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: Active, not 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

Find a Site Location and Contact the Trial Team

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

More Inclusion & Exclusion Criteria

Share This Trial

Fox Trial Finder strives to make all trial postings as accurate and complete as possible. If you believe any of the information on this page is not accurate, click here to contact us. Thank you for your support.

Choose your location

Please select a Trial Location.


You have favorited this trial!

This trial will be listed in the "Favorites" category of your dashboard.


You are not interested.

This trial will be listed in the "Not Interested" category on your dashboard. You can click "Interested" if you change your mind.

Message to Trial Coordinator

Your message was sent.

Your message was sent to the trial team at the location you selected. Check your dashboard for a response.

Login to Fox Trial Finder

Please enter your email address and password to access your My Fox Trial Finder dashboard.

*indicates required field.

Contact Fox Trial Finder

What best describes you?

*indicates required field.