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

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ClinicalTrials.gov Identifier: NCT03257046
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: ITI-214 Other: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
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
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
Actual Study Start Date : September 28, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 mg ITI-214
Administered once daily for 7 days
Drug: ITI-214
Oral

Experimental: 3 mg ITI-214
Administered once daily for 7 days
Drug: ITI-214
Oral

Experimental: 10 mg ITI-214
Administered once daily for 7 days
Drug: ITI-214
Oral

Experimental: 30 mg ITI-214
Administered once daily for 7 days
Drug: ITI-214
Oral

Placebo Comparator: Placebo
Administered once daily for 7 days
Other: Placebo
Oral




Primary Outcome Measures :
  1. Number of patients with reported or observed treatment-related adverse events [ Time Frame: 7 days ]
    Safety and tolerability


Secondary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: 7 days ]
    Pharmacokinetics

  2. Area of the Curve (AUC) [ Time Frame: 7 days ]
    Pharmacokinetics

  3. Motor and non-motor symptoms as assessed by the MDS-UPDRS [ Time Frame: 7 days ]
    Pharmacodynamics


Other Outcome Measures:
  1. Exploratory biomarkers [ Time Frame: 7 days ]
    Pharmacodynamics



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257046


Contacts
Contact: Kimberly Vanover, PhD 646-440-9333 itciclinicaltrials@intracellulartherapies.com

Locations
United States, Georgia
Atlanta Center for Medical Research Recruiting
Atlanta, Georgia, United States, 30331
United States, North Carolina
Duke Early Phase Research Unit Recruiting
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
Investigators
Study Director: Kimberly Vanover, PhD Intra-Cellular Therapies, Inc.

Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT03257046     History of Changes
Other Study ID Numbers: ITI-214-105
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases