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

  nicola.pavese@newcastle.ac.uk

• 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