Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06976268 | A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease | PHASE2 | RECRUITING | 550 | — | — | May 28, 2025 | Sep 1, 2027 | Jan 14, 2026 | 15 | United States |
To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the time to prespecified worsening on MDS-UPDRS Part II (motor experiences of daily living per self-administered questionnaire). MDS-UPDRS Part II is a 52-point scale with a higher total score representing more severe disability.
| Arm | Type | Description |
|---|---|---|
| BHV-8000 10 mg | EXPERIMENTAL | - |
| BHV-8000 20 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BHV-8000 | DRUG | BHV-8000 10 mg. Participants will take blinded investigational product (IP) once daily |
| Placebo | DRUG | Matching placebo taken once daily |
Key Inclusion Criteria: * Male or female participants 40 to 85 years of age, inclusive, at the time of informed consent. * Meet the diagnostic criteria for "Probable PD" as assessed on the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD as assessed by the Investigator. * Have a ...