Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease
Lead Sponsor:
Intra-Cellular Therapies, Inc.
Conditions:
Parkinson Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
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, pharmaco...
Eligibility Criteria
Inclusion
- Major
- 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
- Clinical signs of dementia
- Suicidal ideation or behavior
- Considered medically inappropriate for study participation
Key Trial Info
Start Date :
September 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03257046
Start Date
September 28 2017
End Date
September 28 2018
Last Update
December 20 2018
Active Locations (2)
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1
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
2
Duke Early Phase Research Unit
Durham, North Carolina, United States, 27708