<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/NCT03781167</url>
  </required_header>
  <id_info>
    <org_study_id>M15-741</org_study_id>
    <secondary_id>2018-002144-85</secondary_id>
    <nct_id>NCT03781167</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Tolerability of ABBV-951 in Participants With Parkinson's Disease (PD)</brief_title>
  <official_title>A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and tolerability of ABBV-951 in&#xD;
      participants with Parkinson's disease (PD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 29, 2019</start_date>
  <completion_date type="Actual">August 17, 2022</completion_date>
  <primary_completion_date type="Actual">August 17, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks)</time_frame>
    <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events of Special Interest</measure>
    <time_frame>From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks)</time_frame>
    <description>Treatment emergent adverse events of special interest defined as any adverse event of polyneuropathy or weight loss from the initiation of CSCI through 30 days after last infusion device is removed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of subjects with numeric grade equal to or higher than 5 and with letter grade equal to or higher than D on the Infusion Site Evaluation Scale</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The Infusion Site Evaluation Scale will be used to assess infusion sites.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hematocrit (Hematology): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin (Hematology): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Red Blood Cell (RBC) Count (Hematology): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>White blood cell (WBC) count (Hematology): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neutrophils (Hematology): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lymphocytes (Hematology): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monocytes (Hematology): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute platelet count (Hematology): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean corpuscular hemoglobin (Hematology): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean corpuscular volume concentration (MCHC) (Hematology): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prothrombin time (PT) (Hematology): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Activated partial thromboplastin time (Hematology): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood urea nitrogen (BUN) (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatinine (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatine phosphokinase (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total bilirubin (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum glutamic pyruvic transaminase (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum glutamic-oxaloacetic transaminase (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lactate dehydrogenase (LDH) (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gamma-glutamyl transpeptidase (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alkaline phosphatase (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sodium (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Potassium (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Calcium (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inorganic phosphorus (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Uric acid (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cholesterol (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Albumin (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glucose (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sodium bicarbonate/CO2 (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Magnesium (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatinine clearance (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin B6 (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin B12 (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Homocysteine (Clinical Chemistry): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specific gravity (Urinalysis): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ketones (Urinalysis): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pH (Urinalysis): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Protein (Urinalysis): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glucose (Urinalysis): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood (Urinalysis): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bilirubin (Urinalysis): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for clinical laboratory tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure (Vital Signs): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for vital signs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse rate (Vital Signs): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The change from baseline to end of study will be assessed for vital signs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants with Abnormal Electrocardiogram (ECG) Results</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>ECG recordings will be evaluated as 'normal' or 'abnormal'.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average normalized daily &quot;Off&quot; time and &quot;On&quot; times: Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>Average normalized daily &quot;Off&quot; time and &quot;On&quot; times as assessed by the Parkinson's Disease (PD) Diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parkinson's Disease (PD) symptoms: Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS- UPDRS) Parts I-IV (or the Unified Parkinson's Disease Rating Scale [UPDRS] Parts I-V where a validated translation of the MDS-UPDRS is not available).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The PDQ-39 is used to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep symptoms as assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2): Change from Baseline to end of study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The PDSS-2 is used to characterize the various aspects of nocturnal sleep problems in patients with PD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessed by EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Index Score: Change from Baseline to End of Study</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>The EQ-5D-5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">244</enrollment>
  <condition>Parkinson's Disease (PD)</condition>
  <arm_group>
    <arm_group_label>ABBV-951</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive ABBV-951 by continuous subcutaneous infusion (CSCI) for 52 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABBV-951</intervention_name>
    <description>solution for infusion</description>
    <arm_group_label>ABBV-951</arm_group_label>
    <other_name>Foscarbidopa</other_name>
    <other_name>Foslevodopa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa&#xD;
             -responsive&#xD;
&#xD;
          -  Participants must be judged by the investigator to be inadequately controlled by&#xD;
             current therapy, have recognizable/identifiable &quot;Off&quot; and &quot;On&quot; states (motor&#xD;
             fluctuations), and have a minimum of 2.5 hours of &quot;Off&quot; time per day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant is cognitively impaired and is not able to safely and effectively manage&#xD;
             the drug delivery system and the diaries and is not able to adhere to the study.&#xD;
&#xD;
          -  Participant is considered by the investigator to be an unsuitable candidate to receive&#xD;
             ABBV-951 for any reason.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham - Main /ID# 207996</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner Sun Health Res Inst /ID# 208811</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Parkinson's &amp; Movement Disorder Institute - Fountain Valley /ID# 216126</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital /ID# 207968</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 207677</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine /ID# 208812</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611-2927</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana Clinical Research Cent /ID# 207952</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ Kansas Med Ctr /ID# 208963</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Chandler Medical Center /ID# 207603</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital /ID# 207993</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Partners /ID# 207950</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55130-2400</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri /ID# 209043</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University-School of Medicine /ID# 207525</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center /ID# 207972</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 209784</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Legacy Medical Group - Neurology /ID# 208031</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97232-2003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute-Faris Road /ID# 207650</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605-4255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Consultants of Dallas - LBJ Fwy /ID# 207619</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75243-1188</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine /ID# 207620</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-4202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Texas Neurology Consul /ID# 216918</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ Texas HSC San Antonio /ID# 208958</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229-3901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Booth Gardner Parkinson's Care Center /ID# 208026</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034-3029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Northwest Research /ID# 208122</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202-1342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin /ID# 207999</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226-3522</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Concord Repatriation General Hospital /ID# 207628</name>
      <address>
        <city>Concord</city>
        <state>New South Wales</state>
        <zip>2139</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital /ID# 207633</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital /ID# 207634</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alfred Health /ID# 207632</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perron Institute /ID# 207627</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Leuven /ID# 209058</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Jan Brugge /ID# 208178</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Sante CHC - Clinique du MontLegia /ID# 208177</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary - Movement Disorders Clinic /ID# 207342</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche St-Louis /ID# 207344</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1W 4R4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bispebjerg and Frederiksberg Hospital /ID# 207669</name>
      <address>
        <city>Copenhagen NV</city>
        <state>Hovedstaden</state>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital /ID# 207668</name>
      <address>
        <city>Aarhus N</city>
        <state>Midtjylland</state>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital /ID# 207871</name>
      <address>
        <city>Odense C</city>
        <state>Syddanmark</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Ulm /ID# 208602</name>
      <address>
        <city>Ulm</city>
        <state>Baden-Wuerttemberg</state>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken Beelitz GmbH /ID# 208600</name>
      <address>
        <city>Beelitz-Heilstaetten</city>
        <zip>14547</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>InnKlinikum Haag /ID# 208601</name>
      <address>
        <city>Haag</city>
        <zip>83527</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Centro Neurolesi Bonino Pulejo /ID# 207975</name>
      <address>
        <city>Messina</city>
        <zip>98124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 207955</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Padova /ID# 208077</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Asahikawa Medical Center /ID# 210914</name>
      <address>
        <city>Asahikawa-shi</city>
        <state>Hokkaido</state>
        <zip>070-8644</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Utano National Hospital /ID# 210912</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>616-8255</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital /ID# 210913</name>
      <address>
        <city>Suita-shi</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juntendo University Hospital /ID# 210915</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Center of Neurology and Psychiatry /ID# 210911</name>
      <address>
        <city>Kodaira-shi</city>
        <state>Tokyo</state>
        <zip>187-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medisch Centrum /ID# 208168</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid-Holland</state>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis /ID# 208529</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3435 CM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital #40 /ID# 216301</name>
      <address>
        <city>Sestroretsk</city>
        <state>Sankt-Peterburg</state>
        <zip>197706</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 216303</name>
      <address>
        <city>St. Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>197101</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Elche /ID# 209777</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Bellvitge /ID# 209539</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario A Coruna - CHUAC /ID# 212147</name>
      <address>
        <city>A Coruna</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Creu i Sant Pau /ID# 208240</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de las Nieves /ID# 208242</name>
      <address>
        <city>Granada</city>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal /ID# 208241</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio /ID# 208239</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skane University Hospital Lund /ID# 207811</name>
      <address>
        <city>Lund</city>
        <state>Skane Lan</state>
        <zip>SE 221 41</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum for neurologi /ID# 207716</name>
      <address>
        <city>Stockholm</city>
        <state>Stockholms Lan</state>
        <zip>113 65</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital /ID# 207718</name>
      <address>
        <city>Gothenburg</city>
        <state>Vastra Gotalands Lan</state>
        <zip>413 46</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Tayside /ID# 209242</name>
      <address>
        <city>Dundee</city>
        <state>Scotland</state>
        <zip>DD2 1UB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital NHS Foundation Trust /ID# 208413</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Plymouth NHS Trust /ID# 208447</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 5FP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
  </removed_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>September 23, 2022</last_update_submitted>
  <last_update_submitted_qc>September 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's Disease (PD)</keyword>
  <keyword>ABBV-951</keyword>
  <keyword>Levodopa/Carbidopa</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>August 14, 2023</submitted>
    <returned>September 7, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03781167
org study id: M15-741
secondary id: 2018-002144-85
nct id: NCT03781167
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to assess the safety and tolerability of ABBV-951 in
      participants with Parkinson's disease (PD).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events
time frame: From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks)
description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
measure: Adverse Events of Special Interest
time frame: From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks)
description: Treatment emergent adverse events of special interest defined as any adverse event of polyneuropathy or weight loss from the initiation of CSCI through 30 days after last infusion device is removed
measure: Percentage of subjects with numeric grade equal to or higher than 5 and with letter grade equal to or higher than D on the Infusion Site Evaluation Scale
time frame: up to 52 weeks
description: The Infusion Site Evaluation Scale will be used to assess infusion sites.
measure: Hematocrit (Hematology): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Hemoglobin (Hematology): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Red Blood Cell (RBC) Count (Hematology): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: White blood cell (WBC) count (Hematology): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Neutrophils (Hematology): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Lymphocytes (Hematology): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Monocytes (Hematology): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Absolute platelet count (Hematology): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Mean corpuscular hemoglobin (Hematology): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Mean corpuscular volume concentration (MCHC) (Hematology): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Prothrombin time (PT) (Hematology): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Activated partial thromboplastin time (Hematology): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Blood urea nitrogen (BUN) (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Creatinine (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Creatine phosphokinase (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Total bilirubin (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Serum glutamic pyruvic transaminase (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Serum glutamic-oxaloacetic transaminase (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Lactate dehydrogenase (LDH) (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Gamma-glutamyl transpeptidase (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Alkaline phosphatase (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Sodium (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Potassium (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Calcium (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Inorganic phosphorus (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Uric acid (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Cholesterol (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Albumin (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Glucose (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Sodium bicarbonate/CO2 (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Magnesium (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Creatinine clearance (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Vitamin B6 (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Vitamin B12 (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Homocysteine (Clinical Chemistry): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Specific gravity (Urinalysis): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Ketones (Urinalysis): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: pH (Urinalysis): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Protein (Urinalysis): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Glucose (Urinalysis): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Blood (Urinalysis): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Bilirubin (Urinalysis): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for clinical laboratory tests.
measure: Blood pressure (Vital Signs): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for vital signs.
measure: Pulse rate (Vital Signs): Change from Baseline to end of study
time frame: up to 52 weeks
description: The change from baseline to end of study will be assessed for vital signs.
measure: Percentage of Participants with Abnormal Electrocardiogram (ECG) Results
time frame: up to 52 weeks
description: ECG recordings will be evaluated as 'normal' or 'abnormal'.
measure: Average normalized daily "Off" time and "On" times: Change from Baseline to end of study
time frame: up to 52 weeks
description: Average normalized daily "Off" time and "On" times as assessed by the Parkinson's Disease (PD) Diary.
measure: Parkinson's Disease (PD) symptoms: Change from Baseline to end of study
time frame: up to 52 weeks
description: PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS- UPDRS) Parts I-IV (or the Unified Parkinson's Disease Rating Scale [UPDRS] Parts I-V where a validated translation of the MDS-UPDRS is not available).
measure: Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39): Change from Baseline to end of study
time frame: up to 52 weeks
description: The PDQ-39 is used to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires.
measure: Sleep symptoms as assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2): Change from Baseline to end of study
time frame: up to 52 weeks
description: The PDSS-2 is used to characterize the various aspects of nocturnal sleep problems in patients with PD.
measure: Quality of Life Assessed by EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Index Score: Change from Baseline to End of Study
time frame: up to 52 weeks
description: The EQ-5D-5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.
arm group label: ABBV-951
arm group type: Experimental
description: Participants will receive ABBV-951 by continuous subcutaneous infusion (CSCI) for 52 weeks.
intervention type: Drug
intervention name: ABBV-951
description: solution for infusion
arm group label: ABBV-951
other name: Foscarbidopa
other name: Foslevodopa
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
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country: Australia
country: Belgium
country: Canada
country: Denmark
country: Germany
country: Italy
country: Japan
country: Netherlands
country: Russian Federation
country: Spain
country: Sweden
country: United Kingdom
country: United States
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
ipd url: https://vivli.org/ourmember/abbvie/
submitted: August 14, 2023
returned: September 7, 2023