A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Start Date
3/14/2024
Completion Date
12/1/2026
Summary
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Detailed Description
This study has two parts, Part A and Part B. Part A is randomized 1:1:1 25 mg of BHV-7000, 50 mg of BHV-7000 or matching placebo. Part B is randomized 1:1 75mg BHV-7000 or matching placebo. Part B will start after Part A.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
BHV-7000
BHV-7000
Placebo
BHV-7000
Placebo
Conditions
Locations
Barrow Neurological Institute
Phoenix, Arizona 85013
United States
Center for Neurosciences
Tucson, Arizona 85718
United States
Clinical Trials, Inc.
Little Rock, Arkansas 72205
United States
WRN
Rogers, Arkansas 72758
United States
University of California San Diego
La Jolla, California 92041
United States
University of California, Los Angeles
Los Angeles, California 90095
United States
Stanford Health Care
Palo Alto, California 94304
United States
Profound Research LLC
Pasadena, California 91105
United States
University of Colorado Anschultz Medical Campus
Aurora, Colorado 80045
United States
Yale School of Medicine - Yale-New Haven Hospital
New Haven, Connecticut 06519
United States
EZR Research LLC
Boca Raton, Florida 33486
United States
Nova Clinical Research, LLC
Bradenton, Florida 34209
United States
University of Florida (Jacksonville)
Jacksonville, Florida 32209
United States
University of Miami
Miami, Florida 33136
United States
Floridian Research Institute
Miami, Florida 33179
United States
AdventHealth Orlando
Orlando, Florida 32804
United States
Medsol Clinical Research Center
Port Charlotte, Florida 33952
United States
Santos Research Center
Tampa, Florida 33615
United States
Encore Medical Research of Weston LLC.
Weston, Florida 33331
United States
Pediatrix Medical Group of Florida
Winter Park, Florida 32789
United States
Augusta University
Augusta, Georgia 30912
United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817
United States
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho 83702
United States
Northwestern University
Chicago, Illinois 60611
United States
Revive Research Institute, Inc.
Elgin, Illinois 60123
United States
Accellacare
Ames, Iowa 50010
United States
Bluegrass Epilepsy Research
Lexington, Kentucky 40504
United States
MAESC
Bethesda, Maryland 20817
United States
Javara
Silver Spring, Maryland 20901
United States
Revive Research Institute, Inc.
Rochester Hills, Michigan 48307
United States
Minnesota Epilepsy Group, P.A.
Roseville, Minnesota 55113
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
NEREG
Hackensack, New Jersey 07601
United States
Inst of Neurology
Livingston, New Jersey 07039
United States
Dent Neurosciences Research Center
Amherst, New York 14226
United States
BCHP
Hawthorne, New York 10532
United States
Northwell Health
New York, New York 10021
United States
Icahn School of Medicine at Mt. Sinai
New York, New York 10029
United States
Stony Brook Medicine
Stony Brook, New York 11794
United States
Five Towns Neuroscience Research
Woodmere, New York 11598
United States
OnSite Clinical Solutions
Charlotte, North Carolina 28211
United States
Accellacare
Mooresville, North Carolina 28117
United States
Wake Forest Baptist
Winston-Salem, North Carolina 27157
United States
NeuroScience Research Center
Canton, Ohio 44718
United States
University of Cincinnati
Cincinnati, Ohio 45267
United States
OSU
Columbus, Ohio 43214
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
UPMC
Pittsburgh, Pennsylvania 15213
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Clinical Research Solutions LLC
Cypress, Texas 77433
United States
Neurology Consultants of Dallas, PA
Dallas, Texas 75243
United States
Tarrant Neurology Consultants
Fort Worth, Texas 76104
United States
Michael E. DeBakey VA Medical Center
Houston, Texas 77030
United States
UT Health San Antonio
San Antonio, Texas 78229
United States
Road Runner Research, Ltd
San Antonio, Texas 78249
United States
University of Utah
Salt Lake City, Utah 84132
United States
UVM MC
Burlington, Vermont 05401
United States
University of Virginia
Charlottesville, Virginia 22903
United States
Henrico Doctors Neurology Associates, LLC
Richmond, Virginia 23235
United States
Carilion Clinic
Roanoke, Virginia 24011
United States
STAT Research S.A.
Ciudad Autónoma de Buenos Aires, Buenos Aires C1013AAB
Argentina
Hospital General de Agudos Dr. José María Ramos Mejia
Balvanera, Ciudad Autónoma de BuenosAires C1221ADC
Argentina
Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102
Buenos Aires, Ciudad Autónoma de BuenosAires C1431FWO
Argentina
Hospital Británico de Buenos Aires
Buenos Aires, Ciudad Autónoma de BuenosAires C1437JCH
Argentina
Investigaciones Sanatorio Del Sur
San Miguel de Tucumán, Tucumán Province T4000AXL
Argentina
Sanatorio de la Trinidad - Mitre
Buenos Aires, C1039AAO
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH
Argentina
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
Buenos Aires, C1428AQK
Argentina
Instituto Privado Kremer
Córdoba, X5004AOA
Argentina
Conci Carpinella - Santa Rosa N° 748
Córdoba, X5008HHW
Argentina
Kepler Universitätsklinikum Linz - Med Campus III
Linz, Upper Austria 4020
Austria
Christian Doppler-Klinik - Universitätsklinikum der PMU
Salzburg, 5020
Austria
Universitätsklinikum St. Pölten
Sankt Pölten, 3100
Austria
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, 1090
Austria
UZ Antwerpen
Edegem, Antwerpen 2650
Belgium
Hôpital Erasme
Anderlecht, Brussels Capital 1070
Belgium
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital 1200
Belgium
CHU UCL Namur - Site Godinne
Yvoir, Namur 5530
Belgium
UZ Gent
Ghent, Oost-Vlaanderen 9000
Belgium
Centro de especialidades médicas Vanguardia
Temuco, Araucania 4780000
Chile
Hospital Padre Hurtado
Santiago, Región-MetropolitanadeSantiago 8260094
Chile
BIOCINETIC Ltda
Santiago, Región-MetropolitanadeSantiago 8320000
Chile
Centro de Investigacion Clinica UC
Santiago, Región-MetropolitanadeSantiago 8320000
Chile
Instituto Neurologico Thalamus
Viña del Mar, Valparaiso 2520021
Chile
Clinical Hospital Sveti duh
Zagreb, City of Zagreb 10000
Croatia
Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29
Zagreb, City of Zagreb 10000
Croatia
Clinical Hospital Center Rijeka - PPDS
Rijeka, 51000
Croatia
Fakultni nemocnice v Motole
Prague, Praha, Hlavní Mesto 150 06
Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, South Moravian 602 00
Czechia
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, Bas-Rhin 67000
France
CHU Dijon Bourgogne
Dijon, Côte-d'Or 21000
France
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
Toulouse, Haute-Garonne 31059
France
CHU de Montpellier- Hôpital Gui De Chauliac
Montpellier, Hérault 34295
France
CHRU de Tours - Hôpital Bretonneau
Tours, Indre-et-Loire 37000
France
CHRU Nancy
Nancy, Meurthe-et-Moselle 54000
France
CHU de Lille - Hopital Claude Huriez
Lille, Nord 59037
France
Hospices Civils de Lyon - 59 Bd Pinel
Lyon, Rhône 69003
France
Hôpital Pontchaillou
Rennes, 35033
France
Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
Pécs, Baranya 7623
Hungary
Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus
Debrecen, Hajdú-Bihar 4031
Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, 1106
Hungary
SE INK Juhasz Pal Epilepszia Központ
Budapest, 1145
Hungary
Kempenhaeghe - PPDS
Heeze, North Brabant 5591 VE
Netherlands
Stichting Epilepsie Instellingen Nederland - Heemstede
Heemstede, North Holland 2103 SW
Netherlands
Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20
Zwolle, Overijssel 8025 BV
Netherlands
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship 60-702
Poland
Przychodnia VISTAMED
Wroclaw, Lower Silesian Voivodeship 53-149
Poland
Clinical Best Solutions - Lublin
Lublin, Lublin Voivodeship 20-078
Poland
NZOZ IGNIS dr med. Alicja Lobinska
Świdnik, Lublin Voivodeship 21-040
Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
Nowa Sól, Lubusz Voivodeship 67-100
Poland
Santa Familia PTG Lodz
Lodz, Lódzkie 90-302
Poland
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, Masovian Voivodeship 02-172
Poland
Neurosphera SP. Z O.O
Warsaw, Masovian Voivodeship 02-829
Poland
Instytut Psychiatrii i Neurologii
Warsaw, Masovian Voivodeship 02-957
Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship 80-546
Poland
Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6
Gdansk, 80-803
Poland
Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44
Katowice, 40-594
Poland
Pratia MCM Kraków
Krakow, 30-727
Poland
LANDA Specjalistyczne Gabinety Lekarskie
Krakow, 31-156
Poland
University Clinical Centre Maribor
Maribor, 2000
Slovenia
InnoMed Clinical Trial Centre
Cape Town, Western Cape 7530
South Africa
Groote Schuur Hospital
Cape Town, Western Cape 7700
South Africa
Klinik Lengg AG
Zurich, Zürich (de) 8008
Switzerland