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A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
SHINE
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
2 other identifiers
interventional
27
13 countries
103
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2024
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2024
CompletedFirst Posted
Study publicly available on registry
May 22, 2024
CompletedStudy Start
First participant enrolled
June 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2026
CompletedMarch 24, 2026
March 1, 2026
1.7 years
May 17, 2024
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week 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 Outcomes (3)
Percentage of Participants with freedom of GTC seizures during DBT Phase
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
Baseline to Week 24 of Double-Blind Treatment Period
Number of Participants With Clinically Significant Laboratory Abnormalities
Baseline to Week 24 of Double-Blind Treatment Period
Study Arms (2)
BHV-7000 75 mg
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (109)
Accel Research
Birmingham, Alabama, 35244, United States
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
ARENSIA Exploratory Medicine
Phoenix, Arizona, 85015, United States
Center for Neurosciences
Tucson, Arizona, 85718, United States
Profound Research LLC
Pasadena, California, 91105, United States
Medstar Health Research Institute
Washington D.C., District of Columbia, 20010, United States
Nova Clinical Research, LLC
Bradenton, Florida, 34209, United States
University of Florida (Jacksonville)
Jacksonville, Florida, 32209, United States
Y&L Advance Health Care,Inc d/b/a Elite Clinical Research
Miami, Florida, 33144, United States
Serenity Research Center
Miami, Florida, 33176, United States
Research Institute of Orlando
Orlando, Florida, 32806, United States
Comprehensive Neurology Clinic
Orlando, Florida, 32825, United States
Knight Neurology
Rockledge, Florida, 32955, United States
Santos Research Center
Tampa, Florida, 33615, United States
Encore Medical Research of Weston LLC.
Weston, Florida, 33331, United States
Augusta University
Augusta, Georgia, 30912, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817, United States
Consultants in Epilepsy & Neurology, PLLC (CEN)
Boise, Idaho, 83702, United States
Northwestern Medical Group, Department of Neurology
Chicago, Illinois, 60611, United States
Revive Research Institute, Inc.
Elgin, Illinois, 60123, United States
Bluegrass Epilepsy Research
Lexington, Kentucky, 40504, United States
OLOLRMC
Baton Rouge, Louisiana, 70808, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Somnos Clinical Research
Lincoln, Nebraska, 68510, United States
NEREG
Hackensack, New Jersey, 07601, United States
Institute of Neurology and Neurosurgery
Livingston, New Jersey, 07039, United States
Dent Neurosciences Research Center
Amherst, New York, 14226, United States
Boston Children's Health Physicians (BCHP)
Hawthorne, New York, 10532-1528, United States
Northwell Health Pediatric Neurology
New Hyde Park, New York, 11042, United States
NYU Langone Health
New York, New York, 10016, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
UPMC
Pittsburgh, Pennsylvania, 15213, United States
WR-ClinSearch
Chattanooga, Tennessee, 37421, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Neurology Consultants of Dallas, PA
Dallas, Texas, 75243, United States
ANESC Research
El Paso, Texas, 79912, United States
Road Runner Research, Ltd
San Antonio, Texas, 78249, United States
Intermountain Health
Murray, Utah, 84107, United States
Henrico Doctors' Neurology Associates, LLC
Richmond, Virginia, 23235, United States
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029, Australia
St Vincents Hospital Melbourne - PPDS
Fitzroy, Victoria, 3065, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Christian Doppler-Klinik - Universitätsklinikum der PMU
Salzburg, A-5020, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
UZ Antwerpen
Edegem, Antwerpen, 2650, Belgium
CHU UCL Namur - Site Godinne
Yvoir, Namur, 5530, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
Clinical Hospital Dubrava
Zagreb, City of Zagreb, 10000, Croatia
Clinical Hospital Sveti Duh
Zagreb, City of Zagreb, 10000, Croatia
Helsinki University Hospital
Helsinki, Uusimaa, 00290, Finland
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, Bas-Rhin, 67000, France
CHU Dijon Bourgogne
Dijon, Côte-d'Or, 21000, France
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
Toulouse, Haute-Garonne, 31059, France
CHRU Lille
Lille, Nord, 59037, France
Hospices Civils de Lyon - 59 Bd Pinel
Bron, Rhône, 69677, France
Hôpital Pontchaillou
Rennes, 35033, France
Epilepsiezentrum Kork
Kehl, Baden-Wurttemberg, 77694, Germany
Universitätsklinikum Ulm-Oberer Eselsberg 45
Ulm, Baden-Wurttemberg, 89081, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
LMU Klinikum der Universität München - Campus Großhadern
München, Bavaria, 81377, Germany
Klinikum der Johann-Wolfgang Goethe-Universitat - Schleusenweg 2-16
Frankfurt am Main, Hesse, 60528, Germany
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
Marburg, Hesse, 35043, Germany
Krankenhaus Mara gGmbH
Bielefeld, North Rhine-Westphalia, 33617, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
Radeberg, Saxony, 01454, Germany
Vivantes - Humboldt Klinikum
Berlin, 13509, Germany
Epilepsie-Zentrum Bodensee
Ravensburg, 88214, Germany
Ospedale Policlinico SS Annunziata - Chieti
Chieti, Abruzzo, 66013, Italy
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
Catanzaro, Calabria, 88100, Italy
AORN Antonio Cardarelli
Naples, Campania, 80131, Italy
AUSL di Bologna - Ospedale Bellaria
Bologna, Emilia-Romagna, 40139, Italy
IRCCS Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Isernia, 86077, Italy
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, 00133, Italy
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Rome, Lazio, 165, Italy
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genoa, Liguria, 16147, Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardy, 20132, Italy
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
Milan, Lombardy, 20142, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Lombardy, 27100, Italy
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Baggiovara, Modena, 41126, Italy
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Roma, 168, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, 37126, Italy
Kempenhaeghe - PPDS
Heeze, North Brabant, 5591 VE, Netherlands
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, 60-702, Poland
Pratia MCM KrakÛw
Krakow, Lesser Poland Voivodeship, 30-727, Poland
Twoja Przychodnia-Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
Santa Familia PTG Lodz
Lódz, Lódzkie, 90-302, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Neurosphera SP. Z O.O Warsaw
Warsaw, 02-829, Poland
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
Centro Clínico Académico, Braga - Hospital de Braga
Braga, 4710-243, Portugal
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, 3000-075, Portugal
Hospital da Luz Torres de Lisboa
Lisbon, 1600-209, Portugal
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 8916, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra, 36312, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga, 29010, Spain
Centro de Neurologia Avanzada
Seville, 41013, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47003, Spain
Neuroscience Research Centre
Fazakerley, L9 7LJ, United Kingdom
University College London Hospitals
London, WC1N 3HR, United Kingdom
Morriston Hospital
Morriston, SA6 6NL, United Kingdom
The Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Salford Royal Hospital
Salford, M6 8HD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2024
First Posted
May 22, 2024
Study Start
June 20, 2024
Primary Completion
March 12, 2026
Study Completion
March 12, 2026
Last Updated
March 24, 2026
Record last verified: 2026-03