BHV-8000 10mg for Parkinson's (NCT06976268)
New medication slows Parkinson progression
- Trial ID
- NCT06976268
- Official Title
- A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease
- Goal
- New medication slows Parkinson progression
- Phase
- PHASE2, PHASE3
- Status
- RECRUITING
- Sponsor
- Biohaven Therapeutics Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 550 participants
- Conditions
- Parkinson Disease
- Interventions
- BHV-8000 10mg, BHV-8000 20 mg, Placebo
Summary For Families
The goal is to see whether BHV-8000 can slow or alter disease progression in people with very early Parkinson's, aiming to reduce the underlying brain changes that lead to worsening motor symptoms before standard Parkinson's drugs are started. BHV-8000 is an experimental oral medication thought to act on biological pathways tied to neuron dysfunction and loss; participants are randomly given BHV-8000 or placebo so researchers can measure its effects without the influence of levodopa or other PD treatments. The trial is looking for people aged 40 to 85 with a clinician-confirmed probable idiopathic Parkinson's diagnosis within the last two years, who are not current smokers and are not taking Parkinson's medications, with other significant CNS conditions excluded.
Locations
- Site-049, Birmingham, Alabama, United States
- Site-041, Los Angeles, California, United States
- Site-031, Farmington, Connecticut, United States
- Site-028, New Haven, Connecticut, United States
- Site-038, Atlantis, Florida, United States
- Site-017, Boca Raton, Florida, United States
- Site-051, Maitland, Florida, United States
- Site-027, Chicago, Illinois, United States
- Site-071, Boston, Massachusetts, United States
- Site-015, Farmington Hills, Michigan, United States
- Site-044, Chesterfield, Missouri, United States
- Site-005, New York, New York, United States
- Site-091, Portland, Oregon, United States
- Site-043, Round Rock, Texas, United States
- Site-007, Bellevue, Washington, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying BHV-8000 10mg. The goal is to see whether BHV-8000 can slow or alter disease progression in people with very early Parkinson's, aiming to reduce the underlying brain changes that lead to worsening motor symptoms before standard Parkinson's drugs are started. BHV-8000 is an experimental oral medication thought to act on biological pathways tied to neuron dysfunction and loss; participants are randomly given BHV-8000 or placebo so researchers can measure its effects without the influence of levodopa or other PD treatments. The trial is looking for people aged 40 to 85 with a clinician-confirmed probable idiopathic Parkinson's diagnosis within the last two years, who are not current smokers and are not taking Parkinson's medications, with other significant CNS conditions excluded.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 15 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2/Phase 3 trial is estimated to last approximately 2 years and 2 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 3 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 3 chance (roughly 33%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.