BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness (CASPAR)

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).

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Excessive Daytime Sleepiness
• Intervention / Treatment: Drug: Placebo; Drug: BEN-2001

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 Type: Interventional
• Enrollment (Actual): 244
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33018
      • Maxblue Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo comparator	Drug: Placebo; Placebo
Experimental: BEN-2001, 0.5mg; Experimental treatment	Drug: BEN-2001; Bavisant dihydrochloride monohydrate for oral use; Other Names: Bavisant
Experimental: BEN-2001, 1.0mg; Experimental treatment	Drug: BEN-2001; Bavisant dihydrochloride monohydrate for oral use; Other Names: Bavisant
Experimental: BEN-2001, 3.0mg; Experimental treatment	Drug: BEN-2001; Bavisant dihydrochloride monohydrate for oral use; Other Names: Bavisant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.	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.	6 weeks

Collaborators and Investigators

• Sponsor: BenevolentAI Bio
• Investigators: Principal Investigator: William G Ondo, M.D, Methodist Neurological Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2017
• Primary Completion (Actual): May 28, 2019
• Study Completion (Actual): May 28, 2019

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Disorders of Excessive Somnolence; Sleepiness
• Other Study ID Numbers: BB-2001-201b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No