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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03257046
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

Tracking Information
First Submitted Date  ICMJE August 14, 2017
First Posted Date  ICMJE August 22, 2017
Last Update Posted Date December 20, 2018
Actual Study Start Date  ICMJE September 28, 2017
Actual Primary Completion Date September 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
Number of patients with reported or observed treatment-related adverse events [ Time Frame: 7 days ]
Safety and tolerability
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
  • Maximum Plasma Concentration (Cmax) [ Time Frame: 7 days ]
    Pharmacokinetics
  • Area of the Curve (AUC) [ Time Frame: 7 days ]
    Pharmacokinetics
  • Motor and non-motor symptoms as assessed by the MDS-UPDRS [ Time Frame: 7 days ]
    Pharmacodynamics
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 26, 2017)
Exploratory biomarkers [ Time Frame: 7 days ]
Pharmacodynamics
Original Other Pre-specified Outcome Measures
 (submitted: August 17, 2017)
Exploratory biomarkers [ Time Frame: 7 days ]
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: ITI-214
    Oral
  • Other: Placebo
    Oral
Study Arms  ICMJE
  • Experimental: 1 mg ITI-214
    Administered once daily for 7 days
    Intervention: Drug: ITI-214
  • Experimental: 3 mg ITI-214
    Administered once daily for 7 days
    Intervention: Drug: ITI-214
  • Experimental: 10 mg ITI-214
    Administered once daily for 7 days
    Intervention: Drug: ITI-214
  • Experimental: 30 mg ITI-214
    Administered once daily for 7 days
    Intervention: Drug: ITI-214
  • Experimental: 90 mg ITI-214
    Administered once daily for 7 days
    Intervention: Drug: ITI-214
  • Placebo Comparator: Placebo
    Administered once daily for 7 days
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2018)
40
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2017)
24
Actual Study Completion Date  ICMJE September 28, 2018
Actual Primary Completion Date September 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Major Inclusion Criteria:

  • Clinical diagnosis of idiopathic Parkinson's disease (PD)
  • Severity of PD assessed by Hoehn and Yahr Staging score of 1 to 3
  • Maintenance on stable PD therapy

Major Exclusion Criteria:

  • Clinical signs of dementia
  • Suicidal ideation or behavior
  • Considered medically inappropriate for study participation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03257046
Other Study ID Numbers  ICMJE ITI-214-105
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Intra-Cellular Therapies, Inc.
Study Sponsor  ICMJE Intra-Cellular Therapies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kimberly Vanover, PhD Intra-Cellular Therapies, Inc.
PRS Account Intra-Cellular Therapies, Inc.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP