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RecruitingPhase 2/Phase 3

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

Biohaven Therapeutics Ltd. · NCT06976268

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
550
US sites recruiting
25
Study start
May 28, 2025
Record last updated
October 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: BHV-8000 10mg; BHV-8000 20 mg; Placebo

Conditions: Parkinson Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

Study contacts (from the official record)

  • Chief Medical Officer · 203-404-0410 · clinicaltrials@biohavenpharma.com
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A Study to Determine if BHV-8000 is Effective, Safe and Tolerable… (NCT06976268) | Bored Studies