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Taking peoplePhase 2/3

Testing BHV-8000 as a Treatment for Early Parkinson's Disease

Tests BHV-8000 against placebo in adults with early Parkinson's disease.

Plain-language title generated from the registry record
Registry title: A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease

Key facts

Where
Brno-Stred, Choceň, and Jihlava 1, CzechiaSee the 3 sites
Phase
Phase 2/3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40 to 80 with early Parkinson's disease to test BHV-8000 against a placebo.

Age
40 to 80 years, inclusive.
Sex
Men and women can join.
Disease stage
Probable Parkinson's disease by the MDS diagnostic criteria, with a doctor-documented diagnosis of idiopathic Parkinson's disease that began within 2 years of the Screening Visit.
Earlier treatment
People currently treated with Parkinson's disease medicines cannot join.

Main reasons for not taking part

  • A parkinsonian syndrome other than idiopathic Parkinson's disease, such as multiple system atrophy, drug-induced parkinsonism, essential tremor or primary dystonia
  • Another significant central nervous system disease besides Parkinson's disease
  • Current smokers, including electronic cigarettes
  • Treatment with Parkinson's disease medicines
  • Any other condition the investigator thinks may affect safety or the study results

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 80 years old?
  • Has a doctor told you that you have a different condition with similar signs, such as multiple system atrophy or progressive supranuclear palsy?
  • How long ago were you diagnosed with Parkinson's disease?
  • Which medicine do you take for Parkinson's disease now?

Source: NCT06976268, who can take part

Where in Czechia

  • Fakultni Nemocnice U Sv Anny V BrneBrno-Stred, CzechiaNot yet recruiting
  • NEUROHK s r oChoceň, CzechiaNot yet recruiting
  • Nemocnice Jihlava prispevkova organizaceJihlava 1, CzechiaNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Biohaven Therapeutics Ltd.
Trial code
NCT06976268EU 2025-521113-13-00
Record updated
22 October 2026
Original description
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.Read full original descriptionShow less

A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease

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.

Inclusion: 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.

Exclusion: Treatment with PD medication(s); 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; 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; Participants who are current smokers (defined as smoking [in any form, e.g., tobacco smoke, electronic cigarettes, etc.] ).

ClinicalTrials.gov NCT06976268 · EU CTIS 2025-521113-13-00