NCT03194217

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).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: BenevolentAI Bio · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Excessive Daytime Sleepiness
• Parkinson Disease

Interventions

Type	Name	Description
DRUG	BEN-2001	Bavisant dihydrochloride monohydrate for oral use
DRUG	Placebo	Placebo

Timeline

• Start date: 2017-11-10
• Primary completion: 2019-05-28
• Completion: 2019-05-28
• First posted: 2017-06-21
• Last updated: 2025-03-10
• Results posted: 2020-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study