Phase
Condition
Epilepsy
Epilepsy (Pediatric)
Seizure Disorders
Treatment
BHV-7000
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 thescreening 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 seizuresand either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-waveon 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 andeither Normal EEG OR Generalized epileptiform EEG abnormality with atypicalspike-wave and no focal abnormality (asymmetric spike-wave fragment isallowed).
Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure ofadequate 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 epilepsytreatments in total (e.g., each ASM is considered 1 treatment. Other epilepsytherapies including devices and diet therapy are allowed; together these othertherapies count as 1 treatment).
Accurate history of having at least 3 days with a GTC seizure evenly spreadthroughout the 16 weeks prior to the screening visit, such that a subject had atleast 1 day with a GTC seizure during the first 8 weeks and at least 1 day with aGTC seizure during the second 8 weeks.
Exclusion
Exclusion Criteria:
History of status epilepticus (convulsive status epilepticus for > 5 minutes orfocal status epilepticus with impaired conscious for > 10 minutes) within the last 6months prior to screening visit that is not consistent with the subject's habitualseizure.
History of repetitive/cluster GTC seizures (where individual seizures cannot becounted) within the last 6 months prior to screening visit, or havingrepetitive/cluster GTC seizures count during the screening phase.
Any condition that would interfere with and/or confound the interpretation of safetyor efficacy data from the study, as judged by the Investigator
Study Design
Connect with a study center
Westmead Hospital
Westmead, New South Wales 2145
AustraliaActive - Recruiting
Royal Brisbane & Women's Hospital
Herston, Queensland 4029
AustraliaSite Not Available
St Vincents Hospital Melbourne - PPDS
Fitzroy, Victoria 3065
AustraliaSite Not Available
Austin Hospital
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Royal Melbourne Hospital
Parkville, Victoria 3050
AustraliaActive - Recruiting
Christian Doppler-Klinik - Universitätsklinikum der PMU
Salzburg, A-5020
AustriaActive - Recruiting
Medizinische Universität Wien
Wien, 1090
AustriaActive - Recruiting
UZ Gent
Gent, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
Clinical Hospital Dubrava
Zagreb, Grad Zagreb 10000
CroatiaSite Not Available
Clinical Hospital Sveti Duh
Zagreb, Grad Zagreb 10000
CroatiaActive - Recruiting
Helsinki University Hospital
Helsinki, Uusimaa 00290
FinlandActive - Recruiting
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, Bas-Rhin 67000
FranceActive - Recruiting
CHU Dijon Bourgogne
Dijon, Côte-d'Or 21000
FranceActive - Recruiting
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
Toulouse, Haute-Garonne 31059
FranceActive - Recruiting
CHRU Lille
Lille Cedex, Nord 59037
FranceActive - Recruiting
Hospices Civils de Lyon - 59 Bd Pinel
Bron, Rhône 69677
FranceActive - Recruiting
Hôpital Pontchaillou
Rennes, 35033
FranceActive - Recruiting
Epilepsiezentrum Kork
Kehl, Baden-Württemberg 77694
GermanyActive - Recruiting
Universitätsklinikum Ulm-Oberer Eselsberg 45
Ulm, Baden-Württemberg 89081
GermanyActive - Recruiting
Universitätsklinikum Erlangen
Erlangen, Bayern 91054
GermanyActive - Recruiting
LMU Klinikum der Universität München - Campus Großhadern
München, Bayern 81377
GermanyActive - Recruiting
Klinikum der Johann-Wolfgang Goethe-Universitat - Schleusenweg 2-16
Frankfurt am Main, Hessen 60528
GermanyActive - Recruiting
Krankenhaus Mara gGmbH
Bielefeld, Nordrhein-Westfalen 33617
GermanyActive - Recruiting
Universitätsklinikum Bonn
Bonn, Nordrhein-Westfalen 53127
GermanyActive - Recruiting
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
Radeberg, Sachsen 01454
GermanyActive - Recruiting
Vivantes - Humboldt Klinikum
Berlin, 13509
GermanyActive - Recruiting
Epilepsie-Zentrum Bodensee
Ravensburg, 88214
GermanySite Not Available
Ospedale Policlinico SS Annunziata - Chieti
Chieti, Abruzzo 66013
ItalySite Not Available
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
Catanzaro, Calabria 88100
ItalyActive - Recruiting
AORN Antonio Cardarelli
Napoli, Campania 80131
ItalyActive - Recruiting
AUSL di Bologna - Ospedale Bellaria
Bologna, Emilia-Romagna 40139
ItalyActive - Recruiting
IRCCS Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Isernia 86077
ItalyActive - Recruiting
Fondazione PTV Policlinico Tor Vergata
Roma, Lazio 00133
ItalyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Roma, Lazio 165
ItalyActive - Recruiting
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genova, Liguria 16147
ItalyActive - Recruiting
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
Milano, Lombardia 20142
ItalyActive - Recruiting
Ospedale San Raffaele S.r.l. - PPDS
Milano, Lombardia 20132
ItalyActive - Recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Lombardia 27100
ItalyActive - Recruiting
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Roma, 168
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, 37126
ItalyActive - Recruiting
Kempenhaeghe - PPDS
Heeze, Noord-Brabant 5591 VE
NetherlandsActive - Recruiting
Twoja Przychodnia-Centrum Medyczne Nowa Sol
Nowa Sol, Lubuskie 67-100
PolandActive - Recruiting
Santa Familia PTG Lodz
Lódz, Lódzkie 90-302
PolandActive - Recruiting
Pratia MCM KrakÛw
Kraków, Malopolskie 30-727
PolandActive - Recruiting
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Kraków, Malopolskie 30-727
PolandActive - Recruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdańsk, Pomorskie 80-546
PolandActive - Recruiting
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznań, Wielkopolskie 60-702
PolandActive - Recruiting
Neurosphera SP. Z O.O Warsaw
Warszawa, 02-829
PolandSite Not Available
ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
Santa Maria Da Feira, Aveiro 4520-211
PortugalActive - Recruiting
ULS de Matosinhos, EPE - Hospital Pedro Hispano
Senhora Da Hora, Porto 4464-513
PortugalActive - Recruiting
Centro Clínico Académico, Braga - Hospital de Braga
Braga, 4710-243
PortugalActive - Recruiting
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, 3000-075
PortugalActive - Recruiting
Hospital da Luz Torres de Lisboa
Lisboa, 1600-209
PortugalActive - Recruiting
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona 8916
SpainActive - Recruiting
Hospital Universitario de Bellvitge
L'Hospitalet De Llobregat, Barcelona 08907
SpainActive - Recruiting
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra 36312
SpainActive - Recruiting
Hospital del Mar
Barcelona, 08003
SpainActive - Recruiting
Hospital Regional Universitario de Malaga - Hospital General
Málaga, 29010
SpainActive - Recruiting
Centro de Neurologia Avanzada
Sevilla, 41013
SpainActive - Recruiting
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
SpainActive - Recruiting
Accel Research
Birmingham, Alabama 35244
United StatesActive - Recruiting
ARENSIA Exploratory Medicine
Phoenix, Arizona 85015
United StatesActive - Recruiting
Barrow Neurological Institute
Phoenix, Arizona 85013
United StatesActive - Recruiting
Center for Neurosciences
Tucson, Arizona 85718
United StatesActive - Recruiting
WRN
Rogers, Arkansas 72758
United StatesSite Not Available
Amicis Research Center
Lancaster, California 93534
United StatesSite Not Available
Profound Research LLC
Pasadena, California 91105
United StatesActive - Recruiting
Medstar Health Research Institute
Washington, District of Columbia 20010
United StatesActive - Recruiting
Nova Clinical Research, LLC
Bradenton, Florida 34209
United StatesActive - Recruiting
University of Florida (Jacksonville)
Jacksonville, Florida 32209
United StatesActive - Recruiting
Floridian Research Institute
Miami, Florida 33179
United StatesActive - Recruiting
Serenity Research Center
Miami, Florida 33176
United StatesActive - Recruiting
Y&L Advance Health Care,Inc d/b/a Elite Clinical Research
Miami, Florida 33144
United StatesActive - Recruiting
Comprehensive Neurology Clinic
Orlando, Florida 32825
United StatesSite Not Available
Research Institute of Orlando
Orlando, Florida 32806
United StatesActive - Recruiting
Knight Neurology
Rockledge, Florida 32955
United StatesActive - Recruiting
Santos Research Center
Tampa, Florida 33615
United StatesActive - Recruiting
Encore Medical Research of Weston LLC.
Weston, Florida 33331
United StatesActive - Recruiting
Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817
United StatesActive - Recruiting
Consultants in Epilepsy & Neurology, PLLC (CEN)
Boise, Idaho 83702
United StatesActive - Recruiting
Northwestern
Chicago, Illinois 60611
United StatesActive - Recruiting
Northwestern Medical Group, Department of Neurology
Chicago, Illinois 60611
United StatesActive - Recruiting
Revive Research Institute, Inc.
Elgin, Illinois 60123
United StatesSite Not Available
Bluegrass Epilepsy Research
Lexington, Kentucky 40504
United StatesActive - Recruiting
OLOLRMC
Baton Rouge, Louisiana 70808
United StatesSite Not Available
University Medical Center New Orleans
New Orleans, Louisiana 70112
United StatesActive - Recruiting
Boston Clinical Trials
Boston, Massachusetts 02131
United StatesActive - Recruiting
Revive Research Institute, Inc.
Rochester Hills, Michigan 48307
United StatesSite Not Available
Somnos Clinical Research
Lincoln, Nebraska 68510
United StatesActive - Recruiting
NEREG
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Inst of Neurology
Livingston, New Jersey 07039
United StatesActive - Recruiting
Institute of Neurology and Neurosurgery
Livingston, New Jersey 07039
United StatesActive - Recruiting
Dent Neurosciences Research Center
Amherst, New York 14226
United StatesActive - Recruiting
Montefiore Medical Center
Bronx, New York 10467
United StatesActive - Recruiting
Northwell Health Pediatric Neurology
New Hyde Park, New York 11042
United StatesSite Not Available
NYU Langone Health
New York, New York 10016
United StatesSite Not Available
OnSite Clinical Solutions
Charlotte, North Carolina 28211
United StatesSite Not Available
UPMC
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
WR-ClinSearch
Chattanooga, Tennessee 37421
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesActive - Recruiting
Clinical Research Solution LLC
Cypress, Texas 77429
United StatesSite Not Available
Neurology Consultants of Dallas, PA
Dallas, Texas 75243
United StatesActive - Recruiting
ANESC Research
El Paso, Texas 79912
United StatesActive - Recruiting
UTHealth Houston
Houston, Texas 77030
United StatesSite Not Available
Road Runner Research, Ltd
San Antonio, Texas 78249
United StatesActive - Recruiting
Intermountain Health
Murray, Utah 84107
United StatesSite Not Available
Henrico Doctors' Neurology Associates, LLC
Richmond, Virginia 23235
United StatesActive - Recruiting
Henrico Doctors'Neurology Associates, LLC
Richmond, Virginia 23235
United StatesActive - Recruiting
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