBP, supine pulse rate, and standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: Criterion A: supine SBP less than (&lt;) 90 millimeter of mercury(mmHg); Criterion B: standing SBP &lt; 90 mmHg; Criterion C: supine DBP &lt;50 mmHg; Criterion D: standing DBP &lt;50 mmHg; Criterion E: supine pulse rate &lt; 40 beats per minute(BPM); Criterion F: supine pulse rate greater than (&gt;)120 BPM; Criterion G: standing pulse rate &lt; 40 beats per minute(BPM); Criterion H: standing pulse rate &gt;120 BPM;</description>
        <time_frame>Screening, Day 1, 28, 91, and 182</time_frame>
        <population>All participants with at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Absolute Values)</title>
          <description>Absolute values were analyzed for supine systolic blood pressure (SBP), standing SBP, supine diastolic blood pressure (DBP), standing DBP, supine pulse rate, and standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: Criterion A: supine SBP less than (&lt;) 90 millimeter of mercury(mmHg); Criterion B: standing SBP &lt; 90 mmHg; Criterion C: supine DBP &lt;50 mmHg; Criterion D: standing DBP &lt;50 mmHg; Criterion E: supine pulse rate &lt; 40 beats per minute(BPM); Criterion F: supine pulse rate greater than (&gt;)120 BPM; Criterion G: standing pulse rate &lt; 40 beats per minute(BPM); Criterion H: standing pulse rate &gt;120 BPM;</description>
          <population>All participants with at least one dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Criterion A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="8.63"/>
                    <measurement group_id="O2" value="0" spread="7.30"/>
                    <measurement group_id="O3" value="0" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion E</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion F</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion G</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion H</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Increase From Baseline)</title>
        <description>The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine SBP greater than or equal to (&gt;=) 30 mmHg; Criterion B: maximum increase from baseline in standing SBP &gt;= 30 mmHg; Criterion C: maximum increase from baseline in supine DBP &gt;=20 mmHg; Criterion D: maximum increase from baseline in standing DBP &gt;=20 mmHg</description>
        <time_frame>Screening, Day 1, 28, 91, and 182</time_frame>
        <population>All participants with at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Increase From Baseline)</title>
          <description>The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine SBP greater than or equal to (&gt;=) 30 mmHg; Criterion B: maximum increase from baseline in standing SBP &gt;= 30 mmHg; Criterion C: maximum increase from baseline in supine DBP &gt;=20 mmHg; Criterion D: maximum increase from baseline in standing DBP &gt;=20 mmHg</description>
          <population>All participants with at least one dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Criterion A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="8.63"/>
                    <measurement group_id="O2" value="1" spread="7.30"/>
                    <measurement group_id="O3" value="4" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Decrease From Baseline)</title>
        <description>The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine SBP &gt;= 30 mmHg; Criterion B: maximum decrease from baseline in standing SBP &gt;= 30 mmHg; Criterion C: maximum decrease from baseline in supine DBP &gt;=20 mmHg; Criterion D: maximum decrease from baseline in standing DBP &gt;=20 mmHg</description>
        <time_frame>Screening, Day 1, 28, 91, and 182</time_frame>
        <population>All participants with at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Decrease From Baseline)</title>
          <description>The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine SBP &gt;= 30 mmHg; Criterion B: maximum decrease from baseline in standing SBP &gt;= 30 mmHg; Criterion C: maximum decrease from baseline in supine DBP &gt;=20 mmHg; Criterion D: maximum decrease from baseline in standing DBP &gt;=20 mmHg</description>
          <population>All participants with at least one dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Criterion A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="8.63"/>
                    <measurement group_id="O2" value="7" spread="7.30"/>
                    <measurement group_id="O3" value="3" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Absolute Values)</title>
        <description>The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) &gt;=300 msec; Criterion B: maximum QRS complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) &gt;=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula) 450-&lt;480 msec; Criterion D: maximum QTcF interval 480-&lt;500 msec; Criterion E: maximum QTcF interval (Fridericia's correction) &gt;=500 msec</description>
        <time_frame>Screening, Day 1, 28, 91, and 182</time_frame>
        <population>All participants with at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Absolute Values)</title>
          <description>The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) &gt;=300 msec; Criterion B: maximum QRS complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) &gt;=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula) 450-&lt;480 msec; Criterion D: maximum QTcF interval 480-&lt;500 msec; Criterion E: maximum QTcF interval (Fridericia's correction) &gt;=500 msec</description>
          <population>All participants with at least one dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="93"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Criterion A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="8.63"/>
                    <measurement group_id="O2" value="0" spread="7.30"/>
                    <measurement group_id="O3" value="0" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion E</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Increase From Baseline)</title>
        <description>Number of participants with ECG meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)&gt;= 25/50%; Criterion B: maximum QRS complex increase from baseline PctChg &gt;=50%; Criterion C: maximum QTcF interval (Fridericia's correction) increase from baseline 30&lt;=change&lt;60 msec; Criterion D: maximum QTcF interval (Fridericia's correction) increase from baseline change &gt;=60 msec.</description>
        <time_frame>Screening, Day 1, 28, 91, and 182</time_frame>
        <population>All participants with at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Increase From Baseline)</title>
          <description>Number of participants with ECG meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)&gt;= 25/50%; Criterion B: maximum QRS complex increase from baseline PctChg &gt;=50%; Criterion C: maximum QTcF interval (Fridericia's correction) increase from baseline 30&lt;=change&lt;60 msec; Criterion D: maximum QTcF interval (Fridericia's correction) increase from baseline change &gt;=60 msec.</description>
          <population>All participants with at least one dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="93"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Criterion A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="8.63"/>
                    <measurement group_id="O2" value="0" spread="7.30"/>
                    <measurement group_id="O3" value="0" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Criterion D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of Adverse Events Related to Extrapyramidal Symptoms (EPS) Including Dystonia and Akathisia</title>
        <description>Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event). EPS were reported AEs of dystonia and akathisia.</description>
        <time_frame>Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
        <population>All participants with at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Adverse Events Related to Extrapyramidal Symptoms (EPS) Including Dystonia and Akathisia</title>
          <description>Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event). EPS were reported AEs of dystonia and akathisia.</description>
          <population>All participants with at least one dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dystonia(Mild)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="8.63"/>
                    <measurement group_id="O2" value="0" spread="7.30"/>
                    <measurement group_id="O3" value="0" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dystonia(Moderate)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dystonia(Severe)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Akathisia(Mild)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Akathisia(Moderate)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Akathisia(Severe)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Total Maximum Chorea (TMC) Score of the UHDRS After 13 and 26 Weeks of Treatment.</title>
        <description>The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The Total Maximum Chorea (TMC) was a subset of the TMS assessment. It was composed of the scoring of 7 chorea assessments (face, orobuccolingual, trunk, right and left upper extremities, right and left lower extremities). Each assessment was rated from 0 to 4 (absent to prolonged). TMC is obtained by adding up each of the separate scores, leading to max score of 28. The minimum score is 0. The higher the score, the worse the symptoms. n is the number of evaluable subjects in each visit.</description>
        <time_frame>Baseline, Week 13, Week 26</time_frame>
        <population>All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements did not contribute to the analysis, except in the description of the baseline values.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Total Maximum Chorea (TMC) Score of the UHDRS After 13 and 26 Weeks of Treatment.</title>
          <description>The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The Total Maximum Chorea (TMC) was a subset of the TMS assessment. It was composed of the scoring of 7 chorea assessments (face, orobuccolingual, trunk, right and left upper extremities, right and left lower extremities). Each assessment was rated from 0 to 4 (absent to prolonged). TMC is obtained by adding up each of the separate scores, leading to max score of 28. The minimum score is 0. The higher the score, the worse the symptoms. n is the number of evaluable subjects in each visit.</description>
          <population>All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements did not contribute to the analysis, except in the description of the baseline values.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="3.92"/>
                    <measurement group_id="O2" value="-0.2" spread="3.50"/>
                    <measurement group_id="O3" value="-0.9" spread="2.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="3.81"/>
                    <measurement group_id="O2" value="-0.4" spread="2.84"/>
                    <measurement group_id="O3" value="-0.8" spread="2.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 13</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0030</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.54</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.515</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>2.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 13</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4656</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.36</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.491</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.45</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0149</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.492</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.39</ci_lower_limit>
            <ci_upper_limit>2.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8233</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.10</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.460</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.66</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Follow-up Visit</title>
        <description>The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.</description>
        <time_frame>Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
        <population>All participants with at least one dose of study medication.n is the number of evaluable participants in each visit</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Follow-up Visit</title>
          <description>The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.</description>
          <population>All participants with at least one dose of study medication.n is the number of evaluable participants in each visit</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Completed Suicide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="8.63"/>
                    <measurement group_id="O2" value="0" spread="7.30"/>
                    <measurement group_id="O3" value="0" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicide Attempt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Imminent Suicidal Behavior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicidal Ideation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-Injurious Behavior, No Suicidal Attempt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Global Impression of Improvement (CGI-I) Scale Score After 13 and 26 Weeks of Treatment.</title>
        <description>CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: &quot;Compared to your subject's condition at the beginning of treatment, how much has your subject changed?&quot;. Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. n is the number of evaluable participants in each visit.</description>
        <time_frame>Week 13 &amp; Week 26</time_frame>
        <population>All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements will not contribute to the analysis, except in the description of the baseline values.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-02545920 20 mg BID</title>
            <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O2">
            <title>PF-02545920 5 mg BID</title>
            <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression of Improvement (CGI-I) Scale Score After 13 and 26 Weeks of Treatment.</title>
          <description>CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: &quot;Compared to your subject's condition at the beginning of treatment, how much has your subject changed?&quot;. Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. n is the number of evaluable participants in each visit.</description>
          <population>All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements will not contribute to the analysis, except in the description of the baseline values.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="1.00"/>
                    <measurement group_id="O2" value="3.7" spread="0.90"/>
                    <measurement group_id="O3" value="3.6" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="1.13"/>
                    <measurement group_id="O2" value="3.8" spread="0.99"/>
                    <measurement group_id="O3" value="3.8" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 13</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0181</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.35</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.148</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.11</ci_lower_limit>
            <ci_upper_limit>0.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 13</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7133</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.140</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.18</ci_lower_limit>
            <ci_upper_limit>0.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4657</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.12</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.163</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.15</ci_lower_limit>
            <ci_upper_limit>0.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 26</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8339</p_value>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.150</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.22</ci_lower_limit>
            <ci_upper_limit>0.28</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)</time_frame>
      <desc>The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>PF-02545920 5 mg BID</title>
          <description>Participants took 4 tablets packaged in blister packs (3 placebo tablets and one 5 mg PF-02545920) twice a day approximately every 12 hours from Baseline Day 1 (V2) to Week 26 (V9), at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants took 4 tablets of placebo packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
        </group>
        <group group_id="E3">
          <title>PF-02545920 20 mg BID</title>
          <description>The 20 mg BID dose of PF-02545920 was titrated as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Participants took 4 tablets packaged in blister packs twice a day approximately every 12 hours, at approximately the same time of day throughout the study. The blister packs contained 3 placebo tablets and one 5 mg PF-02545920 tablet for Days 1-7, 2 placebo tablets and two 5 mg PF-02545920 tablets for Days 8-14, 1 placebo tablet and three 5 mg PF-02545920 tablets for Days 15-21, and four 5 mg PF-02545920 tablets from Day 22 through Day 182. Study medication was swallowed whole, and was not manipulated or chewed prior to swallowing.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Vestibular migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Acute stress disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Suicidal behaviour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asphyxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="71" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="65" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Chorea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>18007181021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02197130
org study id: A8241021
secondary id: 2014-001291-56
nct id: NCT02197130
lead sponsor: 
has dmc: Yes
This study is a 26 week, randomized, parallel group, double blind comparison of PF-02545920 5
      mg, PF-02545920 20 mg, and placebo dosed BID in the treatment of motor impairment of subjects
      with Huntington's Disease. A total of approximately 260 subjects are planned to be randomized
      in the study. Primary endpoint is the change from baseline in the Total Motor Score (TMS)
      assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 26 weeks of
      treatment. secondary endpoints will include change from baseline in the Total Maximum Chorea
      (TMC) score of the UHDRS after 13 and 26 weeks of treatment and Clinical Global
      Impression-Improvement score after 13 and 26 weeks of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment.
time frame: Baseline, Week 26
description: The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of Huntington's Disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The total motor score (TMS) assessed motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. Some items (such as chorea and dystonia) required grading each extremity (face, bucco-oral-lingual, and trunk) separately. Eye movements require both horizontal and vertical grades. The total motor impairment scores was the sum of all the individual 31 motor sub-items (each rated from 0 to 4), with higher scores indicating more severe motor impairment than lower scores. The range of TMS is 0-124.
measure: Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria
time frame: Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
description: The criteria for temporary study suspension was as follow: Criterion A: WBC count <=3000 cells/mm3 but >= 2000 cells/mm3 or ANC <= 1500 cells/mm3 but >= 1000 cells/mm3; Criterion B: WBC <= 2000 cells/mm3 or ANC <= 1000 cells/mm3; Criterion C: participants who are discontinued or permanently suspended due to WBC or ANC findings; Criterion D: ANC <= 500 cells/mm3
measure: Number of Participants With Adverse Events
time frame: Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
description: Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
measure: Number of Participants With Serious Adverse Events
time frame: Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
description: Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
measure: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormalities)
time frame: Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
description: Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], urine specific gravity, glucose, protein, blood, ketones, nitrite).
measure: Number of Participants With Laboratory Test Abnormalities (With Normal Baseline)
time frame: Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
description: Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], urine specific gravity, glucose, protein, blood, ketones, nitrite).
measure: Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Absolute Values)
time frame: Screening, Day 1, 28, 91, and 182
description: Absolute values were analyzed for supine systolic blood pressure (SBP), standing SBP, supine diastolic blood pressure (DBP), standing DBP, supine pulse rate, and standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: Criterion A: supine SBP less than (<) 90 millimeter of mercury(mmHg); Criterion B: standing SBP < 90 mmHg; Criterion C: supine DBP <50 mmHg; Criterion D: standing DBP <50 mmHg; Criterion E: supine pulse rate < 40 beats per minute(BPM); Criterion F: supine pulse rate greater than (>)120 BPM; Criterion G: standing pulse rate < 40 beats per minute(BPM); Criterion H: standing pulse rate >120 BPM;
measure: Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Increase From Baseline)
time frame: Screening, Day 1, 28, 91, and 182
description: The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine SBP greater than or equal to (>=) 30 mmHg; Criterion B: maximum increase from baseline in standing SBP >= 30 mmHg; Criterion C: maximum increase from baseline in supine DBP >=20 mmHg; Criterion D: maximum increase from baseline in standing DBP >=20 mmHg
measure: Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Decrease From Baseline)
time frame: Screening, Day 1, 28, 91, and 182
description: The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine SBP >= 30 mmHg; Criterion B: maximum decrease from baseline in standing SBP >= 30 mmHg; Criterion C: maximum decrease from baseline in supine DBP >=20 mmHg; Criterion D: maximum decrease from baseline in standing DBP >=20 mmHg
measure: Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Absolute Values)
time frame: Screening, Day 1, 28, 91, and 182
description: The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) >=300 msec; Criterion B: maximum QRS complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) >=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula) 450-<480 msec; Criterion D: maximum QTcF interval 480-<500 msec; Criterion E: maximum QTcF interval (Fridericia's correction) >=500 msec
measure: Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Increase From Baseline)
time frame: Screening, Day 1, 28, 91, and 182
description: Number of participants with ECG meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)>= 25/50%; Criterion B: maximum QRS complex increase from baseline PctChg >=50%; Criterion C: maximum QTcF interval (Fridericia's correction) increase from baseline 30<=change<60 msec; Criterion D: maximum QTcF interval (Fridericia's correction) increase from baseline change >=60 msec.
measure: Severity of Adverse Events Related to Extrapyramidal Symptoms (EPS) Including Dystonia and Akathisia
time frame: Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
description: Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event). EPS were reported AEs of dystonia and akathisia.
measure: Change From Baseline in the Total Maximum Chorea (TMC) Score of the UHDRS After 13 and 26 Weeks of Treatment.
time frame: Baseline, Week 13, Week 26
description: The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The Total Maximum Chorea (TMC) was a subset of the TMS assessment. It was composed of the scoring of 7 chorea assessments (face, orobuccolingual, trunk, right and left upper extremities, right and left lower extremities). Each assessment was rated from 0 to 4 (absent to prolonged). TMC is obtained by adding up each of the separate scores, leading to max score of 28. The minimum score is 0. The higher the score, the worse the symptoms. n is the number of evaluable subjects in each visit.
measure: Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Follow-up Visit
time frame: Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)
description: The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
measure: Clinical Global Impression of Improvement (CGI-I) Scale Score After 13 and 26 Weeks of Treatment.
time frame: Week 13 & Week 26
description: CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: "Compared to your subject's condition at the beginning of treatment, how much has your subject changed?". Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. n is the number of evaluable participants in each visit.
arm group label: 20 mg PF-02545920 BID
arm group type: Experimental
description: 20 mg PF-02545920 BID
arm group label: 5 mg PF-02545920 BID
arm group type: Experimental
description: 5 mg PF-02545920 BID
arm group label: Placebo BID
arm group type: Placebo Comparator
description: Matching placebo
intervention type: Drug
intervention name: PF-02545920
description: 20 mg twice a day (BID) for 26 weeks. Each 20 mg dose will be taken as 4 tablets of 5 mg. The 20mg dose will be titrated as follow: 5mg BID for 7 days, 10mg BID for 7 days, 15 mg BID for 7 days and 20 mg BID to week 26. Study drug will be provided in weekly blister cards.
arm group label: 20 mg PF-02545920 BID
intervention type: Drug
intervention name: PF-02545920
description: 5 mg twice a day (BID) for 26 weeks. Each 5 mg dose will be taken as 4 tablets: one tablet of 5 mg and 3 tablets of matching placebo. The 5mg dose will not be titrated. Study drug will be provided in weekly blister cards.
arm group label: 5 mg PF-02545920 BID
intervention type: Other
intervention name: Placebo
description: Matching Placebo twice a day (BID) for 26 weeks. Each placebo dose will be taken as 4 tablets of matching Placebo. The placebo dose will not be titrated. Matching placebo will be provided in weekly blister cards.
arm group label: Placebo BID
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Canada
country: Germany
country: Poland
country: United Kingdom
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8241021
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Huntington Disease
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 