Parkinson Disease
Conditions
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.
Interventions
DRUGITI-214
Oral
OTHERPlacebo
Oral
Sponsors
Intra-Cellular Therapies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multiple rising dose in sequential cohorts of 8 patients randomized in a 6:2 ratio to receive ITI-214 or placebo
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with reported or observed treatment-related adverse events | 7 days | Safety and tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area of the Curve (AUC) | 7 days | Pharmacokinetics |
| Maximum Plasma Concentration (Cmax) | 7 days | Pharmacokinetics |
| Motor and non-motor symptoms as assessed by the MDS-UPDRS | 7 days | Pharmacodynamics |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory biomarkers | 7 days | Pharmacodynamics |
Countries
United States
Outcome results
None listed