<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/NCT02969369</url>
  </required_header>
  <id_info>
    <org_study_id>SEP361-203</org_study_id>
    <nct_id>NCT02969369</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis</brief_title>
  <official_title>A Multicenter Randomized Double-blind Followed by an Open-label Extension Study to Evaluate the Efficacy, Safety, and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sumitomo Pharma America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sumitomo Pharma America, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to evaluate the safety and tolerability of SEP-363856 in subjects with Parkinson's&#xD;
      Disease Psychosis. This study is accepting male and female participants 55 years of age and&#xD;
      older who have been diagnosed with Parkinson's Disease. This study will be conducted in 24&#xD;
      study centers in the United States.&#xD;
&#xD;
      The study will last approximately 21 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, randomized, parallel-group, placebo-controlled study evaluating the&#xD;
      efficacy, safety, and tolerability of double-blind SEP-363856 flexibly dosed at 25, 50, or 75&#xD;
      mg/day for 6 weeks followed by 12 weeks of open-label extension of SEP-363856 flexibly-dosed&#xD;
      at 25, 50, or 75 mg/day in male and female subjects ≥ 55 years of age with a clinical&#xD;
      diagnosis of PDP. The study will randomize approximately 36 subjects to 2 treatment groups in&#xD;
      a 2:1 ratio (approximately 24 subjects to SEP-363856 and 12 to placebo). The study will&#xD;
      consist of 4 periods: Screening/Washout Period (up to 14 days prior to Double-blind&#xD;
      Treatment), Double-blind Treatment Period (6 weeks), Open-label SEP-363856 Treatment Period&#xD;
      (12 weeks), and Follow-up Period (1 week after last dose) as shown in the following figure.&#xD;
      All postBaseline clinic visits will have a window of ± 2 days relative to the date of the&#xD;
      Baseline visit (Visit 3).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 31, 2016</start_date>
  <completion_date type="Actual">April 20, 2020</completion_date>
  <primary_completion_date type="Actual">April 20, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Double Blind (DB) Baseline in Total Scale for Assessment of Positive Symptoms - Parkinson's Disease ( SAPS-PD) Score at Week 6</measure>
    <time_frame>SAPS-PD assessments during DB treatment period, Baseline and Week 6</time_frame>
    <description>There are seven items assessing individual symptoms (four items for hallucinations and three items for delusions), a global hallucinations item and a global delusions item. Separate items are rated from 0 (absent) to 5 (severe), so that higher values represent a worse outcome. Total score is equal to the sum of the seven items plus the global hallucinations, plus the global delusions. Therefore a total possible score on the SAPS-PD ranges from 0 to 45.&#xD;
The primary analysis of the primary efficacy variable will use a mixed model for repeated measures (MMRM).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Double Blind (DB) Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) at Week 6.</measure>
    <time_frame>CGI-S assessments during DB treatment period, Baseline and Week 6</time_frame>
    <description>The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.&#xD;
Analysis Method: Mixed Model Repeated Measures (MMRM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Double Blind (DB) Baseline in Neuropsychiatric Inventory (NPI) at Week 6</measure>
    <time_frame>NPI assessments during DB treatment period, Baseline and Week 6</time_frame>
    <description>The NPI is a 12-item behavior rating scale composed of a structured interview of the caregiver, which assesses psychiatric disturbance. For each subdomain, both the frequency (0 to 3 scale) and the severity (0 to 4 scale) of symptoms is determined. Higher scores represent a worse outcome. The subdomain score is the product of these two measures and ranges from 0 to 12. The combined NPI score is obtained by summing all 12 sub-domain scores and therefore ranges from 0 to 144.&#xD;
Analysis Method: Mixed Model Repeated Measures (MMRM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Double-blind (DB) Baseline in Mini Mental State Evaluation (MMSE) at Week 6</measure>
    <time_frame>MMSE assessments during DB treatment period, Baseline and Week 6</time_frame>
    <description>The Mini Mental State Examination (MMSE) for Cognition is a brief instrument, used to assess cognitive function, consisting of 11 tests including orientation, memory (recent and immediate), concentration, language, and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. MMSE, the total score is the sum of all 11 tests.&#xD;
Analysis Method: Mixed Model Repeated Measures (MMRM)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Parkinson Disease Psychosis</condition>
  <arm_group>
    <arm_group_label>SEP-363856</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SEP-363856 (25, 50, or 75mg/day), once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SEP-363856</intervention_name>
    <description>SEP-363856 (25, 50, or 75mg/day)</description>
    <arm_group_label>SEP-363856</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo capsule</intervention_name>
    <description>Placebo once daily</description>
    <arm_group_label>Placebo Capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject, caregiver, and/or legally authorized representative understands and is&#xD;
             willing to sign informed consent to participate in the study.&#xD;
&#xD;
          -  Subject must be willing and able to comply with the study procedures and visit&#xD;
             schedules and must be able to follow verbal and written instructions.&#xD;
&#xD;
          -  Subject is male or postmenopausal female ≥ 55 years of age.&#xD;
&#xD;
          -  Subject meets established diagnostic criteria for Parkinson's disease of at least one&#xD;
             year duration, consistent with the UK Brain Bank criteria&#xD;
&#xD;
          -  Subject has psychotic symptoms that began after the diagnosis of PD for at least one&#xD;
             month, occurring at least weekly in the month prior to screening (according to subject&#xD;
             or caregiver), and severe enough to warrant treatment with antipsychotics.&#xD;
&#xD;
          -  Subject has a combined score of at least 6 or an individual score of at least 4 on the&#xD;
             neuropsychiatric inventory (NPI) Item A (delusions) and/or Item B (hallucinations).&#xD;
             This crieterion must be met at Visit 1 and Visit 3.&#xD;
&#xD;
          -  Subject has a Mini-mental status examination (MMSE) score &gt; 21 points out of 30.&#xD;
&#xD;
          -  Subject has a caregiver (spouse or family member) who will be required to attend all&#xD;
             visits and is able to provide study information on various scales such as the NPI.&#xD;
&#xD;
          -  Subject is taking antiparkinsonian drugs or deep brain stimulation, with a stable&#xD;
             dose/dose regimen and settings for 3 months before enrolment.&#xD;
&#xD;
          -  Female subject must be postmenopausal defined as being amenorrheic for greater than&#xD;
             two years with an appropriate clinical profile.&#xD;
&#xD;
          -  Male subjects with female partner(s) of childbearing potential must agree to avoid&#xD;
             fathering a child and use acceptable methods of birth control from screening until at&#xD;
             least 30 days after the last study drug administration.&#xD;
&#xD;
          -  Subject is, in the opinion of the Investigator, medically stable based on screening&#xD;
             medical history, PE, neurological examination, vital signs, clinical laboratory values&#xD;
             (hematology, serum chemistry, urinalysis, lipid panel, coagulation panel, thyroid&#xD;
             panel, and serum prolactin).&#xD;
&#xD;
          -  Subject has had a stable living arrangement at the time of screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has psychosis secondary to other toxic or metabolic disorders.&#xD;
&#xD;
          -  Subject has atypical Parkinson's disease, Parkinsonism secondary to medication or&#xD;
             other neurodegenerative disorders, such as progressive supranuclear palsy or multiple&#xD;
             system atrophy.&#xD;
&#xD;
          -  Subject has dementia diagnosed concurrent with or before Parkinson's disease, motor&#xD;
             symptoms that began less than one year before the onset of dementia or symptoms&#xD;
             consistent with the diagnosis of lewy body dementia (LBD), or if the psychosis&#xD;
             occurred after ablative stereotaxic surgery.&#xD;
&#xD;
          -  Subject failed 2 or more antipsychotic agents given at adequate doses for at least 4&#xD;
             weeks within 1 year before screening.&#xD;
&#xD;
          -  Subject has had a stroke or other uncontrolled serious medical or neurological illness&#xD;
             within 6 months of baseline.&#xD;
&#xD;
          -  Subject answers &quot;yes&quot; to &quot;Suicidal Ideation&quot; Item 4 (active suicidal ideation with&#xD;
             some intent to act, without specific plan) or Item 5 (active suicidal ideation with&#xD;
             specific plan and intent) on the C SSRS at Screening (ie, in the past one month), or&#xD;
             baseline (ie, since last visit).&#xD;
&#xD;
          -  Subject does not tolerate venipuncture or has poor venous access that would cause&#xD;
             difficulty for collecting blood samples.&#xD;
&#xD;
          -  Subject has participated in an investigational drug study and received investigational&#xD;
             drug within 30 days (or longer if the half-life is known to be ≥ 150 hours) prior to&#xD;
             the screening visit, or who is currently participating in another clinical study.&#xD;
             Subject has previously received SEP 363856.&#xD;
&#xD;
          -  Subject has any clinically significant unstable medical condition or any clinically&#xD;
             significant chronic disease that in the opinion of the Investigator, would limit the&#xD;
             subject's ability to complete and/or participate in the study:&#xD;
&#xD;
          -  Subject has hematological (including deep vein thrombosis) or bleeding disorder,&#xD;
             renal, metabolic, endocrine, pulmonary, gastrointestinal, urological, cardiovascular,&#xD;
             hepatic, neurologic, or allergic disease that is clinically significant or unstable&#xD;
             (except for untreated, asymptomatic, seasonal allergies at time of dosing).&#xD;
&#xD;
          -  Subject has a history of cancer or significant neoplasm.&#xD;
&#xD;
          -  Subject has a disorder or history of a condition or previous gastrointestinal surgery&#xD;
             (eg, cholecystectomy, vagotomy, bowel resection, or any surgical procedure) that may&#xD;
             interfere with drug absorption, distribution, metabolism, excretion, gastrointestinal&#xD;
             motility, or pH, or a clinically significant abnormality of the hepatic or renal&#xD;
             system, or a history of malabsorption.&#xD;
&#xD;
          -  Subject has Alcohol or Substance Abuse Disorder (DSM 5 criteria). The only exceptions&#xD;
             are caffeine or nicotine.&#xD;
&#xD;
          -  Subject has a clinically significant abnormal 12 lead ECG that may jeopardize the&#xD;
             subject's ability to complete the study or a screening 12 lead ECG demonstrating any&#xD;
             one of the following: heart rate &gt; 100 beats per minute, QRS &gt; 120 ms, QT interval&#xD;
             corrected for heart rate using Fridericia's formula (QTcF) &gt; 450 ms (males), QTcF &gt;&#xD;
             470 ms (females), or PR &gt; 220 ms.&#xD;
&#xD;
          -  Subjects with known human immunodeficiency virus (HIV) seropositivity will be&#xD;
             excluded.&#xD;
&#xD;
          -  Female subject who is pregnant or lactating.&#xD;
&#xD;
          -  Subject has a presence or history of a medically diagnosed, clinically significant&#xD;
             psychiatric disorder.&#xD;
&#xD;
          -  Subject is at significant risk of harming him/herself or others according to the&#xD;
             Investigator's judgment.&#xD;
&#xD;
          -  Subject has attempted suicide within 3 months prior to screening.&#xD;
&#xD;
          -  Subject has a history of allergic reaction or suspected sensitivity to any substance&#xD;
             that is contained in the formulation.&#xD;
&#xD;
          -  Subject has any clinically significant abnormal laboratory values (hematology, serum&#xD;
             chemistry, urinalysis, lipid panel, coagulation panel, thyroid panel, serum prolactin,&#xD;
             and urine drug screen(Note: abnormal findings that may be clinically significant or of&#xD;
             questionable significance will be discussed with the Medical Monitor prior to&#xD;
             including subject).&#xD;
&#xD;
          -  Subjects with serum alanine transaminase (ALT) or aspartate transaminase (AST) levels&#xD;
             ≥ 3 times, serum blood urea nitrogen (BUN) or creatine ≥ 1.5 X the upper limit of the&#xD;
             reference ranges provided by the central laboratory require retesting. If on&#xD;
             retesting, the laboratory value remains equal to or above the ULN, the subject will be&#xD;
             excluded.&#xD;
&#xD;
          -  Subjects with a random (non-fasting) blood glucose at screening ≥ 200 mg/dL (11.1&#xD;
             mmol/L) and HbA1c ≥ 6.5% will be excluded.&#xD;
&#xD;
          -  Subject has a prolactin concentration &gt; 100 ng/mL at screening or has a history of&#xD;
             pituitary adenoma.&#xD;
&#xD;
          -  Subject's BMI is ≥ 30 mg/kg/m2.&#xD;
&#xD;
          -  Subject has experienced significant blood loss (≥ 473 mL) or donated blood within 60&#xD;
             days prior to first dose of study drug; has donated plasma within 72 hours prior to&#xD;
             the first dose of study drug or intends to donate plasma or blood or undergo elective&#xD;
             surgery during study participation or within 60 days after the last study visit.&#xD;
&#xD;
          -  Subject consumes more than 300 mg of caffeine per day (5 cups of coffee or equivalent&#xD;
             in caffeinated beverages).&#xD;
&#xD;
          -  Subject has used disallowed prescription medications or anticipates the need for any&#xD;
             disallowed medication during their participation in this study. Subject is a staff&#xD;
             member or the relative of a staff member.&#xD;
&#xD;
          -  Subject is in the opinion of the Investigator, unsuitable in any other way to&#xD;
             participate in this study.&#xD;
&#xD;
        Continuation into Open-label Extension Cirteria&#xD;
&#xD;
          -  Subject must have completed the 6-week double-blind treatment.&#xD;
&#xD;
          -  Subject has not taken any medication other than the study drug for the purpose of&#xD;
             controlling PDD symptoms&#xD;
&#xD;
             . • There has been no clinically significant change in the subject's medical condition&#xD;
             or Parkinson's disease, in the opinion of the investigator.&#xD;
&#xD;
          -  Subject has not answered &quot;yes&quot; to &quot;suicidal ideation&quot; item 4 (active suicidal ideation&#xD;
             with some intent to act, without specific plan) or item 5 (active suicidal ideation&#xD;
             with specific plan and intent) on the C-SSRS assessment at any time during the DB&#xD;
             treatment period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CNS Medical Director</last_name>
    <role>Study Chair</role>
    <affiliation>Sumitomo Pharma America, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Neuuro-Pain Medical Center</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keck School of Medicine of USC/ University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CiTrials</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University Hospial, Research Pharmacy Servcies</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JEM Research Institute</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UHealth at Boca Raton</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkinson's Disease and Movement Disorders Center of Boca Raton</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami, Dept. of Neurology</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Associates of Ormond Beach</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkinson's Disease Treatment Center of Southwest Florida</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33980</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Neuroscience Associates, Inc.</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Parkinson's Disease and Movement Disorder's Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Emory Clinic</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford West Bloomfield Hospital</name>
      <address>
        <city>West Bloomfield</city>
        <state>Michigan</state>
        <zip>48322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brian Maddux</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Movement Disorder Clinic of Oklahoma</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania, Department of Neurology</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Northwest Research</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>April 10, 2023</results_first_submitted>
  <results_first_submitted_qc>May 8, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 5, 2023</results_first_posted>
  <disposition_first_submitted>April 12, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>April 12, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 14, 2021</disposition_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's Disease Psychosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study may be made available upon request via the Vivli Center for Global Clinical Research Data website.</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>IPD will be made available upon request within 12 months of posting the study results on ct.gov.</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>http://vivli.org</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT02969369/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT02969369/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo (QD)</description>
        </group>
        <group group_id="P2">
          <title>SEP-363856</title>
          <description>SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Modified Intent-to-Treat Population</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>WITHDRAWAL BY PI DUE TO OTHER UNDERLYING ILLNESSES</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Double-blind Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14">Not all subjects who completed the Double Blind period, enrolled in the Open Label period.</participants>
                <participants group_id="P2" count="25">Not all subjects who completed the Double Blind period, enrolled in the Open Label period.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Modified Intent-to-Treat Population</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>WITHDRAWAL BY PI DUE TO OTHER UNDERLYING ILLNESSES</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-label SEP-363856 Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7">Not all subjects who completed the Double Blind period, enrolled in the Open Label period.</participants>
                <participants group_id="P2" count="9">Not all subjects who completed the Double Blind period, enrolled in the Open Label period.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo (QD)</description>
        </group>
        <group group_id="B2">
          <title>SEP-363856</title>
          <description>SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)</description>
        </group>
        <group group_id="B3">
          <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="14"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="32"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.8" spread="7.12"/>
                    <measurement group_id="B2" value="70.4" spread="7.31"/>
                    <measurement group_id="B3" value="70.9" spread="7.18"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Native Hawaiian or other Pacific Islander</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&gt;=55 - &lt;65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 - &lt;75 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=75 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Body Mass Index (BMI) (kg/m^2)</title>
          <population>One participant is missing this measurement in the data.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.15" spread="5.239"/>
                    <measurement group_id="B2" value="26.08" spread="4.808"/>
                    <measurement group_id="B3" value="25.42" spread="4.975"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Body Mass Index (BMI) Category</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;18.5 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=18.5 - &lt;25.0 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=25.0 - &lt;30.0 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=30.0 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Scale for Assessment of Positive Symptoms - Parkinson's Disease (SAPS-PD) Total Score</title>
          <description>The SAPS-PD consists of seven items assessing individual symptoms (four items for hallucinations and three items for delusions), a global hallucinations item and a global delusions item. Separate items are rated from 0 (absent) to 5 (severe) so that higher values represent a worse outcome. Total score is equal to the sum of the seven items plus the global hallucinations, plus the global delusions. Therefore a total possible score on the SAPS-PD ranges from 0 to 45.</description>
          <population>One participant is missing this measurement in the data.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.7" spread="8.71"/>
                    <measurement group_id="B2" value="13.3" spread="6.00"/>
                    <measurement group_id="B3" value="13.8" spread="6.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Scale for Assessment of Positive Symptoms - Parkinson's Disease (SAPS-PD) Delusion Subscale</title>
          <description>The SAPS-PD subscale for delusions is defined as the sum of the three items for delusions and the global delusion item. Separate items are rated from 0 (absent) to 5 (severe) so that higher values represent a worse outcome, with a range of 0 to 20.</description>
          <population>One participant is missing this measurement in the data.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.7" spread="3.95"/>
                    <measurement group_id="B2" value="3.0" spread="4.18"/>
                    <measurement group_id="B3" value="2.9" spread="4.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Scale for Assessment of Positive Symptoms - Parkinson's (SAPS-PD) Hallucination Subscale</title>
          <description>The SAPS-PD subscale for hallucinations is defined as the sum of the 4 items for hallucinations and the global hallucination item. Separate items are rated from 0 (absent) to 5 (severe) so that higher values represent a worse outcome, with a range of 0 to 25.</description>
          <population>One participant is missing this measurement in the data.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.0" spread="6.60"/>
                    <measurement group_id="B2" value="10.3" spread="4.54"/>
                    <measurement group_id="B3" value="10.9" spread="5.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Double Blind (DB) Baseline in Total Scale for Assessment of Positive Symptoms - Parkinson's Disease ( SAPS-PD) Score at Week 6</title>
        <description>There are seven items assessing individual symptoms (four items for hallucinations and three items for delusions), a global hallucinations item and a global delusions item. Separate items are rated from 0 (absent) to 5 (severe), so that higher values represent a worse outcome. Total score is equal to the sum of the seven items plus the global hallucinations, plus the global delusions. Therefore a total possible score on the SAPS-PD ranges from 0 to 45.&#xD;
The primary analysis of the primary efficacy variable will use a mixed model for repeated measures (MMRM).</description>
        <time_frame>SAPS-PD assessments during DB treatment period, Baseline and Week 6</time_frame>
        <population>The modified intention-to-treat (mITT) population is defined as all subjects who were randomized, received at least one dose of study drug, and had a baseline and at least one post-baseline total score in SAPS-PD or NPI or CGI-S during the DB treatment period.&#xD;
The mITT population is the primary population for the efficacy analyses. Subjects are analyzed according to randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (QD)</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Double Blind (DB) Baseline in Total Scale for Assessment of Positive Symptoms - Parkinson's Disease ( SAPS-PD) Score at Week 6</title>
          <description>There are seven items assessing individual symptoms (four items for hallucinations and three items for delusions), a global hallucinations item and a global delusions item. Separate items are rated from 0 (absent) to 5 (severe), so that higher values represent a worse outcome. Total score is equal to the sum of the seven items plus the global hallucinations, plus the global delusions. Therefore a total possible score on the SAPS-PD ranges from 0 to 45.&#xD;
The primary analysis of the primary efficacy variable will use a mixed model for repeated measures (MMRM).</description>
          <population>The modified intention-to-treat (mITT) population is defined as all subjects who were randomized, received at least one dose of study drug, and had a baseline and at least one post-baseline total score in SAPS-PD or NPI or CGI-S during the DB treatment period.&#xD;
The mITT population is the primary population for the efficacy analyses. Subjects are analyzed according to randomized treatment group.</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="13"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" lower_limit="-5.6" upper_limit="2.8"/>
                    <measurement group_id="O2" value="-2.5" lower_limit="-5.8" upper_limit="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Double Blind (DB) Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) at Week 6.</title>
        <description>The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.&#xD;
Analysis Method: Mixed Model Repeated Measures (MMRM)</description>
        <time_frame>CGI-S assessments during DB treatment period, Baseline and Week 6</time_frame>
        <population>The modified intention-to-treat (mITT) population is defined as all subjects who were randomized, received at least one dose of study drug, and had a baseline and at least one post-baseline total score in SAPS-PD or NPI or CGI-S during the DB treatment period.&#xD;
The mITT population is the primary population for the efficacy analyses. Subjects are analyzed according to randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (QD)</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Double Blind (DB) Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) at Week 6.</title>
          <description>The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.&#xD;
Analysis Method: Mixed Model Repeated Measures (MMRM)</description>
          <population>The modified intention-to-treat (mITT) population is defined as all subjects who were randomized, received at least one dose of study drug, and had a baseline and at least one post-baseline total score in SAPS-PD or NPI or CGI-S during the DB treatment period.&#xD;
The mITT population is the primary population for the efficacy analyses. Subjects are analyzed according to randomized treatment group.</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="14"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" lower_limit="-1.5" upper_limit="0.1"/>
                    <measurement group_id="O2" value="-0.4" lower_limit="-1.1" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Double Blind (DB) Baseline in Neuropsychiatric Inventory (NPI) at Week 6</title>
        <description>The NPI is a 12-item behavior rating scale composed of a structured interview of the caregiver, which assesses psychiatric disturbance. For each subdomain, both the frequency (0 to 3 scale) and the severity (0 to 4 scale) of symptoms is determined. Higher scores represent a worse outcome. The subdomain score is the product of these two measures and ranges from 0 to 12. The combined NPI score is obtained by summing all 12 sub-domain scores and therefore ranges from 0 to 144.&#xD;
Analysis Method: Mixed Model Repeated Measures (MMRM)</description>
        <time_frame>NPI assessments during DB treatment period, Baseline and Week 6</time_frame>
        <population>The modified intention-to-treat (mITT) population is defined as all subjects who were randomized, received at least one dose of study drug, and had a baseline and at least one post-baseline total score in SAPS-PD or NPI or CGI-S during the DB treatment period. The mITT population is the primary population for the efficacy analyses. Subjects are analyzed according to randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (QD)</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Double Blind (DB) Baseline in Neuropsychiatric Inventory (NPI) at Week 6</title>
          <description>The NPI is a 12-item behavior rating scale composed of a structured interview of the caregiver, which assesses psychiatric disturbance. For each subdomain, both the frequency (0 to 3 scale) and the severity (0 to 4 scale) of symptoms is determined. Higher scores represent a worse outcome. The subdomain score is the product of these two measures and ranges from 0 to 12. The combined NPI score is obtained by summing all 12 sub-domain scores and therefore ranges from 0 to 144.&#xD;
Analysis Method: Mixed Model Repeated Measures (MMRM)</description>
          <population>The modified intention-to-treat (mITT) population is defined as all subjects who were randomized, received at least one dose of study drug, and had a baseline and at least one post-baseline total score in SAPS-PD or NPI or CGI-S during the DB treatment period. The mITT population is the primary population for the efficacy analyses. Subjects are analyzed according to randomized treatment group.</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="14"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.3" lower_limit="-28.3" upper_limit="-6.2"/>
                    <measurement group_id="O2" value="-11.5" lower_limit="-20.2" upper_limit="-2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Double-blind (DB) Baseline in Mini Mental State Evaluation (MMSE) at Week 6</title>
        <description>The Mini Mental State Examination (MMSE) for Cognition is a brief instrument, used to assess cognitive function, consisting of 11 tests including orientation, memory (recent and immediate), concentration, language, and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. MMSE, the total score is the sum of all 11 tests.&#xD;
Analysis Method: Mixed Model Repeated Measures (MMRM)</description>
        <time_frame>MMSE assessments during DB treatment period, Baseline and Week 6</time_frame>
        <population>The modified intention-to-treat (mITT) population is defined as all subjects who were randomized, received at least one dose of study drug, and had a baseline and at least one post-baseline total score in SAPS-PD or NPI or CGI-S during the DB treatment period. The mITT population is the primary population for the efficacy analyses. Subjects are analyzed according to randomized treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (QD)</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Double-blind (DB) Baseline in Mini Mental State Evaluation (MMSE) at Week 6</title>
          <description>The Mini Mental State Examination (MMSE) for Cognition is a brief instrument, used to assess cognitive function, consisting of 11 tests including orientation, memory (recent and immediate), concentration, language, and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. MMSE, the total score is the sum of all 11 tests.&#xD;
Analysis Method: Mixed Model Repeated Measures (MMRM)</description>
          <population>The modified intention-to-treat (mITT) population is defined as all subjects who were randomized, received at least one dose of study drug, and had a baseline and at least one post-baseline total score in SAPS-PD or NPI or CGI-S during the DB treatment period. The mITT population is the primary population for the efficacy analyses. Subjects are analyzed according to randomized treatment group.</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="14"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="-0.9" upper_limit="1.4"/>
                    <measurement group_id="O2" value="-0.8" lower_limit="-1.7" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse events (AEs) during the 6-week DB and 12-week OL periods by actual treatment group.</time_frame>
      <desc>An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occur after first administration of study drug are considered AEs.&#xD;
Results presented are for DB + OL periods combined (all study AEs). AE counts are displayed according to the actual treatment the subject was on at the time of the event.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo (QD)</description>
        </group>
        <group group_id="E2">
          <title>SEP-363856</title>
          <description>SEP-363856 (25, 50, or 75 mg/day flexible dosing QD)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</default_vocab>
        <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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</default_vocab>
        <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="12" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Corneal abrasion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="10" subjects_affected="6" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Aggression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Delusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Disorientation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hallucination, auditory</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
              </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>In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>CNS Medical Director</name_or_title>
      <organization>Sunovion Pharmaceuticals Inc.</organization>
      <phone>1-866-503-6351</phone>
      <email>clinicaltraildisclosure@sunovion.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/NCT02969369
org study id: SEP361-203
nct id: NCT02969369
lead sponsor: 
has dmc: No
A study to evaluate the safety and tolerability of SEP-363856 in subjects with Parkinson's
      Disease Psychosis. This study is accepting male and female participants 55 years of age and
      older who have been diagnosed with Parkinson's Disease. This study will be conducted in 24
      study centers in the United States.

      The study will last approximately 21 weeks.
This is a multicenter, randomized, parallel-group, placebo-controlled study evaluating the
      efficacy, safety, and tolerability of double-blind SEP-363856 flexibly dosed at 25, 50, or 75
      mg/day for 6 weeks followed by 12 weeks of open-label extension of SEP-363856 flexibly-dosed
      at 25, 50, or 75 mg/day in male and female subjects ≥ 55 years of age with a clinical
      diagnosis of PDP. The study will randomize approximately 36 subjects to 2 treatment groups in
      a 2:1 ratio (approximately 24 subjects to SEP-363856 and 12 to placebo). The study will
      consist of 4 periods: Screening/Washout Period (up to 14 days prior to Double-blind
      Treatment), Double-blind Treatment Period (6 weeks), Open-label SEP-363856 Treatment Period
      (12 weeks), and Follow-up Period (1 week after last dose) as shown in the following figure.
      All postBaseline clinic visits will have a window of ± 2 days relative to the date of the
      Baseline visit (Visit 3).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Double Blind (DB) Baseline in Total Scale for Assessment of Positive Symptoms - Parkinson's Disease ( SAPS-PD) Score at Week 6
time frame: SAPS-PD assessments during DB treatment period, Baseline and Week 6
description: There are seven items assessing individual symptoms (four items for hallucinations and three items for delusions), a global hallucinations item and a global delusions item. Separate items are rated from 0 (absent) to 5 (severe), so that higher values represent a worse outcome. Total score is equal to the sum of the seven items plus the global hallucinations, plus the global delusions. Therefore a total possible score on the SAPS-PD ranges from 0 to 45.
The primary analysis of the primary efficacy variable will use a mixed model for repeated measures (MMRM).
measure: Change From Double Blind (DB) Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) at Week 6.
time frame: CGI-S assessments during DB treatment period, Baseline and Week 6
description: The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.
Analysis Method: Mixed Model Repeated Measures (MMRM)
measure: Change From Double Blind (DB) Baseline in Neuropsychiatric Inventory (NPI) at Week 6
time frame: NPI assessments during DB treatment period, Baseline and Week 6
description: The NPI is a 12-item behavior rating scale composed of a structured interview of the caregiver, which assesses psychiatric disturbance. For each subdomain, both the frequency (0 to 3 scale) and the severity (0 to 4 scale) of symptoms is determined. Higher scores represent a worse outcome. The subdomain score is the product of these two measures and ranges from 0 to 12. The combined NPI score is obtained by summing all 12 sub-domain scores and therefore ranges from 0 to 144.
Analysis Method: Mixed Model Repeated Measures (MMRM)
measure: Change From Double-blind (DB) Baseline in Mini Mental State Evaluation (MMSE) at Week 6
time frame: MMSE assessments during DB treatment period, Baseline and Week 6
description: The Mini Mental State Examination (MMSE) for Cognition is a brief instrument, used to assess cognitive function, consisting of 11 tests including orientation, memory (recent and immediate), concentration, language, and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. MMSE, the total score is the sum of all 11 tests.
Analysis Method: Mixed Model Repeated Measures (MMRM)
arm group label: SEP-363856
arm group type: Experimental
description: SEP-363856 (25, 50, or 75mg/day), once daily
arm group label: Placebo Capsule
arm group type: Placebo Comparator
description: Placebo once daily
intervention type: Drug
intervention name: SEP-363856
description: SEP-363856 (25, 50, or 75mg/day)
arm group label: SEP-363856
intervention type: Drug
intervention name: Placebo capsule
description: Placebo once daily
arm group label: Placebo Capsule
criteria: 
gender: All
minimum age: 55 Years
maximum age: 105 Years
healthy volunteers: No
last name: CNS Medical Director
role: Study Chair
affiliation: Sumitomo Pharma America, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Psychotic Disorders
mesh term: Mental Disorders
sharing ipd: Yes
ipd description: IPD for this study may be made available upon request via the Vivli Center for Global Clinical Research Data website.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD will be made available upon request within 12 months of posting the study results on ct.gov.
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: http://vivli.org
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 