A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
Biohaven Therapeutics Ltd.
Summary
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Description
This study has two parts, Part A and Part B. Part A is randomized 1:1:1 25 mg of BHV-7000, 50 mg of BHV-7000 or matching placebo. Part B is randomized 1:1 75mg BHV-7000 or matching placebo. Part B will start after Part A.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 tol…
Interventions
- DrugBHV-7000
BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily
- DrugBHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
- DrugPlacebo
Matching placebo taken once daily
- DrugBHV-7000
BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
- DrugPlacebo
Matching placebo taken once daily
Locations (124)
- Barrow Neurological InstitutePhoenix, Arizona
- Center for NeurosciencesTucson, Arizona
- Clinical Trials, Inc.Little Rock, Arkansas
- WRNRogers, Arkansas
- University of California San DiegoLa Jolla, California
- University of California, Los AngelesLos Angeles, California