NCT02969369

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

A Multicenter Randomized Double-blind Followed by an Open-label Extension Study to Evaluate the Efficacy, Safety, and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 55 Years – 105 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the safety and tolerability of SEP-363856 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 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).

Conditions

• Parkinson Disease Psychosis

Interventions

Type	Name	Description
DRUG	SEP-363856	SEP-363856 (25, 50, or 75mg/day)
DRUG	Placebo capsule	Placebo once daily

Timeline

• Start date: 2016-12-31
• Primary completion: 2020-04-20
• Completion: 2020-04-20
• First posted: 2016-11-21
• Last updated: 2024-07-05
• Results posted: 2023-06-05

Locations

24 sites across 1 country: United States