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A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease

NCT06976268 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2026-01-14

No results posted yet for this study

Summary

A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease.

Conditions

  • Parkinson Disease

Interventions

DRUG

BHV-8000

BHV-8000 10 mg. Participants will take blinded investigational product (IP) once daily

DRUG

BHV-8000

BHV-8000 20 mg. Participants will take blinded investigational product (IP) once daily

DRUG

Placebo

Matching placebo taken once daily

Sponsors & Collaborators

  • Biohaven Therapeutics Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-28
Primary Completion
2027-08-31
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT06976268 on ClinicalTrials.gov