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Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

NCT06309966

Active Not RecruitingPhase 2, Phase 3

Sponsor: Biohaven Therapeutics Ltd.

Conditions: Focal Epilepsy

Interventions: BHV-7000, BHV-7000, Placebo

Countries: United States, Australia, Denmark, Finland, Germany, Greece, Hungary, India

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 with clinically observable signs and/or symptoms 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 diaries
5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total

Key Exclusion Criteria:

1. History of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired consciousness for \> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.
2. History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
3. Resection neurosurgery for seizures \<4 months prior to the screening visit.
4. Radiosurgery performed \<2 years prior to the screening visit.
5. Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms.
6. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator

Locations (150)

Peoria, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Mission Hills, California, United States
Poway, California, United States
Farmington, Connecticut, United States
Bradenton, Florida, United States
Hialeah, Florida, United States
Homestead, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Rockledge, Florida, United States
Weston, Florida, United States
Peachtree Corners, Georgia, United States
Lexington, Kentucky, United States
Baton Rouge, Louisiana, United States
Covington, Louisiana, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
South Dartmouth, Massachusetts, United States
Plymouth, Michigan, United States
Columbia, Missouri, United States
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