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

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Interventional
Eligible Ages: 55 - 100 Status: Recruiting
Time Since Diagnosis: Any may be eligible Study Focus:

Study Purpose:

A study to evaluate the safety and tolerability of SEP363856 in subjects with Parkinson's Disease Psychosis To learn more, visit: www.PDPclinicaltrial.com

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More Details

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 post-Baseline clinic visits will have a window of ± 2 days relative to the date of the Baseline visit (Visit 3).

Phase: Phase 2 Lead Sponsor: Sunovion
Trial ID: 004814 Sponsor Type: Industry
Primary Country: United States Additional Collaborators or Sponsors:
Estimated Enrollment: 36 Study Start Date: December 2016
Estimated Study Completion Date: January 2020 Source: ClinicalTrials.gov
Study Website: www.PDPclinicaltrial.com
This is a FDA Regulated Trial

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