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, BHV-8000, 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. 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 85 Years.
- Where is this trial located?
- This trial is recruiting at 15 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2/Phase 3 trial is estimated to last approximately 2 years and 2 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.