Phase 23 Study of BHV-8000 Oral Treatment for Adults Ages 40 to 80 With Early Parkinsons Disease Double-Blind and Open-Label Treatment Phases

What this Trial Is About

Researchers are evaluating BHV-8000 as a potential treatment for adults diagnosed with early Parkinsons disease. This Phase 23 study aims to determine if BHV-8000 is effective, safe, and tolerable for this population. The trial includes a 48-week double-blind treatment phase followed by a 48-week open-label phase to further assess the drugs effects. During the double-blind phase, participants are randomly assigned to receive either BHV-8000 at two different oral doses 10 mg or 20 mg or a matching placebo. After completing this phase, all participants enter the open-label phase where they receive BHV-8000. The study uses a quadruple masking design to keep participants, investigators, and study staff unaware of treatment assignments during the blinded phase. Participants will be involved in regular assessments over a total of 96 weeks. Researchers will monitor changes in Parkinsons disease symptoms using tools like the Movement Disorder Society-Unified Parkinsons Disease Rating Scale MDS-UPDRS and DaT-SPECT scans. Safety will be closely tracked by recording adverse events and laboratory test results. The primary outcome is the time to first worsening event on the MDS-UPDRS Part II during the first 48 weeks.

A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease