BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

Phase 2

Completed

• Conditions: Parkinson Disease; Excessive Daytime Sleepiness
• Interventions: Drug: Placebo; Drug: BEN-2001

• Registration Number: NCT03194217
• Lead Sponsor: BenevolentAI Bio

Brief 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.

Study Timeline

• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-21
• Study Start: 2017-11-10
• Primary Completion: 2019-05-28
• Study Completion: 2019-05-28
• Results First Submitted: 2020-09-02
• Results First Submitted QC: 2020-11-03
• Results First Posted: 2020-11-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo comparator
BEN-2001, 1.0mg	BEN-2001	Experimental treatment
BEN-2001, 3.0mg	BEN-2001	Experimental treatment
BEN-2001, 0.5mg	BEN-2001	Experimental treatment

Primary Outcome Measures

Name	Time	Method
Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.	6 weeks	Mean absolute change of Bavisant treatment groups in the Epworth Sleepiness Scale (ESS) from baseline to the end of the 6-week treatment period.; The ESS score (sum of 8 item scores) ranges from 0 to 24 with higher score corresponding to higher average sleep propensity in daily life (higher daytime sleepiness).; Eligibility determined based on ESS score of 13 and above.

Trial Locations

Locations (1)

MaxBlue Institute; 🇺🇸 Miami, Florida, United States