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
Plain-Language Summary
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.