<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/NCT03257046</url>
  </required_header>
  <id_info>
    <org_study_id>ITI-214-105</org_study_id>
    <nct_id>NCT03257046</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease</brief_title>
  <official_title>A Randomized, Placebo-Controlled, Double-Blind Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ITI-214 in Patients With Idiopathic Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intra-Cellular Therapies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intra-Cellular Therapies, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase I/II randomized, double-blind, placebo-controlled, multiple rising dose study&#xD;
      in patients with stable idiopathic Parkinson's disease (PD) to evaluate the safety,&#xD;
      tolerability, pharmacokinetics and pharmacodynamics of ITI-214.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">September 28, 2018</completion_date>
  <primary_completion_date type="Actual">September 6, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Multiple rising dose in sequential cohorts of 8 patients randomized in a 6:2 ratio to receive ITI-214 or placebo</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with reported or observed treatment-related adverse events</measure>
    <time_frame>7 days</time_frame>
    <description>Safety and tolerability</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax)</measure>
    <time_frame>7 days</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area of the Curve (AUC)</measure>
    <time_frame>7 days</time_frame>
    <description>Pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor and non-motor symptoms as assessed by the MDS-UPDRS</measure>
    <time_frame>7 days</time_frame>
    <description>Pharmacodynamics</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory biomarkers</measure>
    <time_frame>7 days</time_frame>
    <description>Pharmacodynamics</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>1 mg ITI-214</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered once daily for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 mg ITI-214</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered once daily for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 mg ITI-214</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered once daily for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 mg ITI-214</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered once daily for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>90 mg ITI-214</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered once daily for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administered once daily for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ITI-214</intervention_name>
    <description>Oral</description>
    <arm_group_label>1 mg ITI-214</arm_group_label>
    <arm_group_label>10 mg ITI-214</arm_group_label>
    <arm_group_label>3 mg ITI-214</arm_group_label>
    <arm_group_label>30 mg ITI-214</arm_group_label>
    <arm_group_label>90 mg ITI-214</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Major Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of idiopathic Parkinson's disease (PD)&#xD;
&#xD;
          -  Severity of PD assessed by Hoehn and Yahr Staging score of 1 to 3&#xD;
&#xD;
          -  Maintenance on stable PD therapy&#xD;
&#xD;
        Major Exclusion Criteria:&#xD;
&#xD;
          -  Clinical signs of dementia&#xD;
&#xD;
          -  Suicidal ideation or behavior&#xD;
&#xD;
          -  Considered medically inappropriate for study participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kimberly Vanover, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Intra-Cellular Therapies, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Atlanta Center for Medical Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Early Phase Research Unit</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03257046
org study id: ITI-214-105
nct id: NCT03257046
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase I/II randomized, double-blind, placebo-controlled, multiple rising dose study
      in patients with stable idiopathic Parkinson's disease (PD) to evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of ITI-214.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multiple rising dose in sequential cohorts of 8 patients randomized in a 6:2 ratio to receive ITI-214 or placebo
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of patients with reported or observed treatment-related adverse events
time frame: 7 days
description: Safety and tolerability
measure: Maximum Plasma Concentration (Cmax)
time frame: 7 days
description: Pharmacokinetics
measure: Area of the Curve (AUC)
time frame: 7 days
description: Pharmacokinetics
measure: Motor and non-motor symptoms as assessed by the MDS-UPDRS
time frame: 7 days
description: Pharmacodynamics
measure: Exploratory biomarkers
time frame: 7 days
description: Pharmacodynamics
arm group label: 1 mg ITI-214
arm group type: Experimental
description: Administered once daily for 7 days
arm group label: 3 mg ITI-214
arm group type: Experimental
description: Administered once daily for 7 days
arm group label: 10 mg ITI-214
arm group type: Experimental
description: Administered once daily for 7 days
arm group label: 30 mg ITI-214
arm group type: Experimental
description: Administered once daily for 7 days
arm group label: 90 mg ITI-214
arm group type: Experimental
description: Administered once daily for 7 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Administered once daily for 7 days
intervention type: Drug
intervention name: ITI-214
description: Oral
arm group label: 1 mg ITI-214
arm group label: 10 mg ITI-214
arm group label: 3 mg ITI-214
arm group label: 30 mg ITI-214
arm group label: 90 mg ITI-214
intervention type: Other
intervention name: Placebo
description: Oral
arm group label: Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Kimberly Vanover, PhD
role: Study Director
affiliation: Intra-Cellular Therapies, Inc.
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease