Clinical trial NCT06425159: A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Generalized Epilepsy
Keywords: Idiopathic Generalized Epilepsy
Generalized
Epilepsy
tonic-clonic
generalized tonic-clonic
tonic
clonic
seizure
refractory epilepsy
generalized tonic-clonic alone
juvenile myoclonic epilepsy
juvenile absence epilepsy
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-22
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period
timeFrame: Baseline to Week 24 of Double-Blind Treatment Period
Secondary outcomes:
measure: Percentage of Participants with freedom of GTC seizures during DBT Phase
timeFrame: Baseline to Week 24 of Double-Blind Treatment Period
measure: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
timeFrame: Baseline to Week 24 of Double-Blind Treatment Period
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Baseline to Week 24 of Double-Blind Treatment Period
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Phoenix
country: United States
facility: ARENSIA Exploratory Medicine
state: Arizona
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Rogers
country: United States
facility: WRN
state: Arkansas
city: Lancaster
country: United States
facility: Amicis Research Center
state: California
city: Pasadena
country: United States
facility: Profound Research LLC
state: California
city: Washington
country: United States
facility: Medstar Health Research Institute
state: District of Columbia
city: Bradenton
country: United States
facility: Nova Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: University of Florida (Jacksonville)
state: Florida
city: Miami
country: United States
facility: Y&L Advance Health Care,Inc d/b/a Elite Clinical Research
state: Florida
city: Miami
country: United States
facility: Serenity Research Center
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute
state: Florida
city: Orlando
country: United States
facility: Research Institute of Orlando
state: Florida
city: Orlando
country: United States
facility: Comprehensive Neurology Clinic
state: Florida
city: Rockledge
country: United States
facility: Knight Neurology
state: Florida
city: Tampa
country: United States
facility: Santos Research Center
state: Florida
city: Weston
country: United States
facility: Encore Medical Research of Weston LLC.
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience
state: Hawaii
city: Boise
country: United States
facility: Consultants in Epilepsy & Neurology, PLLC (CEN)
state: Idaho
city: Chicago
country: United States
facility: Northwestern Medical Group, Department of Neurology
state: Illinois
city: Elgin
country: United States
facility: Revive Research Institute, Inc.
state: Illinois
city: Lexington
country: United States
facility: Bluegrass Epilepsy Research
state: Kentucky
city: Baton Rouge
country: United States
facility: OLOLRMC
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Rochester Hills
country: United States
facility: Revive Research Institute, Inc.
state: Michigan
city: Lincoln
country: United States
facility: Somnos Clinical Research
state: Nebraska
city: Hackensack
country: United States
facility: NEREG
state: New Jersey
city: Livingston
country: United States
facility: Institute of Neurology and Neurosurgery
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Hawthorne
country: United States
facility: Boston Children's Health Physicians (BCHP)
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health Pediatric Neurology
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions
state: North Carolina
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Chattanooga
country: United States
facility: WR-ClinSearch
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Cypress
country: United States
facility: Clinical Research Solution LLC
state: Texas
city: Dallas
country: United States
facility: Neurology Consultants of Dallas, PA
state: Texas
city: El Paso
country: United States
facility: ANESC Research
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, Ltd
state: Texas
city: Murray
country: United States
facility: Intermountain Health
state: Utah
city: Richmond
country: United States
facility: Henrico Doctors' Neurology Associates, LLC
state: Virginia
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne - PPDS
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Salzburg
country: Austria
facility: Christian Doppler-Klinik - Universitätsklinikum der PMU
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Yvoir
country: Belgium
facility: CHU UCL Namur - Site Godinne
state: Namur
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Clinical Hospital Sveti Duh
state: Grad Zagreb
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
city: Strasbourg
country: France
facility: CHU de Strasbourg - Hôpital de Hautepierre
state: Bas-Rhin
city: Dijon
country: France
facility: CHU Dijon Bourgogne
state: Côte-d'Or
city: Toulouse
country: France
facility: CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
state: Haute-Garonne
city: Lille Cedex
country: France
facility: CHRU Lille
state: Nord
city: Bron
country: France
facility: Hospices Civils de Lyon - 59 Bd Pinel
state: Rhône
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Kehl
country: Germany
facility: Epilepsiezentrum Kork
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm-Oberer Eselsberg 45
state: Baden-Württemberg
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: München
country: Germany
facility: LMU Klinikum der Universität München - Campus Großhadern
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann-Wolfgang Goethe-Universitat - Schleusenweg 2-16
state: Hessen
city: Bielefeld
country: Germany
facility: Krankenhaus Mara gGmbH
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: Nordrhein-Westfalen
city: Radeberg
country: Germany
facility: Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
state: Sachsen
city: Berlin
country: Germany
facility: Vivantes - Humboldt Klinikum
city: Ravensburg
country: Germany
facility: Epilepsie-Zentrum Bodensee
city: Chieti
country: Italy
facility: Ospedale Policlinico SS Annunziata - Chieti
state: Abruzzo
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
state: Calabria
city: Napoli
country: Italy
facility: AORN Antonio Cardarelli
state: Campania
city: Bologna
country: Italy
facility: AUSL di Bologna - Ospedale Bellaria
state: Emilia-Romagna
city: Pozzilli
country: Italy
facility: IRCCS Istituto Neurologico Mediterraneo Neuromed
state: Isernia
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
state: Lazio
city: Roma
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
state: Lazio
city: Genova
country: Italy
facility: Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
state: Liguria
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l. - PPDS
state: Lombardia
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
state: Lombardia
city: Baggiovara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
state: Modena
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Di Verona
city: Heeze
country: Netherlands
facility: Kempenhaeghe - PPDS
state: Noord-Brabant
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia-Centrum Medyczne Nowa Sol
state: Lubuskie
city: Lódz
country: Poland
facility: Santa Familia PTG Lodz
state: Lódzkie
city: Kraków
country: Poland
facility: Pratia MCM KrakÛw
state: Malopolskie
city: Gdańsk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Poznań
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
state: Wielkopolskie
city: Warszawa
country: Poland
facility: Neurosphera SP. Z O.O Warsaw
city: Santa Maria Da Feira
country: Portugal
facility: ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
state: Aveiro
city: Senhora Da Hora
country: Portugal
facility: ULS de Matosinhos, EPE - Hospital Pedro Hispano
state: Porto
city: Braga
country: Portugal
facility: Centro Clínico Académico, Braga - Hospital de Braga
city: Coimbra
country: Portugal
facility: ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
city: Lisboa
country: Portugal
facility: Hospital da Luz Torres de Lisboa
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Vigo
country: Spain
facility: CHUVI - H.U. Alvaro Cunqueiro
state: Pontevedra
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga - Hospital General
city: Sevilla
country: Spain
facility: Centro de Neurologia Avanzada
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
Study officials:
References: