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

• Status: Completed
• Trial end date: 2018-09-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intra-Cellular Therapies, Inc.

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