Last updated on November 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 This study is accepting male and female participants 55 years of age and older who have been diagnosed with Parkinson's Disease. This study will be conducted in 24 study centers in the United States. The study will last approximately 21 weeks

Detailed Study Description

This is a multicenter, randomized, parallel-group, placebo-controlled study evaluating the efficacy, safety, and tolerability of double-blind SEP-363856 flexibly dosed at 25, 50, or 75 mg/day for 6 weeks followed by 12 weeks of open-label extension of SEP-363856 flexibly-dosed at 25, 50, or 75 mg/day 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 Double-blind Treatment), Double-blind Treatment Period (6 weeks), Open-label SEP-363856 Treatment Period (12 weeks), and Follow-up Period (1 week after last dose) as shown in the following figure. All postBaseline clinic visits will have a window of 2 days relative to the date of the Baseline visit (Visit 3).

Treatment with SEP-363856 in subjects with PDP will result in a significant reduction in the Scale for Assessment of Positive Symptoms - Parkinson's Disease (SAPS-PD) total score at Week 6 when compared to placebo. Let SEP and PBO represent the mean changes from Baseline at Week 6 in SAPS-PD total score for the SEP-363856 and placebo arms, respectively. The following hypothesis will be tested to compare the mean change values between the SEP-363856 group and placebo group at Week 6: H0: SEP = PBO versus H1: SEP PBO

Clinical Study Identifier: NCT02969369

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