At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 244 enrolled
Drug / intervention
BEN-2001 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
- ✓Age 50–80 years
- ✓Confirmed Parkinson's disease diagnosis per UK Parkinson's disease society brain bank clinical diagnostic criteria
- ✓Medical history of excessive daytime sleepiness
- ✓Capable of understanding and complying with protocol requirements
Key exclusion· 6
- ✕EDS due to causes other than Parkinson's disease, including narcolepsy
- ✕Clinical evidence of depression with significant psychiatric comorbidities (HAM-D score ≥17)
- ✕Evidence of significant fatigue (FSS ≥36)
- ✕History of alcohol or other substance abuse in the 6 months prior to inclusion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Dose Finding Phase IIb Study of Bavisant to Evaluate Its Safety and effiCacy in treAtment of exceSsive Daytime sleePiness (EDS) in PARkinson's Disease (PD).
In Brief
A Phase 2 clinical trial evaluating BEN-2001 and Placebo for Excessive Daytime Sleepiness and Parkinson Disease. Completed, enrolled 244 participants across 1 site.
Detailed Summary
This phase 2b study is designed as multicentre, multinational, randomized, double blind, parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in subjects with excessive daytime sleepiness with Parkinson's disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExcessive Daytime Sleepiness, Parkinson Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 2017
Enrollment StartNov 2017
Primary CompletionMay 2019
TodayJul 2026
First PostedJun 21, 2017
Enrollment StartNov 10, 2017
Primary CompletionMay 28, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.0 years ago
Interventions
BEN-2001drug
Bavisant dihydrochloride monohydrate for oral use
Placebodrug
Placebo