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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age40-85
SponsorBiohaven Therapeutics Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • BHV-8000
  • BHV-8000
  • Placebo

Treatment groups

550 Participants
are divided into 3 treatment groups

Sponsors and collaborators