NCT03257046
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- ITI-214
- Conditions
- Parkinson Disease
- Sponsor
- Intra-Cellular Therapies, Inc.
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Number of patients with reported or observed treatment-related adverse events
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •Clinical signs of dementia
- •Suicidal ideation or behavior
- •Considered medically inappropriate for study participation
Arms & Interventions
1 mg ITI-214
Administered once daily for 7 days
Intervention: ITI-214
3 mg ITI-214
Administered once daily for 7 days
Intervention: ITI-214
10 mg ITI-214
Administered once daily for 7 days
Intervention: ITI-214
30 mg ITI-214
Administered once daily for 7 days
Intervention: ITI-214
90 mg ITI-214
Administered once daily for 7 days
Intervention: ITI-214
Placebo
Administered once daily for 7 days
Intervention: Placebo
Outcomes
Primary Outcomes
Number of patients with reported or observed treatment-related adverse events
Time Frame: 7 days
Safety and tolerability
Secondary Outcomes
- Maximum Plasma Concentration (Cmax)(7 days)
- Area of the Curve (AUC)(7 days)
- Motor and non-motor symptoms as assessed by the MDS-UPDRS(7 days)
Study Sites (2)
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