A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Ons
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
| Condition(s) | Focal Epilepsy |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| Summary | The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy. |
| Who can participate | Key Inclusion Criteria: 1. Male and Female participants 18 to 75 years of age at time of consent. 2. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria. a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures iii. Focal to bilateral tonic-clonic seizures 3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom. 4. Ability to keep accurate seizure diari |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Biohaven Therapeutics Ltd. |
| Locations | Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Rogers, Arkansas, United States; La Jolla, California, United States; Los Angeles, California, United States (+118 more sites) |
| Start date | 2024-03-14 |
| NCT ID | NCT06132893 |
| Official listing | https://clinicaltrials.gov/study/NCT06132893 |