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BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness | Clinical Trials | Clareo Health

COMPLETEDPHASE2

BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

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).

NCT03194217•BenevolentAI Bio

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

MaxBlue Institute

Miami, Florida, United States

Key Dates

Start Date

November 10, 2017

Primary Completion Date

May 28, 2019

Completion Date

May 28, 2019

Last Updated

March 10, 2025

Enrollment

244

ACTUAL participants

Conditions

Excessive Daytime SleepinessParkinson Disease

Interventions

BEN-2001

DRUG

Placebo

DRUG

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Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

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