Recruiting
Phase 2
Phase 3

BHV-8000

Sponsor:

Biohaven Therapeutics Ltd.

Code:

NCT06976268

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

BHV-8000 10mg

BHV-8000 20 mg

Placebo

Study Details

Brief summary:

A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease. The study will consist of a 48-week double-blind treatment phase followed by a 48-week open-label phase.

Conditions

Parkinson Disease

Study ID

NCT06976268

Start date

May 28, 2025

Status verified date

Sep, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Male or female participants 40 to 80 years of age, inclusive, at the time of informed consent.
  • Meet the diagnostic criteria for "Probable PD" as assessed on the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD as assessed by the Investigator.
  • Have a clinician-documented diagnosis of idiopathic PD with an onset within 2 years of the Screening Visit

Key Exclusion Criteria:

  • Medical history indicating a Parkinsonian syndrome other than idiopathic PD, including, but not limited to, progressive supranuclear gaze palsy, multiple system atrophy, drug-induced Parkinsonism, essential tremor, or primary dystonia.
  • Diagnosis of clinically significant central nervous system (CNS) disease other than PD.
  • Participants who are current smokers (defined as smoking \[in any form, e.g., tobacco smoke, electronic cigarettes, etc.\] )
  • Treatment with PD medication(s)
  • Any other condition(s) that may compromise participant safety, interfere with study conduct, or jeopardize the potential proper interpretation of study results, in the opinion of the investigator.

Study Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BHV-8000 10 mg

Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP.

Open-label Phase: Participants will receive BHV-8000.

experimental: BHV-8000 20 mg

Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP.

Open-label Phase: Participants will receive BHV-8000.

placebo comparator: Placebo

Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP (matching placebo).

Open-label Phase: Participants will receive BHV-8000.

Interventions

BHV-8000 10mg

taken orally

BHV-8000 20 mg

taken orally

Placebo

taken orally

Primary outcome measure

  • Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II [ Time Frame: Up to 48 Weeks ]

Central Contacts and Locations

Central contacts

Chief Medical Officer

203-404-0410clinicaltrials@biohavenpharma.com

Locations

Site-049

Recruiting

Birmingham, Alabama, United States, 35294

Site-041

Recruiting

Los Angeles, California, United States, 90033

Site-025

Recruiting

Aurora, Colorado, United States, 80045

Site-031

Recruiting

Farmington, Connecticut, United States, 06030

Site-028

Recruiting

New Haven, Connecticut, United States, 06510

Site-038

Recruiting

Atlantis, Florida, United States, 33462

Site-017

Recruiting

Boca Raton, Florida, United States, 33486

Site-051

Recruiting

Maitland, Florida, United States, 32751

Site-027

Recruiting

Chicago, Illinois, United States, 60611

Site-071

Recruiting

Boston, Massachusetts, United States, 02114

Site-004

Recruiting

Foxborough, Massachusetts, United States, 02035

Site-015

Recruiting

Farmington Hills, Michigan, United States, 48334

Site-044

Recruiting

Chesterfield, Missouri, United States, 63005

Site-006

Recruiting

Albany, New York, United States, 12208

Site-005

Recruiting

New York, New York, United States, 10021

Site-091

Recruiting

Portland, Oregon, United States, 97210

Site-043

Recruiting

Round Rock, Texas, United States, 78681

Site-074

Recruiting

Newport News, Virginia, United States, 23601

Site-007

Recruiting

Bellevue, Washington, United States, 98007

More Information

Sponsor

Biohaven Therapeutics Ltd.

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Early Parkinson's Disease
  • Parkinson's Disease
  • Early stage Parkinson's Disease
  • treatment naiive early Parkinson's Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Biohaven Therapeutics Ltd. on 2026-09-03.