A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Launched by BIOHAVEN THERAPEUTICS LTD. · Nov 10, 2023
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called BHV-7000 for adults with refractory focal onset epilepsy, which means their seizures continue despite trying at least two different anti-seizure medications. The goal of the study is to see if BHV-7000 can help reduce seizure occurrences and improve the quality of life for people dealing with this challenging condition.
To participate, individuals must be between 18 and 75 years old and have been diagnosed with focal onset epilepsy for at least a year. They should also have been taking multiple epilepsy medications without achieving the desired control of their seizures. Participants will keep detailed records of their seizures throughout the study and may receive the new treatment alongside their current medications. This trial is actively recruiting, so if you or someone you know fits the criteria and is interested, it could be an opportunity to contribute to important research while exploring a potential new treatment option.
Gender
ALL
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 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
About Biohaven Therapeutics Ltd.
Biohaven Therapeutics Ltd. is a biopharmaceutical company focused on developing innovative treatments for neurological and psychiatric disorders. With a commitment to addressing unmet medical needs, Biohaven leverages cutting-edge science and advanced drug development methodologies to create transformative therapies. The company's pipeline includes novel compounds aimed at improving the lives of patients suffering from conditions such as migraine, depression, and neurodegenerative diseases. Through rigorous clinical trials and a dedication to research excellence, Biohaven strives to deliver impactful solutions that enhance patient care and drive advancements in the field of medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Philadelphia, Pennsylvania, United States
Los Angeles, California, United States
Saint Louis, Missouri, United States
Cincinnati, Ohio, United States
Salt Lake City, Utah, United States
Miami, Florida, United States
Nashville, Tennessee, United States
Phoenix, Arizona, United States
Philadelphia, Pennsylvania, United States
Stony Brook, New York, United States
Buenos Aires, , Argentina
Charlottesville, Virginia, United States
Houston, Texas, United States
Rennes, , France
Augusta, Georgia, United States
Little Rock, Arkansas, United States
Amherst, New York, United States
Praha, , Czechia
Maribor, , Slovenia
Tucson, Arizona, United States
Port Charlotte, Florida, United States
Gdansk, Pomorskie, Poland
Lexington, Kentucky, United States
Orlando, Florida, United States
Jacksonville, Florida, United States
Honolulu, Hawaii, United States
San Antonio, Texas, United States
Boise, Idaho, United States
Bradenton, Florida, United States
Edegem, Antwerpen, Belgium
Gent, Oost Vlaanderen, Belgium
Yvoir, Namur, Belgium
New York, New York, United States
Bruxelles, Brussels, Belgium
Zagreb, Grad Zagreb, Croatia
Warszawa, Mazowieckie, Poland
Woodmere, New York, United States
San Antonio, Texas, United States
Palo Alto, California, United States
Canton, Ohio, United States
Dijon, , France
St. Pölten, , Austria
Wien, , Austria
Dallas, Texas, United States
Cape Town, Western Cape, South Africa
Zürich, , Switzerland
świdnik, Lubelskie, Poland
Tampa, Florida, United States
Nancy, Meurthe Et Moselle, France
Miami, Florida, United States
Debrecen, , Hungary
Heeze, Noord Brabant, Netherlands
Ames, Iowa, United States
Anderlecht, Brussels, Belgium
Rijeka, , Croatia
Lublin, Lubelskie, Poland
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Kraków, , Poland
Zagreb, Grad Zagreb, Croatia
Winston Salem, North Carolina, United States
Elgin, Illinois, United States
Brno, Jihomoravský Kraj, Czechia
Warszawa, Mazowieckie, Poland
Rogers, Arkansas, United States
La Jolla, California, United States
Pasadena, California, United States
Boca Raton, Florida, United States
Weston, Florida, United States
Bethesda, Maryland, United States
Silver Spring, Maryland, United States
Rochester Hills, Michigan, United States
Hackensack, New Jersey, United States
Livingston, New Jersey, United States
New York, New York, United States
Charlotte, North Carolina, United States
Cypress, Texas, United States
Brno, , Czechia
Córdoba, , Argentina
Mooresville, North Carolina, United States
Aurora, Colorado, United States
Hawthorne, New York, United States
Burlington, Vermont, United States
Winter Park, Florida, United States
Roseville, Minnesota, United States
Columbus, Ohio, United States
Richmond, Virginia, United States
Budapest, , Hungary
Poznań, Wielkopolskie, Poland
Roanoke, Virginia, United States
Fort Worth, Texas, United States
Linz, Oberösterreich, Austria
Salzburg, , Austria
Zürich, Zürich (De), Switzerland
New Haven, Connecticut, United States
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Praha, Praha, Hlavní Mesto, Czechia
Wrocław, Dolnoslaskie, Poland
Nowa Sól, Lubuskie, Poland
łódź, Lódzkie, Poland
Warszawa, Mazowieckie, Poland
Gdańsk, , Poland
Heemstede, Noord Holland, Netherlands
Zwolle, Overijssel, Netherlands
Strasbourg, Bas Rhin, France
Dijon, Côte D'or, France
Toulouse, Haute Garonne, France
Montpellier, Hérault, France
Tours, Indre Et Loire, France
Lille Cedex, Nord, France
Lyon, Rhône, France
Pécs, Baranya, Hungary
Debrecen, Hajdú Bihar, Hungary
Budapest, , Hungary
Temuco, Araucanía, Chile
Balvanera, Ciudad Autónoma De Buenosaires, Argentina
Buenos Aires, Ciudad Autónoma De Buenosaires, Argentina
Buenos Aires, Ciudad Autónoma De Buenosaires, Argentina
San Miguel De Tucumán, Tucumán, Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Córdoba, , Argentina
Santiago, Región Metropolitanadesantiago, Chile
Santiago, Región Metropolitanadesantiago, Chile
Santiago, Región Metropolitanadesantiago, Chile
Viña Del Mar, Valparaíso, Chile
Katowice, , Poland
Kraków, , Poland
Cape Town, Western Cape, South Africa
Temuco, , Chile
Santiago, , Chile
Balvanera, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
San Miguel De Tucumán, , Argentina
Linz, , Austria
Santiago, , Chile
Santiago, , Chile
Viña Del Mar, , Chile
Montpellier, , France
Lyon, , France
łódź, , Poland
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported