BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

NCT03194217 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BB-2001-201b
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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.

Conditions

Excessive Daytime Sleepiness; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

BEN-2001, 0.5mg

EXPERIMENTAL

Experimental treatment

Drug: BEN-2001

Placebo

PLACEBO COMPARATOR

Placebo comparator

Drug: Placebo

BEN-2001, 1.0mg

EXPERIMENTAL

Experimental treatment

Drug: BEN-2001

BEN-2001, 3.0mg

EXPERIMENTAL

Experimental treatment

Drug: BEN-2001

Interventions

BEN-2001 DRUG

Bavisant dihydrochloride monohydrate for oral use

Also known as: Bavisant

BEN-2001, 0.5mg; BEN-2001, 1.0mg; BEN-2001, 3.0mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 allergies or hypersensitivity to Bavisant or any of its excipients.
• Subjects who are pregnant or lactating.

Sponsors & Collaborators

• BenevolentAI Bio: lead

Study Sites (1)

MaxBlue Institute

Miami, Florida, 33018, United States

Location

MeSH Terms

Conditions

Disorders of Excessive Somnolence; Parkinson Disease

Interventions

bavisant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Administrator
• Organization: BenevolentAI

LondonAdmin@benevolent.ai

+44 20 3781 9360

Study Officials

• William G Ondo, M.D

  Methodist Neurological Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: November 10, 2017
• Primary Completion: May 28, 2019
• Study Completion: May 28, 2019
• Last Updated: March 10, 2025
• Results First Posted: November 24, 2020

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)