A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures

Last updated: April 7, 2025
Sponsor: Biohaven Therapeutics Ltd.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Epilepsy

Epilepsy (Pediatric)

Seizure Disorders

Treatment

BHV-7000

Placebo

Clinical Study ID

NCT06425159
BHV7000-304
2023-508812-45-00
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase.

Eligibility Criteria

Inclusion

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 thescreening 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 seizuresand either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-waveon 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 andeither Normal EEG OR Generalized epileptiform EEG abnormality with atypicalspike-wave and no focal abnormality (asymmetric spike-wave fragment isallowed).

  • Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure ofadequate 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 epilepsytreatments in total (e.g., each ASM is considered 1 treatment. Other epilepsytherapies including devices and diet therapy are allowed; together these othertherapies count as 1 treatment).

  • Accurate history of having at least 3 days with a GTC seizure evenly spreadthroughout the 16 weeks prior to the screening visit, such that a subject had atleast 1 day with a GTC seizure during the first 8 weeks and at least 1 day with aGTC seizure during the second 8 weeks.

Exclusion

Exclusion Criteria:

  • History of status epilepticus (convulsive status epilepticus for > 5 minutes orfocal status epilepticus with impaired conscious for > 10 minutes) within the last 6months prior to screening visit that is not consistent with the subject's habitualseizure.

  • History of repetitive/cluster GTC seizures (where individual seizures cannot becounted) within the last 6 months prior to screening visit, or havingrepetitive/cluster GTC seizures count during the screening phase.

  • Any condition that would interfere with and/or confound the interpretation of safetyor efficacy data from the study, as judged by the Investigator

Study Design

Total Participants: 242
Treatment Group(s): 2
Primary Treatment: BHV-7000
Phase: 2/3
Study Start date:
June 20, 2024
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Royal Brisbane & Women's Hospital

    Herston, Queensland 4029
    Australia

    Site Not Available

  • St Vincents Hospital Melbourne - PPDS

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Austin Hospital

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • Christian Doppler-Klinik - Universitätsklinikum der PMU

    Salzburg, A-5020
    Austria

    Active - Recruiting

  • Medizinische Universität Wien

    Wien, 1090
    Austria

    Active - Recruiting

  • UZ Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • Clinical Hospital Dubrava

    Zagreb, Grad Zagreb 10000
    Croatia

    Site Not Available

  • Clinical Hospital Sveti Duh

    Zagreb, Grad Zagreb 10000
    Croatia

    Active - Recruiting

  • Helsinki University Hospital

    Helsinki, Uusimaa 00290
    Finland

    Active - Recruiting

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, Bas-Rhin 67000
    France

    Active - Recruiting

  • CHU Dijon Bourgogne

    Dijon, Côte-d'Or 21000
    France

    Active - Recruiting

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

    Toulouse, Haute-Garonne 31059
    France

    Active - Recruiting

  • CHRU Lille

    Lille Cedex, Nord 59037
    France

    Active - Recruiting

  • Hospices Civils de Lyon - 59 Bd Pinel

    Bron, Rhône 69677
    France

    Active - Recruiting

  • Hôpital Pontchaillou

    Rennes, 35033
    France

    Active - Recruiting

  • Epilepsiezentrum Kork

    Kehl, Baden-Württemberg 77694
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm-Oberer Eselsberg 45

    Ulm, Baden-Württemberg 89081
    Germany

    Active - Recruiting

  • Universitätsklinikum Erlangen

    Erlangen, Bayern 91054
    Germany

    Active - Recruiting

  • LMU Klinikum der Universität München - Campus Großhadern

    München, Bayern 81377
    Germany

    Active - Recruiting

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

    Frankfurt am Main, Hessen 60528
    Germany

    Active - Recruiting

  • Krankenhaus Mara gGmbH

    Bielefeld, Nordrhein-Westfalen 33617
    Germany

    Active - Recruiting

  • Universitätsklinikum Bonn

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Active - Recruiting

  • Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh

    Radeberg, Sachsen 01454
    Germany

    Active - Recruiting

  • Vivantes - Humboldt Klinikum

    Berlin, 13509
    Germany

    Active - Recruiting

  • Epilepsie-Zentrum Bodensee

    Ravensburg, 88214
    Germany

    Site Not Available

  • Ospedale Policlinico SS Annunziata - Chieti

    Chieti, Abruzzo 66013
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini

    Catanzaro, Calabria 88100
    Italy

    Active - Recruiting

  • AORN Antonio Cardarelli

    Napoli, Campania 80131
    Italy

    Active - Recruiting

  • AUSL di Bologna - Ospedale Bellaria

    Bologna, Emilia-Romagna 40139
    Italy

    Active - Recruiting

  • IRCCS Istituto Neurologico Mediterraneo Neuromed

    Pozzilli, Isernia 86077
    Italy

    Active - Recruiting

  • Fondazione PTV Policlinico Tor Vergata

    Roma, Lazio 00133
    Italy

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

    Roma, Lazio 165
    Italy

    Active - Recruiting

  • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

    Genova, Liguria 16147
    Italy

    Active - Recruiting

  • ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo

    Milano, Lombardia 20142
    Italy

    Active - Recruiting

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

    Milano, Lombardia 20132
    Italy

    Active - Recruiting

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

    Pavia, Lombardia 27100
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

    Roma, 168
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, 37126
    Italy

    Active - Recruiting

  • Kempenhaeghe - PPDS

    Heeze, Noord-Brabant 5591 VE
    Netherlands

    Active - Recruiting

  • Twoja Przychodnia-Centrum Medyczne Nowa Sol

    Nowa Sol, Lubuskie 67-100
    Poland

    Active - Recruiting

  • Santa Familia PTG Lodz

    Lódz, Lódzkie 90-302
    Poland

    Active - Recruiting

  • Pratia MCM KrakÛw

    Kraków, Malopolskie 30-727
    Poland

    Active - Recruiting

  • Retrieving data. Wait a few seconds and try to cut or copy again.

    Kraków, Malopolskie 30-727
    Poland

    Active - Recruiting

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

    Gdańsk, Pomorskie 80-546
    Poland

    Active - Recruiting

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

    Poznań, Wielkopolskie 60-702
    Poland

    Active - Recruiting

  • Neurosphera SP. Z O.O Warsaw

    Warszawa, 02-829
    Poland

    Site Not Available

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

    Santa Maria Da Feira, Aveiro 4520-211
    Portugal

    Active - Recruiting

  • ULS de Matosinhos, EPE - Hospital Pedro Hispano

    Senhora Da Hora, Porto 4464-513
    Portugal

    Active - Recruiting

  • Centro Clínico Académico, Braga - Hospital de Braga

    Braga, 4710-243
    Portugal

    Active - Recruiting

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

    Coimbra, 3000-075
    Portugal

    Active - Recruiting

  • Hospital da Luz Torres de Lisboa

    Lisboa, 1600-209
    Portugal

    Active - Recruiting

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona 8916
    Spain

    Active - Recruiting

  • Hospital Universitario de Bellvitge

    L'Hospitalet De Llobregat, Barcelona 08907
    Spain

    Active - Recruiting

  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, Pontevedra 36312
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Malaga - Hospital General

    Málaga, 29010
    Spain

    Active - Recruiting

  • Centro de Neurologia Avanzada

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

  • Accel Research

    Birmingham, Alabama 35244
    United States

    Active - Recruiting

  • ARENSIA Exploratory Medicine

    Phoenix, Arizona 85015
    United States

    Active - Recruiting

  • Barrow Neurological Institute

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • Center for Neurosciences

    Tucson, Arizona 85718
    United States

    Active - Recruiting

  • WRN

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Amicis Research Center

    Lancaster, California 93534
    United States

    Site Not Available

  • Profound Research LLC

    Pasadena, California 91105
    United States

    Active - Recruiting

  • Medstar Health Research Institute

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Nova Clinical Research, LLC

    Bradenton, Florida 34209
    United States

    Active - Recruiting

  • University of Florida (Jacksonville)

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • Floridian Research Institute

    Miami, Florida 33179
    United States

    Active - Recruiting

  • Serenity Research Center

    Miami, Florida 33176
    United States

    Active - Recruiting

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

    Miami, Florida 33144
    United States

    Active - Recruiting

  • Comprehensive Neurology Clinic

    Orlando, Florida 32825
    United States

    Site Not Available

  • Research Institute of Orlando

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Knight Neurology

    Rockledge, Florida 32955
    United States

    Active - Recruiting

  • Santos Research Center

    Tampa, Florida 33615
    United States

    Active - Recruiting

  • Encore Medical Research of Weston LLC.

    Weston, Florida 33331
    United States

    Active - Recruiting

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • Consultants in Epilepsy & Neurology, PLLC (CEN)

    Boise, Idaho 83702
    United States

    Active - Recruiting

  • Northwestern

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northwestern Medical Group, Department of Neurology

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Revive Research Institute, Inc.

    Elgin, Illinois 60123
    United States

    Site Not Available

  • Bluegrass Epilepsy Research

    Lexington, Kentucky 40504
    United States

    Active - Recruiting

  • OLOLRMC

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • University Medical Center New Orleans

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Active - Recruiting

  • Revive Research Institute, Inc.

    Rochester Hills, Michigan 48307
    United States

    Site Not Available

  • Somnos Clinical Research

    Lincoln, Nebraska 68510
    United States

    Active - Recruiting

  • NEREG

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Inst of Neurology

    Livingston, New Jersey 07039
    United States

    Active - Recruiting

  • Institute of Neurology and Neurosurgery

    Livingston, New Jersey 07039
    United States

    Active - Recruiting

  • Dent Neurosciences Research Center

    Amherst, New York 14226
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Northwell Health Pediatric Neurology

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • OnSite Clinical Solutions

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • WR-ClinSearch

    Chattanooga, Tennessee 37421
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Clinical Research Solution LLC

    Cypress, Texas 77429
    United States

    Site Not Available

  • Neurology Consultants of Dallas, PA

    Dallas, Texas 75243
    United States

    Active - Recruiting

  • ANESC Research

    El Paso, Texas 79912
    United States

    Active - Recruiting

  • UTHealth Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Road Runner Research, Ltd

    San Antonio, Texas 78249
    United States

    Active - Recruiting

  • Intermountain Health

    Murray, Utah 84107
    United States

    Site Not Available

  • Henrico Doctors' Neurology Associates, LLC

    Richmond, Virginia 23235
    United States

    Active - Recruiting

  • Henrico Doctors'Neurology Associates, LLC

    Richmond, Virginia 23235
    United States

    Active - Recruiting

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