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Epilepsy drug study halted early: BHV-7000 shows limited promise

NCT ID NCT06425159

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether BHV-7000, taken alongside other medications, could reduce generalized tonic-clonic seizures in people with idiopathic generalized epilepsy. The trial was terminated early and enrolled only 27 adults aged 18-75. The main goal was to see how long it took for a second seizure day to occur, but the early stop limits what can be concluded.

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

27 people

The number who actually took part.

Started

Jun 2024

Finished

Mar 2026

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.

Inclusion Criteria: * Male and Female participants 18 to 75 years of age at time of consent. * Diagnosis of Idiopathic Generalized Epilepsy at least 6 months prior to the screening visit, defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria. 1. Subject has probable GTC seizures in the setting of IGE, meaning GTC seizures and either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-wave on EEG and no focal abnormality (asymmetric spike-wave fragment is allowed) AND/OR a clear history of absence seizures or myoclonic jerks 2. Subjects with possible GTC seizures in the setting of IGE, meaning GTC and either Normal EEG OR Generalized epileptiform EEG abnormality with atypical spike-wave and no focal abnormality (asymmetric spike-wave fragment is allowed). * Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom. * Ability of subject or caregiver to keep accurate seizure diaries * Current treatment with at least 1 to 3 ASMs as part of no more than 4 epilepsy treatments in total (e.g., each ASM is considered 1 treatment. Other epilepsy therapies including devices and diet therapy are allowed; together these other therapies count as 1 treatment). * Accurate history of having at least 3 days with a GTC seizure evenly spread throughout the 16 weeks prior to the screening visit, such that a subject had at least 1 day with a GTC seizure during the first 8 weeks and at least 1 day with a GTC seizure during the second 8 weeks. Exclusion Criteria: * History of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired conscious 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 GTC seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having repetitive/cluster GTC seizures count during the screening phase. * Any condition that would interfere with 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.

As listed by the trial registrant

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

Contacts and locations

Locations

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

    Poznan, Greater Poland Voivodeship, 60-702, Poland

  • 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, 40139, Italy

  • Accel Research

    Birmingham, Alabama, 35244, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, 37126, Italy

  • Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini

    Catanzaro, Calabria, 88100, Italy

  • Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara

    Baggiovara, Modena, 41126, Italy

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • Bluegrass Epilepsy Research

    Lexington, Kentucky, 40504, United States

  • Boston Children's Health Physicians (BCHP)

    Hawthorne, New York, 10532-1528, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • CHRU Lille

    Lille, Nord, 59037, France

  • CHU Dijon Bourgogne

    Dijon, Côte-d'Or, 21000, France

  • CHU UCL Namur - Site Godinne

    Yvoir, Namur, 5530, Belgium

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, Bas-Rhin, 67000, France

  • CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan

    Toulouse, Haute-Garonne, 31059, France

  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, Pontevedra, 36312, Spain

  • Center for Neurosciences

    Tucson, Arizona, 85718, United States

  • Centro Clínico Académico, Braga - Hospital de Braga

    Braga, 4710-243, Portugal

  • Centro de Neurologia Avanzada

    Seville, 41013, Spain

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Christian Doppler-Klinik - Universitätsklinikum der PMU

    Salzburg, A-5020, Austria

  • Clinical Hospital Dubrava

    Zagreb, City of Zagreb, 10000, Croatia

  • Clinical Hospital Sveti Duh

    Zagreb, City of Zagreb, 10000, Croatia

  • Comprehensive Neurology Clinic

    Orlando, Florida, 32825, United States

  • Consultants in Epilepsy & Neurology, PLLC (CEN)

    Boise, Idaho, 83702, United States

  • Dent Neurosciences Research Center

    Amherst, New York, 14226, United States

  • Encore Medical Research of Weston LLC.

    Weston, Florida, 33331, United States

  • Epilepsie-Zentrum Bodensee

    Ravensburg, 88214, Germany

  • Epilepsiezentrum Kork

    Kehl, Baden-Wurttemberg, 77694, Germany

  • 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 - PPDS

    Roma, 168, Italy

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817, United States

  • Helsinki University Hospital

    Helsinki, Uusimaa, 00290, Finland

  • Henrico Doctors' Neurology Associates, LLC

    Richmond, Virginia, 23235, United States

  • Hospices Civils de Lyon - 59 Bd Pinel

    Bron, Rhône, 69677, France

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003, Spain

  • Hospital Regional Universitario de Malaga - Hospital General

    Málaga, 29010, Spain

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 8916, Spain

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital da Luz Torres de Lisboa

    Lisbon, 1600-209, Portugal

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hôpital Pontchaillou

    Rennes, 35033, France

  • IRCCS Istituto Neurologico Mediterraneo Neuromed

    Pozzilli, Isernia, 86077, Italy

  • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

    Rome, Lazio, 165, Italy

  • Institute of Neurology and Neurosurgery

    Livingston, New Jersey, 07039, United States

  • Intermountain Health

    Murray, Utah, 84107, United States

  • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

    Genoa, Liguria, 16147, Italy

  • Kempenhaeghe - PPDS

    Heeze, North Brabant, 5591 VE, Netherlands

  • Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh

    Radeberg, Saxony, 01454, Germany

  • Klinikum der Johann-Wolfgang Goethe-Universitat - Schleusenweg 2-16

    Frankfurt am Main, Hesse, 60528, Germany

  • Knight Neurology

    Rockledge, Florida, 32955, United States

  • Krankenhaus Mara gGmbH

    Bielefeld, North Rhine-Westphalia, 33617, Germany

  • LMU Klinikum der Universität München - Campus Großhadern

    München, Bavaria, 81377, Germany

  • Medizinische Universität Wien

    Vienna, 1090, Austria

  • Medstar Health Research Institute

    Washington D.C., District of Columbia, 20010, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Morriston Hospital

    Morriston, SA6 6NL, United Kingdom

  • NEREG

    Hackensack, New Jersey, 07601, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Neurology Consultants of Dallas, PA

    Dallas, Texas, 75243, United States

  • Neuroscience Research Centre

    Fazakerley, L9 7LJ, United Kingdom

  • Neurosphera SP. Z O.O Warsaw

    Warsaw, 02-829, Poland

  • Northwell Health Pediatric Neurology

    New Hyde Park, New York, 11042, United States

  • Northwestern Medical Group, Department of Neurology

    Chicago, Illinois, 60611, United States

  • Nova Clinical Research, LLC

    Bradenton, Florida, 34209, United States

  • OLOLRMC

    Baton Rouge, Louisiana, 70808, United States

  • Ospedale Policlinico SS Annunziata - Chieti

    Chieti, Abruzzo, 66013, Italy

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, Lombardy, 20132, Italy

  • Pratia MCM KrakÛw

    Krakow, Lesser Poland Voivodeship, 30-727, Poland

  • Profound Research LLC

    Pasadena, California, 91105, United States

  • Research Institute of Orlando

    Orlando, Florida, 32806, United States

  • Revive Research Institute, Inc.

    Elgin, Illinois, 60123, United States

  • Road Runner Research, Ltd

    San Antonio, Texas, 78249, United States

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029, Australia

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • Salford Royal Hospital

    Salford, M6 8HD, United Kingdom

  • Santa Familia PTG Lodz

    Lódz, Lódzkie, 90-302, Poland

  • Santos Research Center

    Tampa, Florida, 33615, United States

  • Serenity Research Center

    Miami, Florida, 33176, United States

  • Somnos Clinical Research

    Lincoln, Nebraska, 68510, United States

  • St Vincents Hospital Melbourne - PPDS

    Fitzroy, Victoria, 3065, Australia

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Twoja Przychodnia-Centrum Medyczne Nowa Sol

    Nowa Sól, Lubusz Voivodeship, 67-100, Poland

  • ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra

    Coimbra, 3000-075, Portugal

  • ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião

    Santa Maria da Feira, Aveiro District, 4520-211, Portugal

  • ULS de Matosinhos, EPE - Hospital Pedro Hispano

    Senhora da Hora, Porto District, 4464-513, Portugal

  • UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • UZ Antwerpen

    Edegem, Antwerpen, 2650, Belgium

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • University College London Hospitals

    London, WC1N 3HR, United Kingdom

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112, United States

  • University of Florida (Jacksonville)

    Jacksonville, Florida, 32209, United States

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitätsklinikum Erlangen

    Erlangen, Bavaria, 91054, Germany

  • Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg

    Marburg, Hesse, 35043, Germany

  • Universitätsklinikum Ulm-Oberer Eselsberg 45

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Vivantes - Humboldt Klinikum

    Berlin, 13509, Germany

  • WR-ClinSearch

    Chattanooga, Tennessee, 37421, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Y&L Advance Health Care,Inc d/b/a Elite Clinical Research

    Miami, Florida, 33144, United States