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BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

NCT03194217 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2025-03-10

Study results available
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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

Interventions

DRUG

BEN-2001

Bavisant dihydrochloride monohydrate for oral use

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • BenevolentAI Bio

    lead INDUSTRY

Principal Investigators

  • William G Ondo, M.D · Methodist Neurological Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-10
Primary Completion
2019-05-28
Completion
2019-05-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194217 on ClinicalTrials.gov