A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
- Registration Number
- NCT06425159
- Lead Sponsor
- Biohaven Therapeutics Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 242
-
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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - BHV-7000 75 mg BHV-7000 -
- Primary Outcome Measures
Name Time Method Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period 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
- Secondary Outcome Measures
Name Time Method Percentage of Participants with freedom of GTC seizures during DBT Phase 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.
Number of Participants With Clinically Significant Laboratory Abnormalities 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.
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 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
Trial Locations
- Locations (105)
Hรดpital Pontchaillou
๐ซ๐ทRennes, France
Accel Research
๐บ๐ธBirmingham, Alabama, United States
Barrow Neurological Institute
๐บ๐ธPhoenix, Arizona, United States
ARENSIA Exploratory Medicine
๐บ๐ธPhoenix, Arizona, United States
Center for Neurosciences
๐บ๐ธTucson, Arizona, United States
WRN
๐บ๐ธRogers, Arkansas, United States
Amicis Research Center
๐บ๐ธLancaster, California, United States
Profound Research LLC
๐บ๐ธPasadena, California, United States
Medstar Health Research Institute
๐บ๐ธWashington, District of Columbia, United States
Nova Clinical Research, LLC
๐บ๐ธBradenton, Florida, United States
University of Florida (Jacksonville)
๐บ๐ธJacksonville, Florida, United States
Santa Familia PTG Lodz
๐ต๐ฑLรณdz, Lรณdzkie, Poland
Y&L Advance Health Care,Inc d/b/a Elite Clinical Research
๐บ๐ธMiami, Florida, United States
Serenity Research Center
๐บ๐ธMiami, Florida, United States
Floridian Research Institute
๐บ๐ธMiami, Florida, United States
Research Institute of Orlando
๐บ๐ธOrlando, Florida, United States
Comprehensive Neurology Clinic
๐บ๐ธOrlando, Florida, United States
Knight Neurology
๐บ๐ธRockledge, Florida, United States
Santos Research Center
๐บ๐ธTampa, Florida, United States
Encore Medical Research of Weston LLC.
๐บ๐ธWeston, Florida, United States
Hawaii Pacific Neuroscience
๐บ๐ธHonolulu, Hawaii, United States
Consultants in Epilepsy & Neurology, PLLC (CEN)
๐บ๐ธBoise, Idaho, United States
Northwestern Medical Group, Department of Neurology
๐บ๐ธChicago, Illinois, United States
Revive Research Institute, Inc.
๐บ๐ธRochester Hills, Michigan, United States
Bluegrass Epilepsy Research
๐บ๐ธLexington, Kentucky, United States
OLOLRMC
๐บ๐ธBaton Rouge, Louisiana, United States
University Medical Center New Orleans
๐บ๐ธNew Orleans, Louisiana, United States
Boston Clinical Trials
๐บ๐ธBoston, Massachusetts, United States
Somnos Clinical Research
๐บ๐ธLincoln, Nebraska, United States
NEREG
๐บ๐ธHackensack, New Jersey, United States
Institute of Neurology and Neurosurgery
๐บ๐ธLivingston, New Jersey, United States
Dent Neurosciences Research Center
๐บ๐ธAmherst, New York, United States
Montefiore Medical Center
๐บ๐ธBronx, New York, United States
Boston Children's Health Physicians (BCHP)
๐บ๐ธHawthorne, New York, United States
Northwell Health Pediatric Neurology
๐บ๐ธNew Hyde Park, New York, United States
NYU Langone Health
๐บ๐ธNew York, New York, United States
OnSite Clinical Solutions
๐บ๐ธCharlotte, North Carolina, United States
UPMC
๐บ๐ธPittsburgh, Pennsylvania, United States
WR-ClinSearch
๐บ๐ธChattanooga, Tennessee, United States
Vanderbilt University Medical Center
๐บ๐ธNashville, Tennessee, United States
Clinical Research Solution LLC
๐บ๐ธCypress, Texas, United States
Neurology Consultants of Dallas, PA
๐บ๐ธDallas, Texas, United States
ANESC Research
๐บ๐ธEl Paso, Texas, United States
Road Runner Research, Ltd
๐บ๐ธSan Antonio, Texas, United States
Intermountain Health
๐บ๐ธMurray, Utah, United States
Henrico Doctors' Neurology Associates, LLC
๐บ๐ธRichmond, Virginia, United States
Westmead Hospital
๐ฆ๐บWestmead, New South Wales, Australia
Royal Brisbane & Women's Hospital
๐ฆ๐บHerston, Queensland, Australia
St Vincents Hospital Melbourne - PPDS
๐ฆ๐บFitzroy, Victoria, Australia
Austin Hospital
๐ฆ๐บHeidelberg, Victoria, Australia
The Alfred Hospital
๐ฆ๐บMelbourne, Victoria, Australia
Royal Melbourne Hospital
๐ฆ๐บParkville, Victoria, Australia
Christian Doppler-Klinik - Universitรคtsklinikum der PMU
๐ฆ๐นSalzburg, Austria
Medizinische Universitรคt Wien
๐ฆ๐นWien, Austria
CHU UCL Namur - Site Godinne
๐ง๐ชYvoir, Namur, Belgium
UZ Gent
๐ง๐ชGent, Oost-Vlaanderen, Belgium
Clinical Hospital Dubrava
๐ญ๐ทZagreb, Grad Zagreb, Croatia
Clinical Hospital Sveti Duh
๐ญ๐ทZagreb, Grad Zagreb, Croatia
Helsinki University Hospital
๐ซ๐ฎHelsinki, Uusimaa, Finland
CHU de Strasbourg - Hรดpital de Hautepierre
๐ซ๐ทStrasbourg, Bas-Rhin, France
CHU Dijon Bourgogne
๐ซ๐ทDijon, Cรดte-d'Or, France
CHU de Toulouse-Hรดpital Pierre-Paul Riquet-Site de Purpan
๐ซ๐ทToulouse, Haute-Garonne, France
CHRU Lille
๐ซ๐ทLille Cedex, Nord, France
Hospices Civils de Lyon - 59 Bd Pinel
๐ซ๐ทBron, Rhรดne, France
Epilepsiezentrum Kork
๐ฉ๐ชKehl, Baden-Wรผrttemberg, Germany
Universitรคtsklinikum Ulm-Oberer Eselsberg 45
๐ฉ๐ชUlm, Baden-Wรผrttemberg, Germany
Universitรคtsklinikum Erlangen
๐ฉ๐ชErlangen, Bayern, Germany
LMU Klinikum der Universitรคt Mรผnchen - Campus Groรhadern
๐ฉ๐ชMรผnchen, Bayern, Germany
Klinikum der Johann-Wolfgang Goethe-Universitat - Schleusenweg 2-16
๐ฉ๐ชFrankfurt am Main, Hessen, Germany
Krankenhaus Mara gGmbH
๐ฉ๐ชBielefeld, Nordrhein-Westfalen, Germany
Universitรคtsklinikum Bonn
๐ฉ๐ชBonn, Nordrhein-Westfalen, Germany
Kleinwachau Sรคchsisches Epilepsiezentrum Radeberg Gemeinnรผtzige Gmbh
๐ฉ๐ชRadeberg, Sachsen, Germany
Vivantes - Humboldt Klinikum
๐ฉ๐ชBerlin, Germany
Epilepsie-Zentrum Bodensee
๐ฉ๐ชRavensburg, Germany
Ospedale Policlinico SS Annunziata - Chieti
๐ฎ๐นChieti, Abruzzo, Italy
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
๐ฎ๐นCatanzaro, Calabria, Italy
AORN Antonio Cardarelli
๐ฎ๐นNapoli, Campania, Italy
AUSL di Bologna - Ospedale Bellaria
๐ฎ๐นBologna, Emilia-Romagna, Italy
IRCCS Istituto Neurologico Mediterraneo Neuromed
๐ฎ๐นPozzilli, Isernia, Italy
Fondazione PTV Policlinico Tor Vergata
๐ฎ๐นRoma, Lazio, Italy
IRCCS Ospedale Pediatrico Bambino Gesรน - INCIPIT - PIN
๐ฎ๐นRoma, Lazio, Italy
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
๐ฎ๐นGenova, Liguria, Italy
Ospedale San Raffaele S.r.l. - PPDS
๐ฎ๐นMilano, Lombardia, Italy
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
๐ฎ๐นMilano, Lombardia, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
๐ฎ๐นPavia, Lombardia, Italy
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
๐ฎ๐นRoma, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
๐ฎ๐นVerona, Italy
Kempenhaeghe - PPDS
๐ณ๐ฑHeeze, Noord-Brabant, Netherlands
Twoja Przychodnia-Centrum Medyczne Nowa Sol
๐ต๐ฑNowa Sol, Lubuskie, Poland
Pratia MCM Krakรw
๐ต๐ฑKrakรณw, Malopolskie, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
๐ต๐ฑGdaลsk, Pomorskie, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
๐ต๐ฑPoznaล, Wielkopolskie, Poland
Neurosphera SP. Z O.O Warsaw
๐ต๐ฑWarszawa, Poland
ULS de Entre Douro e Vouga, EPE - Hospital de Sรฃo Sebastiรฃo
๐ต๐นSanta Maria Da Feira, Aveiro, Portugal
ULS de Matosinhos, EPE - Hospital Pedro Hispano
๐ต๐นSenhora Da Hora, Porto, Portugal
Centro Clรญnico Acadรฉmico, Braga - Hospital de Braga
๐ต๐นBraga, Portugal
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
๐ต๐นCoimbra, Portugal
Hospital da Luz Torres de Lisboa
๐ต๐นLisboa, Portugal
Hospital Universitario Germans Trias i Pujol
๐ช๐ธBadalona, Barcelona, Spain
Hospital Universitario de Bellvitge
๐ช๐ธL'Hospitalet De Llobregat, Barcelona, Spain
CHUVI - H.U. Alvaro Cunqueiro
๐ช๐ธVigo, Pontevedra, Spain
Hospital del Mar
๐ช๐ธBarcelona, Spain
Hospital Regional Universitario de Malaga - Hospital General
๐ช๐ธMรกlaga, Spain
Centro de Neurologia Avanzada
๐ช๐ธSevilla, Spain
Hospital Clinico Universitario de Valladolid
๐ช๐ธValladolid, Spain