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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521113-13-00 | EU Trial (CTIS) Number |
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A study to determine if BHV-8000 is efficacious, safe and tolerable in adults diagnosed with early Parkinson's disease. The study will consist of a 48-week double-blind treatment phase followed by a 48-week open-label phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHV-8000 10 mg | Experimental | Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP. Open-label Phase: Participants will receive BHV-8000. |
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| BHV-8000 20 mg | Experimental | Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP. Open-label Phase: Participants will receive BHV-8000. |
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| Placebo | Placebo Comparator | Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP (matching placebo). Open-label Phase: Participants will receive BHV-8000. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BHV-8000 10mg | Drug | taken orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first qualifying worsening event on Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II | 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. | Up to 48 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III from Baseline to Week 48 of the DB Phase | To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the change in MDS-UPDRS Part III (motor examination conducted by rater). MDS-UPDRS Part III is a 132-point scale with a higher total score representing a greater degree of motor impairment. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Contact | 203-404-0410 | clinicaltrials@biohavenpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site-049 | Recruiting | Birmingham | Alabama | 35294 | United States | |
| Site-041 |
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| BHV-8000 20 mg |
| Drug |
taken orally |
|
| Placebo | Drug | taken orally |
|
| Baseline to Week 48 |
| Change in Clinical Global Impression of Severity (CGI-S) from Baseline to Week 48 of the DB Phase | To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the change in severity of a participant's illness as determined by the managing clinician. The CGI-S is a 7-point scale (1 - 7) with 7 representing the most extremely ill participants. | Baseline to Week 48 |
| Change in DaT-SPECT scan from Baseline to Week 48 of the DB Phase | To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by change in DaT-SPECT Striatal Binding Ratio (SBR) in the putamen (assessing the activity of the dopamine transporters). Reduced uptake of the radiotracer is indicative of a decreased number of dopamine-secreting cells and suggestive of disease progression. | Baseline to Week 48 |
| Change in Parkinson's Disease Composite Score - Function (PARCOMS-Function) from Baseline to Week 48 of the DB Phase | To compare the efficacy of BHV-8000 compared to placebo. This objective is measured by changes in the Parkinson's Disease Composite Score - Function (PARCOMS-Function) score. The PARCOMS-Function is a composite of select items taken from the MDS-UPDRS Part II and the PDQ-39© (assessing ability to complete daily activities). The PARCOMS-Function is a 100-point scale (0 - 100) with higher scores representing greater dysfunction. | Baseline to Week 48 |
| Number of Participants with Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs | To assess the safety and tolerability of BHV-8000. This objective will be measured by assessing the number of unique participants with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs | Up to 96 weeks |
| Number of participants with clinically significant laboratory abnormalities | To assess the safety and tolerability of BHV-8000. This objective will be measured by assessing the number of unique participants with treatment-emergent Grade 3 and 4 laboratory abnormalities | Up to 96 weeks |
| Recruiting |
| Los Angeles |
| California |
| 90033 |
| United States |
| Site-031 | Recruiting | Farmington | Connecticut | 06030 | United States |
| Site-028 | Recruiting | New Haven | Connecticut | 06510 | United States |
| Site-038 | Recruiting | Atlantis | Florida | 33462 | United States |
| Site-017 | Recruiting | Boca Raton | Florida | 33486 | United States |
| Site-051 | Recruiting | Maitland | Florida | 32751 | United States |
| Site-027 | Recruiting | Chicago | Illinois | 60611 | United States |
| Site-071 | Recruiting | Boston | Massachusetts | 02114 | United States |
| Site-015 | Recruiting | Farmington Hills | Michigan | 48334 | United States |
| Site-044 | Recruiting | Chesterfield | Missouri | 63005 | United States |
| Site-005 | Recruiting | New York | New York | 10021 | United States |
| Site-091 | Recruiting | Portland | Oregon | 97210 | United States |
| Site-043 | Recruiting | Round Rock | Texas | 78681 | United States |
| Site-007 | Recruiting | Bellevue | Washington | 98007 | United States |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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