A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
NCT ID: NCT06132893
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
390 participants
INTERVENTIONAL
2024-03-14
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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BHV-7000 25 mg Part A
BHV-7000
BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily
BHV-7000 50 mg Part A
BHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
Placebo Part A
Placebo
Matching placebo taken once daily
BHV-7000 75 mg Part B
BHV-7000
BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
Placebo Part B
Placebo
Matching placebo taken once daily
Interventions
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BHV-7000
BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily
BHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
Placebo
Matching placebo taken once daily
BHV-7000
BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
Placebo
Matching placebo taken once daily
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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Biohaven Therapeutics Ltd.
INDUSTRY
Responsible Party
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Locations
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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
University of Florida (Jacksonville)
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Floridian Research Institute
Miami, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Medsol Clinical Research Center
Port Charlotte, Florida, United States
Santos Research Center
Tampa, Florida, United States
Encore Medical Research of Weston LLC.
Weston, Florida, United States
Pediatrix Medical Group of Florida
Winter Park, Florida, United States
Augusta University
Augusta, Georgia, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Revive Research Institute, Inc.
Elgin, Illinois, United States
Accellacare
Ames, Iowa, United States
Bluegrass Epilepsy Research
Lexington, Kentucky, United States
MAESC
Bethesda, Maryland, United States
Javara
Silver Spring, Maryland, United States
Revive Research Institute, Inc.
Rochester Hills, Michigan, United States
Minnesota Epilepsy Group, P.A.
Roseville, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
NEREG
Hackensack, New Jersey, United States
Inst of Neurology
Livingston, New Jersey, United States
Dent Neurosciences Research Center
Amherst, New York, United States
BCHP
Hawthorne, New York, United States
Northwell Health
New York, New York, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
Stony Brook Medicine
Stony Brook, New York, United States
Five Towns Neuroscience Research
Woodmere, New York, United States
OnSite Clinical Solutions
Charlotte, North Carolina, United States
Accellacare
Mooresville, North Carolina, United States
Wake Forest Baptist
Winston-Salem, North Carolina, United States
NeuroScience Research Center
Canton, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
OSU
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
UPMC
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Clinical Research Solutions LLC
Cypress, Texas, United States
Neurology Consultants of Dallas, PA
Dallas, Texas, United States
Tarrant Neurology Consultants
Fort Worth, Texas, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, United States
UT Health San Antonio
San Antonio, Texas, United States
Road Runner Research, Ltd
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
UVM MC
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Henrico Doctors Neurology Associates, LLC
Richmond, Virginia, United States
Carilion Clinic
Roanoke, Virginia, United States
STAT Research S.A.
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital General de Agudos Dr. José María Ramos Mejia
Balvanera, Ciudad Autónoma de BuenosAires, Argentina
Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Hospital Británico de Buenos Aires
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Investigaciones Sanatorio Del Sur
San Miguel de Tucumán, Tucumán Province, Argentina
Sanatorio de la Trinidad - Mitre
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
Buenos Aires, , Argentina
Instituto Privado Kremer
Córdoba, , Argentina
Conci Carpinella - Santa Rosa N° 748
Córdoba, , Argentina
Kepler Universitätsklinikum Linz - Med Campus III
Linz, Upper Austria, Austria
Christian Doppler-Klinik - Universitätsklinikum der PMU
Salzburg, , Austria
Universitätsklinikum St. Pölten
Sankt Pölten, , Austria
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, , Austria
UZ Antwerpen
Edegem, Antwerpen, Belgium
Hôpital Erasme
Anderlecht, Brussels Capital, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
CHU UCL Namur - Site Godinne
Yvoir, Namur, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
Centro de especialidades médicas Vanguardia
Temuco, Región de la Araucanía, Chile
Instituto Neurologico Thalamus
Viña del Mar, Región de Valparaíso, Chile
Hospital Padre Hurtado
Santiago, Región-MetropolitanadeSantiago, Chile
BIOCINETIC Ltda
Santiago, Región-MetropolitanadeSantiago, Chile
Centro de Investigacion Clinica UC
Santiago, Región-MetropolitanadeSantiago, Chile
Clinical Hospital Sveti duh
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29
Zagreb, City of Zagreb, Croatia
Clinical Hospital Center Rijeka - PPDS
Rijeka, , Croatia
Fakultni nemocnice v Motole
Prague, Praha, Hlavní Mesto, Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, South Moravian, Czechia
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, Bas-Rhin, France
CHU Dijon Bourgogne
Dijon, Côte-d'Or, France
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
Toulouse, Haute-Garonne, France
CHU de Montpellier- Hôpital Gui De Chauliac
Montpellier, Hérault, France
CHRU de Tours - Hôpital Bretonneau
Tours, Indre-et-Loire, France
CHRU Nancy
Nancy, Meurthe-et-Moselle, France
CHU de Lille - Hopital Claude Huriez
Lille, Nord, France
Hospices Civils de Lyon - 59 Bd Pinel
Lyon, Rhône, France
Hôpital Pontchaillou
Rennes, , France
Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
Pécs, Baranya, Hungary
Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus
Debrecen, Hajdú-Bihar, Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, , Hungary
SE INK Juhasz Pal Epilepszia Központ
Budapest, , Hungary
Kempenhaeghe - PPDS
Heeze, North Brabant, Netherlands
Stichting Epilepsie Instellingen Nederland - Heemstede
Heemstede, North Holland, Netherlands
Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20
Zwolle, Overijssel, Netherlands
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, Poland
Przychodnia VISTAMED
Wroclaw, Lower Silesian Voivodeship, Poland
Clinical Best Solutions - Lublin
Lublin, Lublin Voivodeship, Poland
NZOZ IGNIS dr med. Alicja Lobinska
Świdnik, Lublin Voivodeship, Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
Nowa Sól, Lubusz Voivodeship, Poland
Santa Familia PTG Lodz
Lodz, Lódzkie, Poland
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, Masovian Voivodeship, Poland
Neurosphera SP. Z O.O
Warsaw, Masovian Voivodeship, Poland
Instytut Psychiatrii i Neurologii
Warsaw, Masovian Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6
Gdansk, , Poland
Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44
Katowice, , Poland
Pratia MCM Kraków
Krakow, , Poland
LANDA Specjalistyczne Gabinety Lekarskie
Krakow, , Poland
University Clinical Centre Maribor
Maribor, , Slovenia
InnoMed Clinical Trial Centre
Cape Town, Western Cape, South Africa
Groote Schuur Hospital
Cape Town, Western Cape, South Africa
Klinik Lengg AG
Zurich, Zürich (de), Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-508539-30
Identifier Type: REGISTRY
Identifier Source: secondary_id
BHV7000-302
Identifier Type: -
Identifier Source: org_study_id
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