New pill aims to tame seizures in Drug-Resistant epilepsy

NCT ID NCT06309966

Disease control Sponsor: Biohaven Therapeutics Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 14, 2026 · Updated 5 times

Summary

This study tests whether a daily pill called BHV-7000 can reduce seizures in adults with refractory focal epilepsy—a type of epilepsy that doesn't respond well to current medications. About 390 participants will receive either a low dose, a higher dose, or a placebo for 8 weeks. The main goal is to see if the drug lowers monthly seizure counts compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: BHV-7000 (a daily pill)
What this could lead to: If it works, this could offer a new daily treatment option for people with hard-to-control focal epilepsy, potentially reducing seizure frequency.
What could go wrong: This is an early-to-mid-stage trial with only 390 participants. It may not show enough benefit over placebo, and side effects could limit its use. Results may not apply to all epilepsy types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 390 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Drug Resistant Epilepsy epilepsy focal epilepsy visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Focal epilepsy

Contacts and locations

Locations

AHEPA University General Hospital of Thessaloniki

Thessaloniki, 546 36, Greece
AHN

Pittsburgh, Pennsylvania, 15212, United States
ANESC Research

El Paso, Texas, 79912, United States
AORN Antonio Cardarelli

Naples, Campania, 80131, Italy
ARENSIA Exploratory Medicine

Phoenix, Arizona, 85015, United States
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo

Milan, Lombardy, 20142, Italy
AUSL di Bologna - Ospedale Bellaria

Bologna, Emilia-Romagna, 40123, Italy
Aarhus University Hospital

Aarhus, 8200, Denmark
Accelerated Clinical Trials, LLC

Peachtree Corners, Georgia, 30071, United States
Accelerium, S. de R.L. de C.V. - PPDS

Monterrey, 64000, Mexico
All India Institute of Medical Sciences (AIIMS)

New Delhi, 110029, India
Austin Health

Heidelberg, Victoria, 3084, Australia
Axis Heilsa S. de R.L. de C.V.

Obispado, 64060, Mexico
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini

Catanzaro, Calabria, 88100, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

Calambrone, Tuscany, 56018, Italy
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara

Baggiovara, Modena, 41126, Italy
Bluegrass Epilepsy Research

Lexington, Kentucky, 40504, United States
Boston Clinical Trials

Boston, Massachusetts, 02131, United States
Boston Neuro Research

South Dartmouth, Massachusetts, 02747, United States
CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain
Centro Clínico Académico, Braga - Hospital de Braga

Braga, 4710-243, Portugal
Centro de Neurologia Avanzada

Seville, 41013, Spain
Clinical Research Institute SC-Mexico

Tlalnepantla, 54055, Mexico
Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States
Clinstile, S.A. de C.V.

Mexico City, 06700, Mexico
Comprehensive Neurology Clinic

Orlando, Florida, 32825, United States
Coral Clinic Research

Homestead, Florida, 33032, United States
DelRicht Research

Baton Rouge, Louisiana, 70810, United States
DelRicht Research

New Orleans, Louisiana, 70119, United States
Dent Neurosciences Research Center

Amherst, New York, 14226, United States
Dr G M Taori Memorial CIIMS

Nagpur, 440010, India
Emergency University Hospital

Bucharest, 11635, Romania
Encore Medical Research of Weston LLC.

Weston, Florida, 33331, United States
Epilepsie-Zentrum Bodensee

Ravensburg, 88214, Germany
Epilepsieklinik Tabor

Bernau bei Berlin, Brandenburg, 16321, Germany
Epilepsiezentrum Kork

Kehl, Baden-Wurttemberg, 77694, Germany
Epilepsihospitalet Filadelfia

Dianalund, 4293, Denmark
FAICIC S De RL De CV

Veracruz, 91900, Mexico
Flinders Medical Centre

Bedford Park, 5042, Australia
Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, 20133, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Lombardy, 27100, Italy
Fondazione PTV Policlinico Tor Vergata

Rome, Lazio, 00133, Italy
Fondazione Policlinico Universitario A Gemelli-Rome

Roma, 00168, Italy
Fundacio Assistencial Mutua de Terrassa

Barcelona, 08221, Spain
Georgios Papanikolaou General Hospital of Thessaloniki

Thessaloniki, 546 36, Greece
Helsinki University Hospital

Helsinki, Uusimaa, 00290, Finland
Horizon Clinical Research Group

Cypress, Texas, 77429, United States
Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain
Hospital Regional Universitario de Malaga - Hospital General

Málaga, 29010, Spain
Hospital Ruber Internacional (Grupo Quironsalud)

Madrid, 28034, Spain
Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain
Hospital Universitario Clínico San Cecilio

Granada, 18007, Spain
Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain
Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain
Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035, Spain
Hospital Universitario Virgen de Las Nieves

Granada, 18013, Spain
Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain
Hospital Vithas Granada

Granada, 18008, Spain
Hospital blua sanitas valdebebas

Madrid, 28055, Spain
Hospital da Luz Torres de Lisboa

Lisbon, 1600-209, Portugal
Hospital del Mar

Barcelona, 08003, Spain
IN MEDIC, s.r.o.

Bardejov, 085 01, Slovakia
IRCCS Istituto Neurologico Mediterraneo Neuromed

Pozzilli, Molise, 86077, Italy
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

Rome, 00165, Italy
Intermountain Health

Murray, Utah, 84107, United States
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

Genoa, Liguria, 16147, Italy
Jaslok Hospital and Research

Mumbai, 400026, India
John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom
Johns Hopkins University

Baltimore, Maryland, 21287, United States
King's College Hospital

London, SE5 9RS, United Kingdom
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh

Radeberg, Saxony, 01454, Germany
Klinikum Osnabrück GmbH

Osnabrück, Lower Saxony, 49076, Germany
Knight Neurology

Rockledge, Florida, 32955, United States
Krankenhaus Mara gGmbH

Bielefeld, North Rhine-Westphalia, 33617, Germany
Kraskova 2636, Neurologické oddelenie

Rimavská Sobota, 979 01, Slovakia
Kuopion yliopistollinen sairaala

Kuopio, Northern Savonia, 70200, Finland
LANDA Specjalistyczne

Krakow, 31-156, Poland
LSU Health Shreveport

Shreveport, Louisiana, 71103, United States
Las Mercedes Medical Research

Hialeah, Florida, 33012, United States
Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States
M3 Wake Research-Dallas

Dallas, Texas, 75246, United States
MTZ Clinical Research

Krakow, 02-172, Poland
MUSC

Charleston, South Carolina, 29425, United States
Mallikatta Neuro Centre

Mangalore, 575002, India
Medstar Health Research Institute

McLean, Virginia, 22101, United States
Montefiore Medical Center

The Bronx, New York, 10467, United States
Morriston Hospital

Swansea, Glamorgan, SA6 6NL, United Kingdom
NEREG

Hackensack, New Jersey, 07601, United States
NYU Langone Health

New York, New York, 10016, United States
Neurocare Of Louisiana

Covington, Louisiana, 70433, United States
Neurociencias Estudios Clinicos S.C.

Sinaloa, 80020, Mexico
Neurosphera SP. Z O.O

Warsaw, 02-829, Poland
Nizam's Insti. of Medical Sciences

Hyderabad, 500082, India
Northwell Health

Great Neck, New York, 11021, United States
Nova Clinical Research, LLC

Bradenton, Florida, 34209, United States
Odense Universitetshospital

Odense, Fyn, 5000, Denmark
Onyx Clinical Trials

Peoria, Arizona, 85381, United States
Oregon Neurology Associates

Springfield, Oregon, 97477, United States
Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy, 20132, Italy
Panhandle Research & Medical Clinic

Pensacola, Florida, 32502, United States
Pratia MCM Krakow

Krakow, 30-727, Poland
Premier Health

Dayton, Ohio, 45409, United States
Premium Clinic Wrocław

Wroclaw, 50-414, Poland
Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia
Profound Research LLC

Poway, California, 92065, United States
Queen Elizabeth University Hospital-PPDS

Glasgow, Glasgow City, G51 4TF, United Kingdom
Research Institute of Orlando

Orlando, Florida, 32806, United States
Royal Brisbane & Women's Hospital

Herston, Queensland, 4029, Australia
Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia
Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia
Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom
SRI International

Plymouth, Michigan, 48170, United States
Salford Royal Hospital - PPDS

Salford, Manchester, M6 8HD, United Kingdom
Semmel Egyet Idegsebésze Neuro Klin

Budapest, 1145, Hungary
Serenity Research Center

Miami, Florida, 33176, United States
Somnos Clinical Research

Lincoln, Nebraska, 68510, United States
St Georges NHS Foundation Trust

London, SW17 0QT, United Kingdom
St Vincents Hospital Melbourne - PPDS

Fitzroy, Victoria, 3065, Australia
Stryde Research

Plano, Texas, 75093, United States
Tampereen yliopistollinen sairaala

Tampere, Pirkanmaa, 33520, Finland
Tekton Research

Marlboro, New Jersey, 07746, United States
The Alfred Hospital

Melbourne, Victoria, 3004, Australia
The Royal London Hospital

London, WC1N 3HR, United Kingdom
Tri Valley Neurology Medical Associates, Inc.

Mission Hills, California, 91345, United States
UConn Health

Farmington, Connecticut, 06030, United States
ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião

Santa Maria da Feira, Aveiro District, 4520-211, Portugal
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

Lisbon, 1449-005, Portugal
ULS de Matosinhos, EPE - Hospital Pedro Hispano

Senhora da Hora, Porto District, 4454-509, Portugal
UTHSC

Houston, Texas, 77030, United States
UTHealth Houston

Houston, Texas, 77030, United States
Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city

Mexico City, 14050, Mexico
University General Hospital ''ATTIKON''

Chaïdári, 124 62, Greece
University General Hospital of Alexandroupolis

Alexandroupoli, 681 00, Greece
University Hospital of Wales

Cardiff, South Glamorgan, CF14 4XW, United Kingdom
University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States
University of Arizona / Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States
University of Missouri Health Care

Columbia, Missouri, 65212, United States
Università degli Studi G. D'Annunzio Chieti-Pescara

Chieti, Abruzzo, 66013, Italy
Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany
Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany
Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany
Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg

Marburg, Hesse, 35043, Germany
Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany
Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany
Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany
Vivantes - Humboldt Klinikum

Berlin, 13509, Germany
Xenoscience, Inc.

Phoenix, Arizona, 85004, United States
Y&L Advance Health Care, Inc d/b/a Elite Clinical Research

Miami, Florida, 33144, United States

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