BHV-8000 for Parkinson's Disease

Recruiting at 1 trial location

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Biohaven Therapeutics Ltd.

Must not be taking: PD medications

Disqualifiers: Other Parkinsonian syndromes, CNS disease, smokers, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

550 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

Adults aged 40 to 85 with a recent diagnosis of idiopathic Parkinson's Disease (PD), confirmed by the Movement Disorder Society criteria. Participants must have been diagnosed within the last two years and be able to give informed consent.

Inclusion Criteria

I am between 40 and 85 years old.

I have been diagnosed with Parkinson's disease by a specialist.

I was diagnosed with Parkinson's disease within the last 2 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BHV-8000 or placebo for up to 48 weeks to evaluate efficacy, safety, and tolerability

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BHV-8000

Trial Overview The trial is testing BHV-8000 for effectiveness, safety, and tolerability in treating early-stage Parkinson's Disease. It compares BHV-8000 against a placebo to see if it can improve PD symptoms.

Participant Groups

Group I: BHV-8000 10 mg Experimental Treatment 1 Intervention

Group II: BHV-7000 20 mg Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Biohaven Therapeutics Ltd.

Lead Sponsor

Trials

13

Recruited

4,800+