BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

• Status: Completed
• Trial end date: 2019-05-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BenevolentAI Bio

Criteria

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.