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

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

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.

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