<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/NCT02240030</url>
  </required_header>
  <id_info>
    <org_study_id>CVT-301-004</org_study_id>
    <nct_id>NCT02240030</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes</brief_title>
  <acronym>SPAN-PD™</acronym>
  <official_title>A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acorda Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acorda Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized, multicenter, placebo-controlled, double-blind study will evaluate the&#xD;
      efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing&#xD;
      motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the&#xD;
      clinic.&#xD;
&#xD;
      Patients who successfully complete this study will be eligible to enroll into a 12 month&#xD;
      treatment extension (CVT-301-004E) study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 3</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>Unified Parkinson's Disease Rating Scale (UPDRS) Part III</measure>
    <time_frame>30 minutes post-dose at week 12</time_frame>
    <description>Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.</measure>
    <time_frame>at week 12</time_frame>
    <description>Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UPDRS Part III Motor Score at 20 Minutes</measure>
    <time_frame>at week 12</time_frame>
    <description>Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 20 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population) and CVT 301 Low Dose versus Placebo. UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12</measure>
    <time_frame>week 12</time_frame>
    <description>Patient Global impression of change at treatment visit 4 (week 12) by improvement category. Seven point Likert scale ranging from 1= much worse to 7= much better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UPDRS Part III at 10 Min.</measure>
    <time_frame>week 12</time_frame>
    <description>Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 10 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PD Patient Diary</measure>
    <time_frame>post week 12</time_frame>
    <description>Change in total daily OFF times for 3 consecutive days prior to week 12 visit compared to 3 consecutive days prior to baseline visit. Participants recorded On or Off state in 30 minute intervals during waking hours.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">351</enrollment>
  <condition>Idiopathic Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>CVT-301 Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CVT-301 High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CVT-301 Low Dose</intervention_name>
    <arm_group_label>CVT-301 Low Dose</arm_group_label>
    <other_name>Inhaled levodopa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CVT-301 High Dose</intervention_name>
    <arm_group_label>CVT-301 High Dose</arm_group_label>
    <other_name>Inhaled levodopa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Inhalation-grade lactose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 years;&#xD;
&#xD;
          -  Hoehn and Yahr Stage 1-3 in an &quot;on&quot; state;&#xD;
&#xD;
          -  Require levodopa-containing medication regimen at least 3 times during the waking day;&#xD;
&#xD;
          -  Experience motor fluctuations with a minimum of 2 hours of average daily &quot;off&quot; time&#xD;
             per waking day (excluding early morning &quot;off&quot; time) and demonstrate levodopa&#xD;
             responsiveness;&#xD;
&#xD;
          -  Are on stable PD medication regimen;&#xD;
&#xD;
          -  Total daily LD dose &lt;1600 mg/day;&#xD;
&#xD;
          -  Able to perform a spirometry maneuver in the ON and OFF states;&#xD;
&#xD;
          -  Normal cognition confirmed by MMSE score ≥25&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating females;&#xD;
&#xD;
          -  Previous surgery for PD or plan to have stereotactic surgery during the study period;&#xD;
&#xD;
          -  History of psychotic symptoms requiring treatment, or suicide ideation or attempt&#xD;
             within last year;&#xD;
&#xD;
          -  Known contraindication to the use of levodopa;&#xD;
&#xD;
          -  Any significant condition, severe concurrent disease, abnormality or finding that&#xD;
             would make patients unsuitable or may compromise patient safety;&#xD;
&#xD;
          -  Any contraindication to performing routine spirometry.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Oh, MD</last_name>
    <role>Study Director</role>
    <affiliation>Acorda Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Acorda Site #5020</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5042</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5064</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5035</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5027</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5037</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5070</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5047</name>
      <address>
        <city>Reseda</city>
        <state>California</state>
        <zip>91335</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5068</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5069</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5052</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5046</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5053</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5013</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5016</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5071</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5044</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5060</name>
      <address>
        <city>Palm Beach Gardens</city>
        <state>Florida</state>
        <zip>33410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5001</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5065</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5012</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5040</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5025</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5030</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5011</name>
      <address>
        <city>Elk Grove Village</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5003</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5067</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5057</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5056</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5018</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5002</name>
      <address>
        <city>Bingham Farms</city>
        <state>Michigan</state>
        <zip>48025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5014</name>
      <address>
        <city>West Bloomfield</city>
        <state>Michigan</state>
        <zip>48322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5041</name>
      <address>
        <city>Golden Valley</city>
        <state>Minnesota</state>
        <zip>55427</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5006</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5023</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5028</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5039</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5031</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5032</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5004</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5038</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5048</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5005</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5050</name>
      <address>
        <city>Norwood</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5062</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5036</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5010</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5058</name>
      <address>
        <city>Willow Grove</city>
        <state>Pennsylvania</state>
        <zip>19090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5022</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5029</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>372322551</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5019</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5045</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5049</name>
      <address>
        <city>Henrico</city>
        <state>Virginia</state>
        <zip>23226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5059</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5051</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5103</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5104</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5105</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5201</name>
      <address>
        <city>Prague</city>
        <zip>10000</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5203</name>
      <address>
        <city>Prague</city>
        <zip>14000</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5304</name>
      <address>
        <city>Katowice</city>
        <zip>40588</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5303</name>
      <address>
        <city>Krakow</city>
        <zip>30510</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5306</name>
      <address>
        <city>Kraków</city>
        <zip>30349</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5307</name>
      <address>
        <city>Kraków</city>
        <zip>31505</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5302</name>
      <address>
        <city>Lodz</city>
        <zip>90130</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5308</name>
      <address>
        <city>Warsaw</city>
        <zip>00453</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5301</name>
      <address>
        <city>Warsaw</city>
        <zip>01868</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5305</name>
      <address>
        <city>Zaspa</city>
        <zip>80462</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5407</name>
      <address>
        <city>Pamplona</city>
        <state>Navarre</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5404</name>
      <address>
        <city>Barcelona</city>
        <zip>08026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5406</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5405</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5403</name>
      <address>
        <city>San Sebastián</city>
        <zip>20009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acorda Site #5401</name>
      <address>
        <city>Sant Cugat Del Vallès</city>
        <zip>08190</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>http://cvt301.acordatrials.com/en/patient/?src=clinicaltrialsgov004</url>
    <description>Click here for more information about this study: CVT-301-004</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <results_first_submitted>January 23, 2018</results_first_submitted>
  <results_first_submitted_qc>March 15, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">April 17, 2018</results_first_posted>
  <last_update_submitted>May 23, 2019</last_update_submitted>
  <last_update_submitted_qc>May 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's Disease</keyword>
  <keyword>Motor fluctuations</keyword>
  <keyword>levodopa</keyword>
  <keyword>inhaled drugs</keyword>
  <keyword>OFF episodes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levodopa</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CVT-301 Low Dose</title>
          <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
        </group>
        <group group_id="P2">
          <title>CVT-301 High Dose</title>
          <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.&#xD;
CVT-301</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="113"/>
                <participants group_id="P2" count="114"/>
                <participants group_id="P3" count="112"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
                <participants group_id="P2" count="97"/>
                <participants group_id="P3" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose.</population>
      <group_list>
        <group group_id="B1">
          <title>CVT-301 Low Dose</title>
          <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
        </group>
        <group group_id="B2">
          <title>CVT-301 High Dose</title>
          <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.&#xD;
CVT-301</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="113"/>
            <count group_id="B2" value="114"/>
            <count group_id="B3" value="112"/>
            <count group_id="B4" value="339"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="167"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="57"/>
                    <measurement group_id="B4" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="63.9" spread="9.24"/>
                    <measurement group_id="B2" value="63.5" spread="7.97"/>
                    <measurement group_id="B3" value="62.6" spread="8.83"/>
                    <measurement group_id="B4" value="63.3" spread="8.69"/>
                  </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="33"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="86"/>
                    <measurement group_id="B4" value="249"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="81"/>
                    <measurement group_id="B4" value="248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Unified Parkinson's Disease Rating Scale (UPDRS) Part III</title>
        <description>Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.</description>
        <time_frame>30 minutes post-dose at week 12</time_frame>
        <population>12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).</population>
        <group_list>
          <group group_id="O1">
            <title>CVT-301 High Dose</title>
            <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.&#xD;
CVT-301</description>
          </group>
        </group_list>
        <measure>
          <title>Unified Parkinson's Disease Rating Scale (UPDRS) Part III</title>
          <description>Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.</description>
          <population>12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.83" spread="1.506"/>
                    <measurement group_id="O2" value="-5.91" spread="1.500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.</title>
        <description>Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed</description>
        <time_frame>at week 12</time_frame>
        <population>12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).</population>
        <group_list>
          <group group_id="O1">
            <title>CVT-301 Low Dose</title>
            <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
          </group>
          <group group_id="O2">
            <title>CVT-301 High Dose</title>
            <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.&#xD;
CVT-301</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.</title>
          <description>Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed</description>
          <population>12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="113"/>
                <count group_id="O2" value="114"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>UPDRS Part III Motor Score at 20 Minutes</title>
        <description>Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 20 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population) and CVT 301 Low Dose versus Placebo. UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.</description>
        <time_frame>at week 12</time_frame>
        <population>12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).</population>
        <group_list>
          <group group_id="O1">
            <title>CVT-301 Low Dose</title>
            <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
          </group>
          <group group_id="O2">
            <title>CVT-301 High Dose</title>
            <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.&#xD;
CVT-301</description>
          </group>
        </group_list>
        <measure>
          <title>UPDRS Part III Motor Score at 20 Minutes</title>
          <description>Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 20 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population) and CVT 301 Low Dose versus Placebo. UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.</description>
          <population>12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>97.5% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="113"/>
                <count group_id="O2" value="114"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.47" lower_limit="-11.11" upper_limit="-5.82"/>
                    <measurement group_id="O2" value="-9.04" lower_limit="-11.70" upper_limit="-6.37"/>
                    <measurement group_id="O3" value="-6.49" lower_limit="-9.15" upper_limit="-3.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12</title>
        <description>Patient Global impression of change at treatment visit 4 (week 12) by improvement category. Seven point Likert scale ranging from 1= much worse to 7= much better.</description>
        <time_frame>week 12</time_frame>
        <population>12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).</population>
        <group_list>
          <group group_id="O1">
            <title>CVT-301 Low Dose</title>
            <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
          </group>
          <group group_id="O2">
            <title>CVT-301 High Dose</title>
            <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.&#xD;
CVT-301</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12</title>
          <description>Patient Global impression of change at treatment visit 4 (week 12) by improvement category. Seven point Likert scale ranging from 1= much worse to 7= much better.</description>
          <population>12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="113"/>
                <count group_id="O2" value="114"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="70"/>
                    <measurement group_id="O3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>UPDRS Part III at 10 Min.</title>
        <description>Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 10 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.</description>
        <time_frame>week 12</time_frame>
        <population>12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).</population>
        <group_list>
          <group group_id="O1">
            <title>CVT-301 Low Dose</title>
            <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
          </group>
          <group group_id="O2">
            <title>CVT-301 High Dose</title>
            <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.&#xD;
CVT-301</description>
          </group>
        </group_list>
        <measure>
          <title>UPDRS Part III at 10 Min.</title>
          <description>Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 10 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.</description>
          <population>12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="113"/>
                <count group_id="O2" value="114"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.16" lower_limit="-7.31" upper_limit="-3.00"/>
                    <measurement group_id="O2" value="-6.45" lower_limit="-8.62" upper_limit="-4.27"/>
                    <measurement group_id="O3" value="-4.18" lower_limit="-6.35" upper_limit="-2.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PD Patient Diary</title>
        <description>Change in total daily OFF times for 3 consecutive days prior to week 12 visit compared to 3 consecutive days prior to baseline visit. Participants recorded On or Off state in 30 minute intervals during waking hours.</description>
        <time_frame>post week 12</time_frame>
        <population>12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).</population>
        <group_list>
          <group group_id="O1">
            <title>CVT-301 Low Dose</title>
            <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
          </group>
          <group group_id="O2">
            <title>CVT-301 High Dose</title>
            <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.&#xD;
CVT-301</description>
          </group>
        </group_list>
        <measure>
          <title>PD Patient Diary</title>
          <description>Change in total daily OFF times for 3 consecutive days prior to week 12 visit compared to 3 consecutive days prior to baseline visit. Participants recorded On or Off state in 30 minute intervals during waking hours.</description>
          <population>12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).</population>
          <units>hours</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="113"/>
                <count group_id="O2" value="114"/>
                <count group_id="O3" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.58" lower_limit="-1.13" upper_limit="-0.03"/>
                    <measurement group_id="O2" value="-0.47" lower_limit="-1.02" upper_limit="0.09"/>
                    <measurement group_id="O3" value="-0.48" lower_limit="-1.03" upper_limit="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 Week Study</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CVT-301 Low Dose</title>
          <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
        </group>
        <group group_id="E2">
          <title>CVT-301 High Dose</title>
          <description>Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration&#xD;
CVT-301</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.&#xD;
CVT-301</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Lumbar spinal stinosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <default_assessment>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="37" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="112"/>
              </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="5" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Throat Irritation</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Sputum discoloured</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="114"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding the study results for a period up to 30 days from the date the communication is submitted to the sponsor. The sponsor shall have the right to defer proposed publication an additional 60 days from the end of the review period. The sponsor cannot require changes to the communication and cannot unilaterally extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Charles Oh</name_or_title>
      <organization>Acorda Therapeutics</organization>
      <phone>914-326-5455</phone>
      <email>coh@acorda.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/NCT02240030
org study id: CVT-301-004
nct id: NCT02240030
lead sponsor: 
has dmc: Yes
This randomized, multicenter, placebo-controlled, double-blind study will evaluate the
      efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing
      motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the
      clinic.

      Patients who successfully complete this study will be eligible to enroll into a 12 month
      treatment extension (CVT-301-004E) study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Part III
time frame: 30 minutes post-dose at week 12
description: Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
measure: Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.
time frame: at week 12
description: Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed
measure: UPDRS Part III Motor Score at 20 Minutes
time frame: at week 12
description: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 20 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population) and CVT 301 Low Dose versus Placebo. UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
measure: Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12
time frame: week 12
description: Patient Global impression of change at treatment visit 4 (week 12) by improvement category. Seven point Likert scale ranging from 1= much worse to 7= much better.
measure: UPDRS Part III at 10 Min.
time frame: week 12
description: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 10 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
measure: PD Patient Diary
time frame: post week 12
description: Change in total daily OFF times for 3 consecutive days prior to week 12 visit compared to 3 consecutive days prior to baseline visit. Participants recorded On or Off state in 30 minute intervals during waking hours.
arm group label: CVT-301 Low Dose
arm group type: Experimental
description: Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
arm group label: CVT-301 High Dose
arm group type: Experimental
description: Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
arm group label: Placebo
arm group type: Placebo Comparator
description: Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.
intervention type: Drug
intervention name: CVT-301 Low Dose
arm group label: CVT-301 Low Dose
other name: Inhaled levodopa
intervention type: Drug
intervention name: CVT-301 High Dose
arm group label: CVT-301 High Dose
other name: Inhaled levodopa
intervention type: Other
intervention name: Placebo
arm group label: Placebo
other name: Inhalation-grade lactose
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: No
last name: Charles Oh, MD
role: Study Director
affiliation: Acorda Therapeutics
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country: Canada
country: Czechia
country: Poland
country: Spain
country: United States
country: Czech Republic
url: http://cvt301.acordatrials.com/en/patient/?src=clinicaltrialsgov004
description: Click here for more information about this study: CVT-301-004
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Levodopa
participant flow: 
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