Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
NCT ID: NCT06309966
Last Updated: 2025-12-23
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2/PHASE3
390 participants
INTERVENTIONAL
2024-05-13
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BHV-7000 50 mg
BHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
BHV-7000 75 mg
BHV-7000
BHV-7000 75 mg. Participants will take blinded investigational product (IP) once daily
Placebo
Placebo
Matching placebo taken once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
BHV-7000
BHV-7000 75 mg. Participants will take blinded investigational product (IP) once daily
Placebo
Matching placebo taken once daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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 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
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Biohaven Therapeutics Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Accel Research
Birmingham, Alabama, United States
Onyx Clinical Trials
Peoria, Arizona, United States
Xenoscience, Inc.
Phoenix, Arizona, United States
University of Arizona / Banner University Medical Center Phoenix
Phoenix, Arizona, United States
ARENSIA Exploratory Medicine
Phoenix, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
Amicis Research Center
Lancaster, California, United States
Memorialcare Miller Children's & Women's Hospital Long Beach
Long Beach, California, United States
Tri Valley Neurology Medical Associates, Inc.
Mission Hills, California, United States
Stanford University
Palo Alto, California, United States
Profound Research LLC
Poway, California, United States
Kaiser Permanente
Aurora, Colorado, United States
UConn Health
Farmington, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
EZR Research, LLC
Boca Raton, Florida, United States
Nova Clinical Research, LLC
Bradenton, Florida, United States
Las Mercedes Medical Research
Hialeah, Florida, United States
Coral Clinic Research
Homestead, Florida, United States
Dm Healthworks
Kissimmee, Florida, United States
Y&L Advance Health Care, Inc d/b/a Elite Clinical Research
Miami, Florida, United States
Serenity Research Center
Miami, Florida, United States
Research Institute of Orlando
Orlando, Florida, United States
Comprehensive Neurology Clinic
Orlando, Florida, United States
Panhandle Research & Medical Clinic
Pensacola, Florida, United States
Knight Neurology
Rockledge, Florida, United States
PENS
Tampa, Florida, United States
Encore Medical Research of Weston LLC.
Weston, Florida, United States
Accelerated Clinical Trials, LLC
Peachtree Corners, Georgia, United States
Bluegrass Epilepsy Research
Lexington, Kentucky, United States
OLORMC
Baton Rouge, Louisiana, United States
DelRicht Research
Baton Rouge, Louisiana, United States
Neurocare Of Louisiana
Covington, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
LSU Health Shreveport
Shreveport, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Boston Neuro Research
South Dartmouth, Massachusetts, United States
SRI International
Plymouth, Michigan, United States
University of Missouri Health Care
Columbia, Missouri, United States
Somnos Clinical Research
Lincoln, Nebraska, United States
NEREG
Hackensack, New Jersey, United States
Jersey Shore Medical Center
Neptune City, New Jersey, United States
Dent Neurosciences Research Center
Amherst, New York, United States
Northwell Health
Great Neck, New York, United States
Northwell Health Ped. Neurology
New Hyde Park, New York, United States
NYU Langone Health
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
UNC-Chapel Hill
Chapel Hill, North Carolina, United States
Cincinatti Children's Hospital
Cincinnati, Ohio, United States
Wright State University
Dayton, Ohio, United States
Oregon Neurology Associates
Springfield, Oregon, United States
AHN
Pittsburgh, Pennsylvania, United States
MUSC
Charleston, South Carolina, United States
WR-ClinSearch
Chattanooga, Tennessee, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Horizon Clinical Research Group
Cypress, Texas, United States
M3 Wake Research-Dallas
Dallas, Texas, United States
ANESC Research
El Paso, Texas, United States
Tarrant Neurology Associates
Fort Worth, Texas, United States
UTHealth Houston
Houston, Texas, United States
UTHSC
Houston, Texas, United States
Stryde Research
Plano, Texas, United States
Intermountain Health
Murray, Utah, United States
Medstar Health Research Institute
McLean, Virginia, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia
St Vincents Hospital Melbourne - PPDS
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Flinders Medical Centre
Bedford Park, , Australia
Odense Universitetshospital
Odense, Fyn, Denmark
Kuopion yliopistollinen sairaala
Kuopio, Northern Savonia, Finland
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, Finland
Helsinki University Hospital
Helsinki, Uusimaa, Finland
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Epilepsiezentrum Kork
Kehl, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
LMU Klinikum der Universität München - Campus Großhadern
München, Bavaria, Germany
Epilepsieklinik Tabor
Bernau bei Berlin, Brandenburg, Germany
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
Marburg, Hesse, Germany
Klinikum Osnabrück GmbH
Osnabrück, Lower Saxony, Germany
Krankenhaus Mara gGmbH
Bielefeld, North Rhine-Westphalia, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
Radeberg, Saxony, Germany
Vivantes - Humboldt Klinikum
Berlin, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
Epilepsie-Zentrum Bodensee
Ravensburg, , Germany
University General Hospital of Alexandroupolis
Alexandroupoli, , Greece
University General Hospital ''ATTIKON''
Chaïdári, , Greece
University General Hospital of Ioannina
Ioannina, , Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, , Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, , Greece
Nizam's Insti. of Medical Sciences
Hyderabad, , India
Mallikatta Neuro Centre
Mangalore, , India
Jaslok Hospital and Research
Mumbai, , India
Dr G M Taori Memorial CIIMS
Nagpur, , India
All India Institute of Medical Sciences (AIIMS)
New Delhi, , India
Università degli Studi G. D'Annunzio Chieti-Pescara
Chieti, Abruzzo, Italy
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
Catanzaro, Calabria, Italy
AORN Antonio Cardarelli
Napoli, Campania, Italy
AUSL di Bologna - Ospedale Bellaria
Bologna, Emilia-Romagna, Italy
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, Italy
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genoa, Liguria, Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardy, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
Milan, Lombardy, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Lombardy, Italy
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Baggiovara, Modena, Italy
IRCCS Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Molise, Italy
Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, The Marches, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Calambrone, Tuscany, Italy
Fondazione Policlinico Universitario A Gemelli-Rome
Roma, , Italy
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Rome, , Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, , Italy
Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
Mexico City, , Mexico
Clinstile, S.A. de C.V.
Mexico City, , Mexico
Accelerium, S. de R.L. de C.V. - PPDS
Monterrey, , Mexico
Axis Heilsa S. de R.L. de C.V.
Obispado, , Mexico
Neurociencias Estudios Clinicos S.C.
Sinaloa, , Mexico
Clinical Research Institute SC-Mexico
Tlalnepantla, , Mexico
FAICIC S De RL De CV
Veracruz, , Mexico
MTZ Clinical Research
Krakow, , Poland
Pratia MCM Krakow
Krakow, , Poland
LANDA Specjalistyczne
Krakow, , Poland
Neurosphera SP. Z O.O
Warsaw, , Poland
Premium Clinic Wrocław
Wroclaw, , Poland
ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
Santa Maria da Feira, Aveiro District, Portugal
ULS de Matosinhos, EPE - Hospital Pedro Hispano
Senhora da Hora, Porto District, Portugal
Centro Clínico Académico, Braga - Hospital de Braga
Braga, , Portugal
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, , Portugal
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, , Portugal
Hospital da Luz Torres de Lisboa
Lisbon, , Portugal
Targu-Mures Emergency Clinical County Hospital - Str. Gh. Marinescu nr.50
Târgu Mureş, Mureș County, Romania
Emergency University Hospital
Bucharest, , Romania
IN MEDIC, s.r.o.
Bardejov, , Slovakia
Kraskova 2636, Neurologické oddelenie
Rimavská Sobota, , Slovakia
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Fundacio Assistencial Mutua de Terrassa
Barcelona, , Spain
Hospital Universitario Clínico San Cecilio
Granada, , Spain
Hospital Vithas Granada
Granada, , Spain
Hospital Universitario Virgen de Las Nieves
Granada, , Spain
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Blua Sanitas Valdebebas Hospital
Madrid, , Spain
Hospital blua sanitas valdebebas
Madrid, , Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga, , Spain
Centro de Neurologia Avanzada
Seville, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Morriston Hospital
Swansea, Glamorgan, United Kingdom
Queen Elizabeth University Hospital-PPDS
Glasgow, Glasgow City, United Kingdom
Salford Royal Hospital - PPDS
Salford, Manchester, United Kingdom
The Walton Centre - PPDS
Liverpool, Merseyside, United Kingdom
University College London Hospitals (UCLH)
London, Middlesex, United Kingdom
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom
University Hospital of Wales
Cardiff, South Glamorgan, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Derek Soto
Role: primary
Corina Lugo
Role: primary
Francine Metcalf-Nodwell
Role: primary
April Tenorio
Role: primary
Ellen Ciesielski
Role: primary
Yalexis Lorenzo
Role: primary
Fernando Roa
Role: primary
Michelle Clevenger
Role: primary
Elliuz Leal
Role: primary
Joseph Hilde
Role: primary
Susan Ngo
Role: primary
Danielle Bryant
Role: primary
Heather Scuderi
Role: primary
Reggie Mister
Role: primary
Erin Yates
Role: primary
Pamela Coe
Role: primary
Joanne Monaghan
Role: primary
Wendy Bradford
Role: primary
Ayesha Rehman
Role: primary
Mariana Figuera Losada
Role: primary
Monica Coudurier
Role: primary
Megan Hendricks
Role: primary
Robin Bulgarino
Role: primary
Jessica Benvenuto
Role: primary
Kerry Moore
Role: primary
Shruti Konda
Role: primary
Maria Poblete
Role: primary
Lindsay Bosh
Role: primary
Emma Merrill
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-508811-21
Identifier Type: REGISTRY
Identifier Source: secondary_id
BHV7000-303
Identifier Type: -
Identifier Source: org_study_id