Phase 2
N=244
BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
Excessive Daytime Sleepiness · Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT03194217 ↗Enrolled (actual)
244
Serious AEs
1.2%
Results posted
Nov 2020
Primary outcome: Primary: Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose. — -4.34; -4.64; -3.46; -4.73 units on a scale — p=0.668
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BEN-2001 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- BenevolentAI Bio
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose. |
-4.34; -4.64; -3.46; -4.73 | 0.668 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03194217). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.