BHV-8000 for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called BHV-8000, an experimental drug, to determine its effectiveness for individuals diagnosed with early Parkinson's disease. Researchers aim to assess the treatment's safety, tolerability, and efficacy. Participants will join one of three groups, receiving either BHV-8000 at varying doses or a placebo, which contains no active medicine. The trial seeks individuals who have had Parkinson's disease for less than two years and have not taken Parkinson's medication for more than 28 days. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop taking my current medications for the trial?
Yes, you will need to stop taking any Parkinson's disease medications to participate in this trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that BHV-8000 has promising safety results from earlier studies. In previous research with healthy adults, BHV-8000 was well-tolerated, causing no serious problems. No serious side effects were reported, and any side effects were generally mild. This is encouraging as BHV-8000 is now being tested for early Parkinson's disease. The treatment targets specific enzymes linked to brain inflammation, which is important for Parkinson's. Its current phase, which assesses both safety and effectiveness, suggests confidence in its safety for humans.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about BHV-8000 because it brings a fresh approach to treating Parkinson's disease. Unlike the standard treatments, which often focus on replenishing dopamine levels or managing symptoms through medications like Levodopa, BHV-8000 works on a potentially new mechanism that targets different pathways involved in the disease. This could mean fewer side effects and a more direct impact on disease progression. Additionally, the trial also includes BHV-7000 at a different dosage, which may offer further insights into optimizing treatment efficacy. These innovative approaches have the potential to significantly improve life quality for those living with Parkinson's.
What evidence suggests that this trial's treatments could be effective for Parkinson's disease?
Research has shown that BHV-8000 might help people with early Parkinson's disease. Studies have found that BHV-8000, which targets brain pathways related to inflammation, can improve movement in animals. For instance, animals given BHV-8000 moved 36.8% to 61.4% more. This trial will test BHV-8000 at different dosages to evaluate its effectiveness in improving movement in people with Parkinson's. Although more information is needed, these results offer promise for those seeking new treatment options.12367
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BHV-8000 or placebo for up to 48 weeks to evaluate efficacy, safety, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BHV-8000
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biohaven Therapeutics Ltd.
Lead Sponsor