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

Biohaven

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: Placebo; Drug: BHV-8000

Study type: Interventional

Funder types: Industry

Identifiers

NCT06976268

2025-521113-13-00 (EU Trial (CTIS) Number)

BHV8000-301

Details and patient eligibility

About

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

Enrollment: 550 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female participants 40 to 85 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.] within 6 months prior to the Baseline Visit).
• Treatment with PD medication(s) for a total of more than 28 days or treatment with any PD medication within 90 days of the Baseline Visit.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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550 participants in 3 patient groups, including a placebo group

BHV-8000 10 mg

Experimental group

Treatment:

Drug: BHV-8000

Drug: BHV-8000

BHV-7000 20 mg

Experimental group

Treatment:

Drug: BHV-8000

Drug: BHV-8000

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo