Treatment of excessive daytime sleepiness with Bavisant in PD Patients
Research type
Research Study
Full title
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).
IRAS ID
221138
Contact name
Nicola Pavese
Contact email
Sponsor organisation
BenevolentAI Bio
Eudract number
2017-000877-35
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This phase IIb randomized, double blind study will compare the efficacy and safety of three fixed doses of Bavisant (0.5, 1 and 3 mg/day) versus placebo for the treatment of excessive daytime sleepiness (EDS) in subject with Parkinson's disease over a period of 6 weeks of treatment.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0236
Date of REC Opinion
8 Aug 2017
REC opinion
Further Information Favourable Opinion