Skip to main content
OpenTrials
Completed

NCT Number: NCT03194217

BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Excessive Daytime Sleepiness Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disorders of Excessive Somnolence Dyssomnias Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Sleep Disorders, Intrinsic Sleep Wake Disorders Synucleinopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MaxBlue Institute

Miami, Florida, 33018, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BEN-2001

Drug

Bavisant dihydrochloride monohydrate for oral use

Other names: Bavisant

Placebo

Drug

Placebo

Primary outcomes

  1. Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

BenevolentAI Bio

Industry

Registry information

Official study 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).

Acronym: CASPAR

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 21, 2017
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.