Title
BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
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).
Phase
Phase 2Lead Sponsor
BenevolentAI BioStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Excessive Daytime Sleepiness Parkinson DiseaseIntervention/Treatment
bavisant ...Study Participants
244This 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.
Phase 2b study will be conducted with the aim of investigating the efficacy and safety of three fixed doses of Bavisant (0.5, 1 and 3 mg/d) compared to placebo for the treatment of excessive daytime sleepiness (EDS) in subjects with Parkinson's disease.
Bavisant dihydrochloride monohydrate for oral use
Placebo
Inclusion Criteria: Subjects of either sex aged 50 to 80 years *Subjects with previous diagnosis of Parkinson's disease (following the UK Parkinson's disease society brain bank clinical diagnostic criteria)* Subjects capable of understanding and complying with protocol requirements Subjects with medical history of excessive daytime sleepiness Exclusion Criteria: Subjects with excessive daytime sleepiness due to conditions other than Parkinson's disease (including narcolepsy) Subjects with clinical evidence of depression with significant psychiatric comorbidities (Hamilton Rating Scale for Depression - HAM-D score greater than or equal to 17; with or without treatment) Subjects with evidence of significant fatigue (Fatigue Severity Scale - FSS greater than or equal to 36 Subjects with known history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion. Subjects with known allergies or hypersensitivity to Bavisant or any of its excipients. Subjects who are pregnant or lactating.
| Event Type | Organ System | Event Term | Placebo | BEN-2001, 0.5mg | BEN-2001, 1.0mg | BEN-2001, 3.0mg |
|---|
Mean absolute change of Bavisant treatment groups in the Epworth Sleepiness Scale (ESS) from baseline to the end of the 6-week treatment period. The ESS score (sum of 8 item scores) ranges from 0 to 24 with higher score corresponding to higher average sleep propensity in daily life (higher daytime sleepiness). Eligibility determined based on ESS score of 13 and above.
