Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

Last updated: April 9, 2025
Sponsor: Biohaven Therapeutics Ltd.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Epilepsy

Treatment

BHV-7000

Placebo

Clinical Study ID

NCT06309966
BHV7000-303
2023-808811-21-00
2023-808811-21
2023-508811-21
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Eligibility Criteria

Inclusion

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 definedby 2017 International League Against Epilepsy (ILAE) Classification and based onrequirements of Epilepsy Adjudication criteria. a. Focal seizures i. Focal aware seizures with clinically observable signs and/orsymptoms ii. Focal impaired awareness seizures with clinically observable signsand/or symptoms iii. Focal to bilateral tonic-clonic seizures

  3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure ofadequate trials of two tolerated and appropriately chosen and used anti-seizuremedication (ASM) schedules (whether as monotherapies or in combination) to achievesustained 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 intotal

Exclusion

Key Exclusion Criteria:

  1. History of status epilepticus (convulsive status epilepticus for > 5 minutes orfocal status epilepticus with impaired consciousness for > 10 minutes) within thelast 6 months prior to screening visit that is not consistent with the subject'shabitual 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 orpsychic phenomena only, without impairment of consciousness or awareness (formallycalled simple partial seizures), with or without ictal EEG correlation with clinicalsymptoms.

  6. Any condition that would interfere with the subject's ability to comply with studyinstructions, place the subject at unacceptable risk, and/or confound theinterpretation of safety or efficacy data from the study, as judged by theInvestigator

Study Design

Total Participants: 390
Treatment Group(s): 2
Primary Treatment: BHV-7000
Phase: 2/3
Study Start date:
May 13, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Royal Brisbane & Women's Hospital

    Herston, Queensland 4029
    Australia

    Site Not Available

  • St Vincents Hospital Melbourne - PPDS

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Austin Hospital

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • Odense Universitetshospital

    Odense, Fyn 5000
    Denmark

    Active - Recruiting

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa 33520
    Finland

    Active - Recruiting

  • Kuopion yliopistollinen sairaala

    Kuopio, Pohjois-Savo 70200
    Finland

    Active - Recruiting

  • Helsinki University Hospital

    Helsinki, Uusimaa 00290
    Finland

    Active - Recruiting

  • Universitätsklinikum Freiburg

    Freiburg, Baden-Württemberg 79106
    Germany

    Site Not Available

  • Epilepsiezentrum Kork

    Kehl, Baden-Württemberg 77694
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm

    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

  • Epilepsieklinik Tabor

    Bernau bei Berlin, Brandenburg 16321
    Germany

    Site Not Available

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

    Frankfurt am Main, Hessen 60528
    Germany

    Active - Recruiting

  • Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg

    Marburg, Hessen 35043
    Germany

    Site Not Available

  • Klinikum Osnabrück GmbH

    Osnabrück, Niedersachsen 49076
    Germany

    Active - Recruiting

  • Krankenhaus Mara gGmbH

    Bielefeld, Nordrhein-Westfalen 33617
    Germany

    Active - Recruiting

  • Universitätsklinikum Bonn

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig

    Leipzig, Sachsen 04103
    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

  • Università degli Studi G. D'Annunzio Chieti-Pescara

    Chieti, Abruzzo 66013
    Italy

    Active - Recruiting

  • 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 40123
    Italy

    Active - Recruiting

  • Fondazione PTV Policlinico Tor Vergata

    Roma, Lazio 00133
    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

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milano, Lombardia 20133
    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

  • Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Ancona, Marche 60121
    Italy

    Active - Recruiting

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

    Baggiovara, Modena 41126
    Italy

    Active - Recruiting

  • IRCCS Istituto Neurologico Mediterraneo Neuromed

    Pozzilli, Molise 86077
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

    Calambrone, Toscana 56018
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario A Gemelli-Rome

    Roma, 00168
    Italy

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

    Rome, 00165
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, 37126
    Italy

    Active - Recruiting

  • 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 4454-509
    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, 3000-459
    Portugal

    Active - Recruiting

  • Hospital da Luz Torres de Lisboa

    Lisboa, 1600-209
    Portugal

    Active - Recruiting

  • ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

    Lisboa, 1449-005
    Portugal

    Active - Recruiting

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • Hospital Universitario de Bellvitge

    L'Hospitalet De Llobregat, Barcelona 08907
    Spain

    Active - Recruiting

  • Hospital Universitario de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, Pontevedra 36312
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Universitario Clínico San Cecilio

    Granada, 18007
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18013
    Spain

    Active - Recruiting

  • Hospital Vithas Granada

    Granada, 18008
    Spain

    Active - Recruiting

  • Hospital Ruber Internacional (Grupo Quironsalud)

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    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 Universitari i Politecnic La Fe de Valencia

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

  • Morriston Hospital

    Swansea, Glamorgan SA6 6NL
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth University Hospital-PPDS

    Glasgow, Glasgow City G51 4TF
    United Kingdom

    Active - Recruiting

  • Salford Royal Hospital - PPDS

    Salford, Manchester M6 8HD
    United Kingdom

    Active - Recruiting

  • The Walton Centre - PPDS

    Liverpool, Merseyside L9 7LJ
    United Kingdom

    Active - Recruiting

  • University College London Hospitals (UCLH)

    London, Middlesex NW1 2PG
    United Kingdom

    Active - Recruiting

  • University Hospital of Wales

    Cardiff, South Glamorgan CF14 4XW
    United Kingdom

    Active - Recruiting

  • Royal Victoria Infirmary

    Newcastle Upon Tyne, NE1 4LP
    United Kingdom

    Active - Recruiting

  • Accel Research

    Birmingham, Alabama 35244
    United States

    Active - Recruiting

  • ARENSIA Exploratory Medicine

    Phoenix, Arizona 85015
    United States

    Active - Recruiting

  • Xenoscience, Inc.

    Phoenix, Arizona 85004
    United States

    Active - Recruiting

  • Amicis Research Center

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Memorialcare Miller Children's & Women's Hospital Long Beach

    Long Beach, California 90806
    United States

    Active - Recruiting

  • Profound Research LLC

    Poway, California 92065
    United States

    Active - Recruiting

  • Kaiser Permanente

    Aurora, Colorado 80011
    United States

    Active - Recruiting

  • UConn Health

    Farmington, Connecticut 06030
    United States

    Active - Recruiting

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Medstar Health Research Institute

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Dm Healthworks

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • 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

    Active - Recruiting

  • Research Institute of Orlando

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Knight Neurology

    Rockledge, Florida 32955
    United States

    Active - Recruiting

  • PENS

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • DelRicht Research

    Baton Rouge, Louisiana 70810
    United States

    Active - Recruiting

  • OLORMC

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

  • DelRicht Research

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • University Medical Center New Orleans

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • LSU Health Shreveport

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Active - Recruiting

  • Somnos Clinical Research

    Lincoln, Nebraska 68510
    United States

    Active - Recruiting

  • Northwell Health

    Great Neck, New York 11021
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • UNC-Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Cincinatti Children's Hospital

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • AHN

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • MUSC

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • WR-ClinSearch

    Chattanooga, Tennessee 37421
    United States

    Active - Recruiting

  • Le Bonheur Children's Hospital

    Memphis, Tennessee 38103
    United States

    Active - Recruiting

  • ANESC Research

    El Paso, Texas 79912
    United States

    Active - Recruiting

  • UTHealth Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Intermountain Health

    Murray, Utah 84107
    United States

    Active - Recruiting

  • Medstar Health Research Institute

    McLean, Virginia 22101
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.