- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT06132893
Een onderzoek om te bepalen of BHV-7000 effectief en veilig is bij volwassenen met refractaire focale epilepsie (RISE 2)
Een fase 2/3 multicenter, gerandomiseerde, dubbelblinde, placebogecontroleerde studie om de werkzaamheid, veiligheid en verdraagbaarheid van BHV-7000 te evalueren bij proefpersonen met refractaire focale epilepsie
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
- Fase 3
Contacten en locaties
Studie Locaties
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Buenos Aires, Argentinië, C1181ACH
- Hospital Italiano de Buenos Aires
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Buenos Aires, Argentinië, C1428AQK
- Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
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Buenos Aires, Argentinië, C1039AAO
- Sanatorio de la Trinidad - Mitre
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Córdoba, Argentinië, X5004AOA
- Instituto Privado Kremer
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Córdoba, Argentinië, X5008HHW
- Conci Carpinella - Santa Rosa N° 748
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Buenos Aires
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentinië, C1013AAB
- STAT Research S.A.
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Ciudad Autónoma de BuenosAires
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Balvanera, Ciudad Autónoma de BuenosAires, Argentinië, C1221ADC
- Hospital General de Agudos Dr. José María Ramos Mejia
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Buenos Aires, Ciudad Autónoma de BuenosAires, Argentinië, C1437JCH
- Hospital Británico de Buenos Aires
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentinië, T4000AXL
- Investigaciones Sanatorio Del Sur
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Antwerpen
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Edegem, Antwerpen, België, 2650
- UZ Antwerpen
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Brussels Capital
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Anderlecht, Brussels Capital, België, 1070
- Hôpital Erasme
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Brussels, Brussels Capital, België, 1200
- Cliniques Universitaires Saint-Luc
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Namur
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Yvoir, Namur, België, 5530
- CHU UCL Namur - Site Godinne
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, België, 9000
- UZ Gent
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Araucania
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Temuco, Araucania, Chili, 4780000
- Centro de especialidades médicas Vanguardia
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Región-MetropolitanadeSantiago
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Santiago, Región-MetropolitanadeSantiago, Chili, 8260094
- Hospital Padre Hurtado
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Santiago, Región-MetropolitanadeSantiago, Chili, 8320000
- BIOCINETIC Ltda
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Santiago, Región-MetropolitanadeSantiago, Chili, 8320000
- Centro de Investigacion Clinica UC
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Valparaiso
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Viña del Mar, Valparaiso, Chili, 2520021
- Instituto Neurologico Thalamus
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Rennes, Frankrijk, 35033
- Hôpital Pontchaillou
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Bas-Rhin
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Strasbourg, Bas-Rhin, Frankrijk, 67000
- CHU de Strasbourg - Hôpital de Hautepierre
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Côte-d'Or
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Dijon, Côte-d'Or, Frankrijk, 21000
- CHU Dijon Bourgogne
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankrijk, 31059
- CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
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Hérault
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Montpellier, Hérault, Frankrijk, 34295
- CHU de Montpellier- Hôpital Gui De Chauliac
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Indre-et-Loire
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Tours, Indre-et-Loire, Frankrijk, 37000
- CHRU de Tours - Hôpital Bretonneau
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Meurthe-et-Moselle
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Nancy, Meurthe-et-Moselle, Frankrijk, 54000
- CHRU Nancy
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Nord
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Lille, Nord, Frankrijk, 59037
- CHU de Lille - Hopital Claude Huriez
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Rhône
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Lyon, Rhône, Frankrijk, 69003
- Hospices Civils de Lyon - 59 Bd Pinel
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Budapest, Hongarije, 1145
- SE INK Juhasz Pal Epilepszia Központ
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Budapest, Hongarije, 1106
- Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
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Baranya
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Pécs, Baranya, Hongarije, 7623
- Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
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Hajdú-Bihar
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Debrecen, Hajdú-Bihar, Hongarije, 4031
- Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus
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North Brabant
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Heeze, North Brabant, Nederland, 5591 VE
- Kempenhaeghe - PPDS
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North Holland
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Heemstede, North Holland, Nederland, 2103 SW
- Stichting Epilepsie Instellingen Nederland - Heemstede
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Overijssel
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Zwolle, Overijssel, Nederland, 8025 BV
- Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20
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Salzburg, Oostenrijk, 5020
- Christian Doppler-Klinik - Universitätsklinikum der PMU
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Sankt Pölten, Oostenrijk, 3100
- Universitätsklinikum St. Pölten
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Vienna, Oostenrijk, 1090
- Medizinische Universitat Wien (Medical University of Vienna)
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Upper Austria
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Linz, Upper Austria, Oostenrijk, 4020
- Kepler Universitätsklinikum Linz - Med Campus III
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Gdansk, Polen, 80-803
- Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6
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Katowice, Polen, 40-594
- Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44
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Krakow, Polen, 31-156
- LANDA Specjalistyczne Gabinety Lekarskie
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Krakow, Polen, 30-727
- Pratia MCM Kraków
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polen, 60-702
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polen, 20-078
- Clinical Best Solutions - Lublin
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Świdnik, Lublin Voivodeship, Polen, 21-040
- NZOZ IGNIS dr med. Alicja Lobinska
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Lubusz Voivodeship
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Nowa Sól, Lubusz Voivodeship, Polen, 67-100
- Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
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Lódzkie
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Lodz, Lódzkie, Polen, 90-302
- Santa Familia PTG Lodz
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 02-172
- MTZ Clinical Research Powered by PRATIA - PPDS
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Warsaw, Masovian Voivodeship, Polen, 02-829
- Neurosphera SP. Z O.O
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Warsaw, Masovian Voivodeship, Polen, 02-957
- Instytut Psychiatrii i Neurologii
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polen, 80-546
- Centrum Badan Klinicznych PI-House sp. z o.o.
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Maribor, Slovenië, 2000
- University Clinical Centre Maribor
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South Moravian
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Brno, South Moravian, Tsjechië, 602 00
- Fakultni nemocnice u sv. Anny v Brne
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85013
- Barrow Neurological Institute
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Tucson, Arizona, Verenigde Staten, 85718
- Center for Neurosciences
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72205
- Clinical Trials, Inc.
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California
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La Jolla, California, Verenigde Staten, 92041
- University of California San Diego
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Los Angeles, California, Verenigde Staten, 90095
- University of California, Los Angeles
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Palo Alto, California, Verenigde Staten, 94304
- Stanford Health Care
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Pasadena, California, Verenigde Staten, 91105
- Profound Research LLC
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- University of Colorado Anschultz Medical Campus
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Connecticut
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New Haven, Connecticut, Verenigde Staten, 06519
- Yale School of Medicine - Yale-New Haven Hospital
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Florida
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Boca Raton, Florida, Verenigde Staten, 33486
- EZR Research LLC
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Bradenton, Florida, Verenigde Staten, 34209
- Nova Clinical Research, LLC
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Jacksonville, Florida, Verenigde Staten, 32209
- University of Florida (Jacksonville)
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Miami, Florida, Verenigde Staten, 33136
- University of Miami
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Port Charlotte, Florida, Verenigde Staten, 33952
- Medsol Clinical Research Center
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Tampa, Florida, Verenigde Staten, 33615
- Santos Research Center
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Weston, Florida, Verenigde Staten, 33331
- Encore Medical Research of Weston LLC.
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Georgia
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Augusta, Georgia, Verenigde Staten, 30912
- Augusta University
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96817
- Hawaii Pacific Neuroscience
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Idaho
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Boise, Idaho, Verenigde Staten, 83702
- Consultants in Epilepsy & Neurology, PLLC
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- Northwestern University
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Elgin, Illinois, Verenigde Staten, 60123
- Revive Research Institute, Inc.
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40504
- Bluegrass Epilepsy Research
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Maryland
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Bethesda, Maryland, Verenigde Staten, 20817
- MAESC
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Silver Spring, Maryland, Verenigde Staten, 20901
- Javara
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Minnesota
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Roseville, Minnesota, Verenigde Staten, 55113
- Minnesota Epilepsy Group, P.A.
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Missouri
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St Louis, Missouri, Verenigde Staten, 63110
- Washington University School of Medicine
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New Jersey
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Hackensack, New Jersey, Verenigde Staten, 07601
- NEREG
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Livingston, New Jersey, Verenigde Staten, 07039
- Inst of Neurology
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New York
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Amherst, New York, Verenigde Staten, 14226
- Dent Neurosciences Research Center
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Hawthorne, New York, Verenigde Staten, 10532
- BCHP
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New York, New York, Verenigde Staten, 10021
- Northwell Health
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Stony Brook, New York, Verenigde Staten, 11794
- Stony Brook Medicine
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Woodmere, New York, Verenigde Staten, 11598
- Five Towns Neuroscience Research
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North Carolina
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Winston-Salem, North Carolina, Verenigde Staten, 27157
- Wake Forest Baptist
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Ohio
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Canton, Ohio, Verenigde Staten, 44718
- NeuroScience Research Center
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Cincinnati, Ohio, Verenigde Staten, 45267
- University of Cincinnati
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Columbus, Ohio, Verenigde Staten, 43214
- OSU
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- University of Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- UPMC
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Verenigde Staten, 75243
- Neurology Consultants of Dallas, PA
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Fort Worth, Texas, Verenigde Staten, 76104
- Tarrant Neurology Consultants
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San Antonio, Texas, Verenigde Staten, 78229
- UT Health San Antonio
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San Antonio, Texas, Verenigde Staten, 78249
- Road Runner Research, Ltd
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84132
- University of Utah
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Virginia
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Charlottesville, Virginia, Verenigde Staten, 22903
- University of Virginia
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Richmond, Virginia, Verenigde Staten, 23235
- Henrico Doctors Neurology Associates, LLC
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Roanoke, Virginia, Verenigde Staten, 24011
- Carilion Clinic
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Zürich (de)
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Zurich, Zürich (de), Zwitserland, 8008
- Klinik Lengg AG
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Key Inclusion Criteria:
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Male and Female participants 18 to 75 years of age at time of consent.
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Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.
a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures iii. Focal to bilateral tonic-clonic seizures
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Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
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Ability to keep accurate seizure diaries
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Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total
Key Exclusion Criteria:
- History of status epilepticus (convulsive status epilepticus for > 5 minutes or focal status epilepticus with impaired consciousness 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 seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
- Resection neurosurgery for seizures <4 months prior to the screening visit.
- Radiosurgery performed <2 years prior to the screening visit.
- Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms.
- Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: BHV-7000 25 mg Deel A
|
BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily |
|
Experimenteel: BHV-7000 50 mg Deel A
|
BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily |
|
Placebo-vergelijker: Placebo Deel A
|
Matching placebo taken once daily |
|
Experimenteel: BHV-7000 75 mg Deel B
|
BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily |
|
Placebo-vergelijker: Placebo Deel B
|
Matching placebo taken once daily |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Part B: Change from Baseline in 28-day average seizure frequency
Tijdsspanne: Baseline, Week 8 to Week 20 of Part B
|
To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 12-week double-blind treatment phase. |
Baseline, Week 8 to Week 20 of Part B
|
|
Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Tijdsspanne: Week 8 to Week 20 of Part A
|
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs. |
Week 8 to Week 20 of Part A
|
|
Part A: Number of Participants With Clinically Significant Laboratory Abnormalities
Tijdsspanne: Week 8 to Week 20 of Part A
|
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities. |
Week 8 to Week 20 of Part A
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month
Tijdsspanne: Baseline, Week 8 to Week 20 of Part B
|
To compare the efficacy of 2 dose strengths of BHV-7000 to placebo as adjunctive therapy for refractory focal onset epilepsy as measured by the proportion of subjects that have at least a 50% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the 12 week double-blind phase to the observation phase. |
Baseline, Week 8 to Week 20 of Part B
|
|
Part B: Change from Baseline in 28-day average seizure frequency during first month of treatment
Tijdsspanne: Baseline, Week 8 to Week 12 of Part B
|
To compare the efficacy of BHV-7000 to placebo during the first month of treatment. This objective will be measured by the change in log-transformed 28-day adjusted seizure frequency from observation phase over the first month of the double blind phase. |
Baseline, Week 8 to Week 12 of Part B
|
|
Part B: Percentage of Participants with at at least 75% reduction in seizure frequency per month
Tijdsspanne: Baseline, Week 8 to Week 20 of Part B
|
To compare the efficacy of BHV-7000 to placebo as measured by the proportion of subjects that have at least a 75% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the double-blind phase compared to the observation phase. |
Baseline, Week 8 to Week 20 of Part B
|
|
Part B: Percentage of Participants with seizure freedom during DB Phase
Tijdsspanne: Week 8 to Week 20 of Part B
|
To compare the efficacy of BHV-7000 to placebo on seizure freedom (100% seizure reduction during the DB phase). This objective will be measured by proportion of subjects that are seizure free during the double-blind phase. |
Week 8 to Week 20 of Part B
|
|
Part B: Change from baseline in 7-day adjusted seizure frequency during first week of treatment
Tijdsspanne: Baseline, Week 8 to Week 9 of Part B
|
To compare the efficacy of BHV-7000 to placebo during the first week of treatment. This objective will be measured by the change in log-transformed 7-day adjusted seizure frequency from observation phase over the first week of the double-blind phase. |
Baseline, Week 8 to Week 9 of Part B
|
|
Part B: Change from baseline in Patient Global Impression of Change (PGI-C)
Tijdsspanne: Baseline, Week 20 of Part B
|
To compare the efficacy of BHV-7000 to placebo on the patient global impression of change (PGI-C). This objective will be measured by proportion of subjects at week 12 of double-blind treatment phase with a PGI-C response of "minimally improved", "much improved" or "very much improved". This scale is a 7-point Likert scale with response options of: (1) "very much improved" , (2) "much improved", (3) "minimally improved", (4) "no change", (5) "minimally worse", (6) "much worse", (7) and "very much worse" |
Baseline, Week 20 of Part B
|
|
Part B: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Tijdsspanne: Week 8 to Week 20 of Part B
|
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs. |
Week 8 to Week 20 of Part B
|
|
Part B: Number of Participants With Clinically Significant Laboratory Abnormalities
Tijdsspanne: Week 8 to Week 20 of Part B
|
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities. |
Week 8 to Week 20 of Part B
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BHV7000-302
- 2023-508539-30 (Register-ID: EU CTR)
- 2023 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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