At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 39 enrolled
Drug / intervention
SEP-363856 +1 moredrug
Likely dose
SEP-363856 75mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Nov 21, 2016·Updated Jul 5, 2024
In Brief
A Phase 2 clinical trial evaluating SEP-363856 and Placebo capsule for Parkinson Disease Psychosis. Completed, enrolled 39 participants across 24 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease Psychosis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartDec 2016
Primary CompletionApr 2020
TodayJul 2026
First PostedNov 21, 2016
Enrollment StartDec 31, 2016
Primary CompletionApr 20, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.6 years ago
Interventions
SEP-363856drug
SEP-363856 (25, 50, or 75mg/day)
Placebo capsuledrug
Placebo once daily