Last updated on February 2019

A Study to Evaluate the Efficacy Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis

Brief description of study

A study to evaluate the safety and tolerability of SEP363856 in subjects with Parkinson's Disease Psychosis

Detailed Study Description

This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of SEP-363856 flexibly dosed at 25, 50, or 75 mg/day for 6 weeks in male and female subjects 55 years of age with a clinical diagnosis of PDP. The study will randomize approximately 36 subjects to 2 treatment groups in a 2:1 ratio (approximately 24 subjects to SEP-363856 and 12 to placebo).

The study will consist of 4 periods: Screening/washout Period (up to 14 days prior to Lead-in), Lead-in Period (2 weeks prior to Baseline), Double-blind treatment Period (6 weeks), and Follow-up Period (1 week after last dose) as shown in the following figure. All post-Baseline clinic visits will have a window of 2 days relative to the date of the Baseline visit (Visit 3).

Clinical Study Identifier: NCT02969369

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Neuuro-Pain Medical Center

Fresno, CA United States
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Recruitment Status: Open

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