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

NCT ID: NCT02969369


Title
A Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of SEP 363856 in Subjects With Parkinson's Disease Psychosis
Purpose
A study to evaluate the safety and tolerability of SEP363856 in subjects with Parkinson's Disease Psychosis
Details
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).
Conditions
Parkinson Disease Psychosis
Keywords
Parkinson's Disease Psychosis
Source
Sunovion
Sponsors
Sunovion
Status
Recruiting
Acronym
Last Updated
09 Jan 2017
URL
Official Link
Locations
United States