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

March 20, 2026 updated by: Biohaven Therapeutics Ltd.

A Phase 2/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures, With Open-label Extension

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane & Women's Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincents Hospital Melbourne - PPDS
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Austria
      • Salzburg, Austria, A-5020
        • Christian Doppler-Klinik - Universitätsklinikum der PMU
      • Vienna, Austria, 1090
        • Medizinische Universität Wien
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • UZ Antwerpen
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • CHU UCL Namur - Site Godinne
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent
  • Croatia
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Clinical Hospital Dubrava
      • Zagreb, City of Zagreb, Croatia, 10000
        • Clinical Hospital Sveti Duh
  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Helsinki University Hospital
  • France
      • Rennes, France, 35033
        • Hôpital Pontchaillou
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67000
        • CHU de Strasbourg - Hôpital de Hautepierre
    • Côte-d'Or
      • Dijon, Côte-d'Or, France, 21000
        • CHU Dijon Bourgogne
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
    • Nord
      • Lille, Nord, France, 59037
        • CHRU Lille
    • Rhône
      • Bron, Rhône, France, 69677
        • Hospices Civils de Lyon - 59 Bd Pinel
  • Germany
      • Berlin, Germany, 13509
        • Vivantes - Humboldt Klinikum
      • Ravensburg, Germany, 88214
        • Epilepsie-Zentrum Bodensee
    • Baden-Wurttemberg
      • Kehl, Baden-Wurttemberg, Germany, 77694
        • Epilepsiezentrum Kork
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Universitätsklinikum Ulm-Oberer Eselsberg 45
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Universitätsklinikum Erlangen
      • München, Bavaria, Germany, 81377
        • LMU Klinikum der Universität München - Campus Großhadern
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60528
        • Klinikum der Johann-Wolfgang Goethe-Universitat - Schleusenweg 2-16
      • Marburg, Hesse, Germany, 35043
        • Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
    • North Rhine-Westphalia
      • Bielefeld, North Rhine-Westphalia, Germany, 33617
        • Krankenhaus Mara gGmbH
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Universitätsklinikum Bonn
    • Saxony
      • Radeberg, Saxony, Germany, 01454
        • Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh
  • Italy
      • Roma, Italy, 168
        • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
      • Verona, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata Di Verona
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66013
        • Ospedale Policlinico SS Annunziata - Chieti
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
    • Campania
      • Naples, Campania, Italy, 80131
        • AORN Antonio Cardarelli
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40139
        • AUSL di Bologna - Ospedale Bellaria
    • Isernia
      • Pozzilli, Isernia, Italy, 86077
        • IRCCS Istituto Neurologico Mediterraneo Neuromed
    • Lazio
      • Rome, Lazio, Italy, 00133
        • Fondazione PTV Policlinico Tor Vergata
      • Rome, Lazio, Italy, 165
        • IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN
    • Liguria
      • Genoa, Liguria, Italy, 16147
        • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Ospedale San Raffaele S.r.l. - PPDS
      • Milan, Lombardy, Italy, 20142
        • ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
      • Pavia, Lombardy, Italy, 27100
        • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
    • Modena
      • Baggiovara, Modena, Italy, 41126
        • Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
  • Netherlands
    • North Brabant
      • Heeze, North Brabant, Netherlands, 5591 VE
        • Kempenhaeghe - PPDS
  • Poland
      • Warsaw, Poland, 02-829
        • Neurosphera SP. Z O.O Warsaw
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-702
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Pratia MCM KrakÛw
    • Lubusz Voivodeship
      • Nowa Sól, Lubusz Voivodeship, Poland, 67-100
        • Twoja Przychodnia-Centrum Medyczne Nowa Sol
    • Lódzkie
      • Lódz, Lódzkie, Poland, 90-302
        • Santa Familia PTG Lodz
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Portugal
      • Braga, Portugal, 4710-243
        • Centro Clínico Académico, Braga - Hospital de Braga
      • Coimbra, Portugal, 3000-075
        • ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
      • Lisbon, Portugal, 1600-209
        • Hospital da Luz Torres de Lisboa
    • Aveiro District
      • Santa Maria da Feira, Aveiro District, Portugal, 4520-211
        • ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
    • Porto District
      • Senhora da Hora, Porto District, Portugal, 4464-513
        • ULS de Matosinhos, EPE - Hospital Pedro Hispano
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Malaga - Hospital General
      • Seville, Spain, 41013
        • Centro de Neurologia Avanzada
      • Valladolid, Spain, 47003
        • Hospital Clínico Universitario de Valladolid
    • Barcelona
      • Badalona, Barcelona, Spain, 8916
        • Hospital Universitario Germans Trias i Pujol
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • CHUVI - H.U. Alvaro Cunqueiro
  • United Kingdom
      • Fazakerley, United Kingdom, L9 7LJ
        • Neuroscience Research Centre
      • London, United Kingdom, WC1N 3HR
        • University College London Hospitals
      • Morriston, United Kingdom, SA6 6NL
        • Morriston Hospital
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • The Royal Victoria Infirmary
      • Salford, United Kingdom, M6 8HD
        • Salford Royal Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Accel Research
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
      • Phoenix, Arizona, United States, 85015
        • ARENSIA Exploratory Medicine
      • Tucson, Arizona, United States, 85718
        • Center For Neurosciences
    • California
      • Pasadena, California, United States, 91105
        • Profound Research LLC
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Medstar Health Research Institute
    • Florida
      • Bradenton, Florida, United States, 34209
        • Nova Clinical Research, LLC
      • Jacksonville, Florida, United States, 32209
        • University of Florida (Jacksonville)
      • Miami, Florida, United States, 33176
        • Serenity Research Center
      • Miami, Florida, United States, 33144
        • Y&L Advance Health Care,Inc d/b/a Elite Clinical Research
      • Orlando, Florida, United States, 32806
        • Research Institute of Orlando
      • Orlando, Florida, United States, 32825
        • Comprehensive Neurology Clinic
      • Rockledge, Florida, United States, 32955
        • Knight Neurology
      • Tampa, Florida, United States, 33615
        • Santos Research Center
      • Weston, Florida, United States, 33331
        • Encore Medical Research of Weston LLC.
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Pacific Neuroscience
    • Idaho
      • Boise, Idaho, United States, 83702
        • Consultants in Epilepsy & Neurology, PLLC (CEN)
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Group, Department of Neurology
      • Elgin, Illinois, United States, 60123
        • Revive Research Institute, Inc.
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Bluegrass Epilepsy Research
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • OLOLRMC
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Boston Clinical Trials
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Somnos Clinical Research
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • NEREG
      • Livingston, New Jersey, United States, 07039
        • Institute of Neurology and Neurosurgery
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurosciences Research Center
      • Hawthorne, New York, United States, 10532-1528
        • Boston Children's Health Physicians (BCHP)
      • New Hyde Park, New York, United States, 11042
        • Northwell Health Pediatric Neurology
      • New York, New York, United States, 10016
        • NYU Langone Health
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • WR-ClinSearch
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75243
        • Neurology Consultants of Dallas, PA
      • El Paso, Texas, United States, 79912
        • ANESC Research
      • San Antonio, Texas, United States, 78249
        • Road Runner Research, Ltd
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Health
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Henrico Doctors' Neurology Associates, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Matching placebo taken once daily
Active Comparator: BHV-7000 75 mg
Drug: BHV-7000
BHV-7000 75mg. Participants will take blinded investigational product (IP) once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period
Time Frame: Baseline to Week 24 of Double-Blind Treatment Period
To compare the efficacy of BHV-7000 to placebo as adjunctive therapy for subjects with idiopathic generalized epilepsy with generalized tonic-clonic (GTC) seizures as measured by the time to the second day with a GTC seizure during the double-blind phase
Baseline to Week 24 of Double-Blind Treatment Period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with freedom of GTC seizures during DBT Phase
Time Frame: Baseline to Week 24 of Double-Blind Treatment Period
To compare the efficacy of BHV-7000 to placebo in terms of the proportion of subjects that are free of GTC seizures as measured by the proportion of subjects with GTC seizure freedom during the 24-week DBP, estimated using Kaplan- Meier methods.
Baseline to Week 24 of Double-Blind Treatment Period
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Time Frame: Baseline to Week 24 of Double-Blind Treatment Period
To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs
Baseline to Week 24 of Double-Blind Treatment Period
Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame: Baseline to Week 24 of Double-Blind Treatment Period
To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with grade 3 and grade 4 laboratory abnormalities.
Baseline to Week 24 of Double-Blind Treatment Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biohaven Therapeutics Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2024

Primary Completion (Actual)

March 12, 2026

Study Completion (Actual)

March 12, 2026

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHV7000-304
  • 2023-508812-45-00 (Other Identifier: EU CTR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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