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)
Hôpital Pontchaillou
🇫🇷Rennes, France
Accel Research
🇺🇸Birmingham, Alabama, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
ARENSIA Exploratory Medicine
🇺🇸Phoenix, Arizona, United States
Center for Neurosciences
🇺🇸Tucson, Arizona, United States
WRN
🇺🇸Rogers, Arkansas, United States
Amicis Research Center
🇺🇸Lancaster, California, United States
Profound Research LLC
🇺🇸Pasadena, California, United States
Medstar Health Research Institute
🇺🇸Washington, District of Columbia, United States
Nova Clinical Research, LLC
🇺🇸Bradenton, Florida, United States
University of Florida (Jacksonville)
🇺🇸Jacksonville, Florida, United States
Santa Familia PTG Lodz
🇵🇱Lódz, Lódzkie, Poland
Y&L Advance Health Care,Inc d/b/a Elite Clinical Research
🇺🇸Miami, Florida, United States
Serenity Research Center
🇺🇸Miami, Florida, United States
Floridian Research Institute
🇺🇸Miami, Florida, United States
Research Institute of Orlando
🇺🇸Orlando, Florida, United States
Comprehensive Neurology Clinic
🇺🇸Orlando, Florida, United States
Knight Neurology
🇺🇸Rockledge, Florida, United States
Santos Research Center
🇺🇸Tampa, Florida, United States
Encore Medical Research of Weston LLC.
🇺🇸Weston, Florida, United States
Hawaii Pacific Neuroscience
🇺🇸Honolulu, Hawaii, United States
Consultants in Epilepsy & Neurology, PLLC (CEN)
🇺🇸Boise, Idaho, United States
Northwestern Medical Group, Department of Neurology
🇺🇸Chicago, Illinois, United States
Revive Research Institute, Inc.
🇺🇸Rochester Hills, Michigan, United States
Bluegrass Epilepsy Research
🇺🇸Lexington, Kentucky, United States
OLOLRMC
🇺🇸Baton Rouge, Louisiana, United States
University Medical Center New Orleans
🇺🇸New Orleans, Louisiana, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Somnos Clinical Research
🇺🇸Lincoln, Nebraska, United States
NEREG
🇺🇸Hackensack, New Jersey, United States
Institute of Neurology and Neurosurgery
🇺🇸Livingston, New Jersey, United States
Dent Neurosciences Research Center
🇺🇸Amherst, New York, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Boston Children's Health Physicians (BCHP)
🇺🇸Hawthorne, New York, United States
Northwell Health Pediatric Neurology
🇺🇸New Hyde Park, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
OnSite Clinical Solutions
🇺🇸Charlotte, North Carolina, United States
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
WR-ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Clinical Research Solution LLC
🇺🇸Cypress, Texas, United States
Neurology Consultants of Dallas, PA
🇺🇸Dallas, Texas, United States
ANESC Research
🇺🇸El Paso, Texas, United States
Road Runner Research, Ltd
🇺🇸San Antonio, Texas, United States
Intermountain Health
🇺🇸Murray, Utah, United States
Henrico Doctors' Neurology Associates, LLC
🇺🇸Richmond, Virginia, United States
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Royal Brisbane & Women's Hospital
🇦🇺Herston, Queensland, Australia
St Vincents Hospital Melbourne - PPDS
🇦🇺Fitzroy, Victoria, Australia
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Christian Doppler-Klinik - Universitätsklinikum der PMU
🇦🇹Salzburg, Austria
Medizinische Universität Wien
🇦🇹Wien, Austria
CHU UCL Namur - Site Godinne
🇧🇪Yvoir, Namur, Belgium
UZ Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
Clinical Hospital Dubrava
ðŸ‡ðŸ‡·Zagreb, Grad Zagreb, Croatia
Clinical Hospital Sveti Duh
ðŸ‡ðŸ‡·Zagreb, Grad Zagreb, Croatia
Helsinki University Hospital
🇫🇮Helsinki, Uusimaa, Finland
CHU de Strasbourg - Hôpital de Hautepierre
🇫🇷Strasbourg, Bas-Rhin, France
CHU Dijon Bourgogne
🇫🇷Dijon, Côte-d'Or, France
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
🇫🇷Toulouse, Haute-Garonne, France
CHRU Lille
🇫🇷Lille Cedex, Nord, France
Hospices Civils de Lyon - 59 Bd Pinel
🇫🇷Bron, Rhône, France
Epilepsiezentrum Kork
🇩🇪Kehl, Baden-Württemberg, Germany
Universitätsklinikum Ulm-Oberer Eselsberg 45
🇩🇪Ulm, Baden-Württemberg, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Bayern, Germany
LMU Klinikum der Universität München - Campus Großhadern
🇩🇪München, Bayern, Germany
Klinikum der Johann-Wolfgang Goethe-Universitat - Schleusenweg 2-16
🇩🇪Frankfurt am Main, Hessen, Germany
Krankenhaus Mara gGmbH
🇩🇪Bielefeld, Nordrhein-Westfalen, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
🇩🇪Radeberg, Sachsen, Germany
Vivantes - Humboldt Klinikum
🇩🇪Berlin, Germany
Epilepsie-Zentrum Bodensee
🇩🇪Ravensburg, Germany
Ospedale Policlinico SS Annunziata - Chieti
🇮🇹Chieti, Abruzzo, Italy
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
🇮🇹Catanzaro, Calabria, Italy
AORN Antonio Cardarelli
🇮🇹Napoli, Campania, Italy
AUSL di Bologna - Ospedale Bellaria
🇮🇹Bologna, Emilia-Romagna, Italy
IRCCS Istituto Neurologico Mediterraneo Neuromed
🇮🇹Pozzilli, Isernia, Italy
Fondazione PTV Policlinico Tor Vergata
🇮🇹Roma, Lazio, Italy
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
🇮🇹Roma, Lazio, Italy
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
🇮🇹Genova, Liguria, Italy
Ospedale San Raffaele S.r.l. - PPDS
🇮🇹Milano, Lombardia, Italy
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
🇮🇹Milano, Lombardia, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
🇮🇹Pavia, Lombardia, Italy
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
🇮🇹Roma, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
🇮🇹Verona, Italy
Kempenhaeghe - PPDS
🇳🇱Heeze, Noord-Brabant, Netherlands
Twoja Przychodnia-Centrum Medyczne Nowa Sol
🇵🇱Nowa Sol, Lubuskie, Poland
Pratia MCM KrakÛw
🇵🇱Kraków, Malopolskie, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
🇵🇱Gdańsk, Pomorskie, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
🇵🇱Poznań, Wielkopolskie, Poland
Neurosphera SP. Z O.O Warsaw
🇵🇱Warszawa, Poland
ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
🇵🇹Santa Maria Da Feira, Aveiro, Portugal
ULS de Matosinhos, EPE - Hospital Pedro Hispano
🇵🇹Senhora Da Hora, Porto, Portugal
Centro ClÃnico Académico, Braga - Hospital de Braga
🇵🇹Braga, Portugal
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
🇵🇹Coimbra, Portugal
Hospital da Luz Torres de Lisboa
🇵🇹Lisboa, Portugal
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario de Bellvitge
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
CHUVI - H.U. Alvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Regional Universitario de Malaga - Hospital General
🇪🇸Málaga, Spain
Centro de Neurologia Avanzada
🇪🇸Sevilla, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain