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

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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 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

🚫 You may not be able to join if…

• 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.
• History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
• Resection neurosurgery for seizures <4 months prior to the screening visit.
• Radiosurgery performed <2 years prior to the screening visit.
• 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.
• 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

Where this trial is running

• Barrow Neurological Institute, Phoenix, Arizona, United States
• Center for Neurosciences, Tucson, Arizona, United States
• Clinical Trials, Inc., Little Rock, Arkansas, United States
• WRN, Rogers, Arkansas, United States
• University of California San Diego, La Jolla, California, United States
• University of California, Los Angeles, Los Angeles, California, United States
• Stanford Health Care, Palo Alto, California, United States
• Profound Research LLC, Pasadena, California, United States
• University of Colorado Anschultz Medical Campus, Aurora, Colorado, United States
• Yale School of Medicine - Yale-New Haven Hospital, New Haven, Connecticut, United States
• EZR Research LLC, Boca Raton, Florida, United States
• Nova Clinical Research, LLC, Bradenton, Florida, United States

+ 112 more sites.

Who to contact

Chief Medical Officer · 203-404-0410 · clinicaltrials@biohavenpharma.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06132893.