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

Status: Recruiting
Location: See all (114) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Accel Research
RECRUITING
Birmingham
Arkansas
WRN
WITHDRAWN
Rogers
Arizona
ARENSIA Exploratory Medicine
RECRUITING
Phoenix
Barrow Neurological Institute
RECRUITING
Phoenix
Center for Neurosciences
RECRUITING
Tucson
California
Amicis Research Center
WITHDRAWN
Lancaster
Profound Research LLC
RECRUITING
Pasadena
Washington, D.c.
Medstar Health Research Institute
RECRUITING
Washington D.c.
Florida
Nova Clinical Research, LLC
RECRUITING
Bradenton
University of Florida (Jacksonville)
RECRUITING
Jacksonville
Floridian Research Institute
WITHDRAWN
Miami
Serenity Research Center
RECRUITING
Miami
Y&L Advance Health Care,Inc d/b/a Elite Clinical Research
RECRUITING
Miami
Comprehensive Neurology Clinic
RECRUITING
Orlando
Research Institute of Orlando
RECRUITING
Orlando
Knight Neurology
RECRUITING
Rockledge
Santos Research Center
RECRUITING
Tampa
Encore Medical Research of Weston LLC.
RECRUITING
Weston
Georgia
Augusta University
RECRUITING
Augusta
Hawaii
Hawaii Pacific Neuroscience
RECRUITING
Honolulu
Idaho
Consultants in Epilepsy & Neurology, PLLC (CEN)
RECRUITING
Boise
Illinois
Northwestern Medical Group, Department of Neurology
RECRUITING
Chicago
Revive Research Institute, Inc.
NOT_YET_RECRUITING
Elgin
Kentucky
Bluegrass Epilepsy Research
RECRUITING
Lexington
Louisiana
OLOLRMC
NOT_YET_RECRUITING
Baton Rouge
University Medical Center New Orleans
RECRUITING
New Orleans
Massachusetts
Boston Clinical Trials
RECRUITING
Boston
Michigan
Revive Research Institute, Inc.
WITHDRAWN
Rochester Hills
North Carolina
OnSite Clinical Solutions
WITHDRAWN
Charlotte
Nebraska
Somnos Clinical Research
RECRUITING
Lincoln
New Jersey
NEREG
RECRUITING
Hackensack
Institute of Neurology and Neurosurgery
RECRUITING
Livingston
New York
Dent Neurosciences Research Center
RECRUITING
Amherst
Boston Children's Health Physicians (BCHP)
RECRUITING
Hawthorne
Northwell Health Pediatric Neurology
NOT_YET_RECRUITING
New Hyde Park
NYU Langone Health
NOT_YET_RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Pennsylvania
UPMC
NOT_YET_RECRUITING
Pittsburgh
Tennessee
WR-ClinSearch
RECRUITING
Chattanooga
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Clinical Research Solution LLC
WITHDRAWN
Cypress
Neurology Consultants of Dallas, PA
RECRUITING
Dallas
ANESC Research
RECRUITING
El Paso
Road Runner Research, Ltd
RECRUITING
San Antonio
Utah
Intermountain Health
RECRUITING
Murray
Virginia
Henrico Doctors' Neurology Associates, LLC
RECRUITING
Richmond
Other Locations
Australia
St Vincents Hospital Melbourne - PPDS
RECRUITING
Fitzroy
Austin Hospital
RECRUITING
Heidelberg
Royal Brisbane & Women's Hospital
RECRUITING
Herston
The Alfred Hospital
RECRUITING
Melbourne
Royal Melbourne Hospital
RECRUITING
Parkville
Westmead Hospital
RECRUITING
Westmead
Austria
Christian Doppler-Klinik - Universitätsklinikum der PMU
RECRUITING
Salzburg
Medizinische Universität Wien
RECRUITING
Vienna
Belgium
UZ Antwerpen
RECRUITING
Edegem
UZ Gent
RECRUITING
Ghent
CHU UCL Namur - Site Godinne
RECRUITING
Yvoir
Croatia
Clinical Hospital Dubrava
NOT_YET_RECRUITING
Zagreb
Clinical Hospital Sveti Duh
RECRUITING
Zagreb
Finland
Helsinki University Hospital
RECRUITING
Helsinki
France
Hospices Civils de Lyon - 59 Bd Pinel
RECRUITING
Bron
CHU Dijon Bourgogne
RECRUITING
Dijon
CHRU Lille
RECRUITING
Lille
Hôpital Pontchaillou
RECRUITING
Rennes
CHU de Strasbourg - Hôpital de Hautepierre
RECRUITING
Strasbourg
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
RECRUITING
Toulouse
Germany
Vivantes - Humboldt Klinikum
RECRUITING
Berlin
Krankenhaus Mara gGmbH
RECRUITING
Bielefeld
Universitätsklinikum Bonn
RECRUITING
Bonn
Universitätsklinikum Erlangen
RECRUITING
Erlangen
Klinikum der Johann-Wolfgang Goethe-Universitat - Schleusenweg 2-16
RECRUITING
Frankfurt Am Main
Epilepsiezentrum Kork
RECRUITING
Kehl
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
RECRUITING
Marburg
LMU Klinikum der Universität München - Campus Großhadern
RECRUITING
München
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
RECRUITING
Radeberg
Epilepsie-Zentrum Bodensee
RECRUITING
Ravensburg
Universitätsklinikum Ulm-Oberer Eselsberg 45
RECRUITING
Ulm
Italy
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
RECRUITING
Baggiovara
AUSL di Bologna - Ospedale Bellaria
RECRUITING
Bologna
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
RECRUITING
Catanzaro
Ospedale Policlinico SS Annunziata - Chieti
RECRUITING
Chieti
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
RECRUITING
Genoa
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
RECRUITING
Milan
Ospedale San Raffaele S.r.l. - PPDS
RECRUITING
Milan
AORN Antonio Cardarelli
RECRUITING
Napoli
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
RECRUITING
Pavia
IRCCS Istituto Neurologico Mediterraneo Neuromed
RECRUITING
Pozzilli
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
RECRUITING
Roma
Fondazione PTV Policlinico Tor Vergata
RECRUITING
Rome
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
RECRUITING
Rome
Azienda Ospedaliera Universitaria Integrata Di Verona
RECRUITING
Verona
Netherlands
Kempenhaeghe - PPDS
RECRUITING
Heeze
Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
RECRUITING
Gdansk
Pratia MCM KrakÛw
RECRUITING
Krakow
Santa Familia PTG Lodz
RECRUITING
Lódz
Twoja Przychodnia-Centrum Medyczne Nowa Sol
RECRUITING
Nowa Sól
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
RECRUITING
Poznan
Neurosphera SP. Z O.O Warsaw
NOT_YET_RECRUITING
Warsaw
Portugal
Centro Clínico Académico, Braga - Hospital de Braga
RECRUITING
Braga
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
RECRUITING
Coimbra
Hospital da Luz Torres de Lisboa
RECRUITING
Lisbon
ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
RECRUITING
Santa Maria Da Feira
ULS de Matosinhos, EPE - Hospital Pedro Hispano
RECRUITING
Senhora Da Hora
Spain
Hospital Universitario Germans Trias i Pujol
RECRUITING
Badalona
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital Regional Universitario de Malaga - Hospital General
RECRUITING
Málaga
Centro de Neurologia Avanzada
RECRUITING
Seville
Hospital Clinico Universitario de Valladolid
RECRUITING
Valladolid
CHUVI - H.U. Alvaro Cunqueiro
RECRUITING
Vigo
United Kingdom
Neuroscience Research Centre
NOT_YET_RECRUITING
Fazakerley
Morriston Hospital
NOT_YET_RECRUITING
Morriston
The Royal Victoria Infirmary
NOT_YET_RECRUITING
Newcastle Upon Tyne
Salford Royal Hospital
NOT_YET_RECRUITING
Salford
Contact Information
Primary
Chief Medical Officer
clinicaltrials@biohavenpharma.com
203-404-0410
Time Frame
Start Date: 2024-06-20
Estimated Completion Date: 2027-07
Participants
Target number of participants: 242
Treatments
Active_comparator: BHV-7000 75 mg
Placebo_comparator: Placebo
Sponsors
Leads: Biohaven Therapeutics Ltd.

This content was sourced from clinicaltrials.gov