A Phase 2/3 Multicenter, Randomization, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
A Phase 2/3 Multicenter, Randomization, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Key Inclusion Criteria:
Male and Female participants 18 to 75 years of age at time of consent.
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 with clinically observable signs and/or symptoms iii. Focal to bilateral tonic-clonic seizures
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.
Ability to keep accurate seizure diaries
Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total
Key Exclusion Criteria:
Phoenix, Arizona 85006, United States
Milan, Lombardy 20142, Italy
Baggiovara, Modena 41126, Italy
Santa Maria da Feira, Aveiro District 4520-211, Portugal