BHV-7000이 불응성 초점 발병 간질이 있는 성인에게 효과적이고 안전한지 확인하기 위한 연구 (RISE 2)
불응성 국소 발병 간질 환자를 대상으로 BHV-7000의 효능, 안전성 및 내약성을 평가하기 위한 2/3상 다기관, 무작위 배정, 이중 맹검, 위약 대조 연구
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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North Brabant
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Heeze, North Brabant, 네덜란드, 5591 VE
- Kempenhaeghe - PPDS
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North Holland
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Heemstede, North Holland, 네덜란드, 2103 SW
- Stichting Epilepsie Instellingen Nederland - Heemstede
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Overijssel
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Zwolle, Overijssel, 네덜란드, 8025 BV
- Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20
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Arizona
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Phoenix, Arizona, 미국, 85013
- Barrow Neurological Institute
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Tucson, Arizona, 미국, 85718
- Center for Neurosciences
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- Clinical Trials, Inc.
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California
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La Jolla, California, 미국, 92041
- University of California San Diego
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Los Angeles, California, 미국, 90095
- University of California, Los Angeles
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Palo Alto, California, 미국, 94304
- Stanford Health Care
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Pasadena, California, 미국, 91105
- Profound Research LLC
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Colorado
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Aurora, Colorado, 미국, 80045
- University of Colorado Anschultz Medical Campus
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Connecticut
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New Haven, Connecticut, 미국, 06519
- Yale School of Medicine - Yale-New Haven Hospital
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Florida
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Boca Raton, Florida, 미국, 33486
- EZR Research LLC
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Bradenton, Florida, 미국, 34209
- Nova Clinical Research, LLC
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Jacksonville, Florida, 미국, 32209
- University of Florida (Jacksonville)
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Miami, Florida, 미국, 33136
- University of Miami
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Port Charlotte, Florida, 미국, 33952
- Medsol Clinical Research Center
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Tampa, Florida, 미국, 33615
- Santos Research Center
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Weston, Florida, 미국, 33331
- Encore Medical Research of Weston LLC.
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Georgia
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Augusta, Georgia, 미국, 30912
- Augusta University
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Hawaii
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Honolulu, Hawaii, 미국, 96817
- Hawaii Pacific Neuroscience
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Idaho
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Boise, Idaho, 미국, 83702
- Consultants in Epilepsy & Neurology, PLLC
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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Elgin, Illinois, 미국, 60123
- Revive Research Institute, Inc.
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Kentucky
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Lexington, Kentucky, 미국, 40504
- Bluegrass Epilepsy Research
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Maryland
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Bethesda, Maryland, 미국, 20817
- MAESC
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Silver Spring, Maryland, 미국, 20901
- Javara
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Minnesota
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Roseville, Minnesota, 미국, 55113
- Minnesota Epilepsy Group, P.A.
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Missouri
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St Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- NEREG
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Livingston, New Jersey, 미국, 07039
- Inst of Neurology
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New York
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Amherst, New York, 미국, 14226
- Dent Neurosciences Research Center
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Hawthorne, New York, 미국, 10532
- BCHP
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New York, New York, 미국, 10021
- Northwell Health
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Stony Brook, New York, 미국, 11794
- Stony Brook Medicine
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Woodmere, New York, 미국, 11598
- Five Towns Neuroscience Research
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North Carolina
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Winston-Salem, North Carolina, 미국, 27157
- Wake Forest Baptist
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Ohio
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Canton, Ohio, 미국, 44718
- NeuroScience Research Center
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Cincinnati, Ohio, 미국, 45267
- University of Cincinnati
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Columbus, Ohio, 미국, 43214
- OSU
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, 미국, 15213
- UPMC
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Tennessee
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Nashville, Tennessee, 미국, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, 미국, 75243
- Neurology Consultants of Dallas, PA
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Fort Worth, Texas, 미국, 76104
- Tarrant Neurology Consultants
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San Antonio, Texas, 미국, 78229
- UT Health San Antonio
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San Antonio, Texas, 미국, 78249
- Road Runner Research, Ltd
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Utah
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Salt Lake City, Utah, 미국, 84132
- University of Utah
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Virginia
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Charlottesville, Virginia, 미국, 22903
- University of Virginia
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Richmond, Virginia, 미국, 23235
- Henrico Doctors Neurology Associates, LLC
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Roanoke, Virginia, 미국, 24011
- Carilion Clinic
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Antwerpen
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Edegem, Antwerpen, 벨기에, 2650
- UZ Antwerpen
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Brussels Capital
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Anderlecht, Brussels Capital, 벨기에, 1070
- Hôpital Erasme
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Brussels, Brussels Capital, 벨기에, 1200
- Cliniques Universitaires Saint-Luc
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Namur
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Yvoir, Namur, 벨기에, 5530
- CHU UCL Namur - Site Godinne
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, 벨기에, 9000
- UZ Gent
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Zürich (de)
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Zurich, Zürich (de), 스위스, 8008
- Klinik Lengg AG
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Maribor, 슬로베니아, 2000
- University Clinical Centre Maribor
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Buenos Aires, 아르헨티나, C1181ACH
- Hospital Italiano de Buenos Aires
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Buenos Aires, 아르헨티나, C1428AQK
- Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
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Buenos Aires, 아르헨티나, C1039AAO
- Sanatorio de la Trinidad - Mitre
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Córdoba, 아르헨티나, X5004AOA
- Instituto Privado Kremer
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Córdoba, 아르헨티나, X5008HHW
- Conci Carpinella - Santa Rosa N° 748
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Buenos Aires
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Ciudad Autónoma de Buenos Aires, Buenos Aires, 아르헨티나, C1013AAB
- STAT Research S.A.
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Ciudad Autónoma de BuenosAires
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Balvanera, Ciudad Autónoma de BuenosAires, 아르헨티나, C1221ADC
- Hospital General de Agudos Dr. José María Ramos Mejia
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Buenos Aires, Ciudad Autónoma de BuenosAires, 아르헨티나, C1437JCH
- Hospital Británico de Buenos Aires
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, 아르헨티나, T4000AXL
- Investigaciones Sanatorio Del Sur
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Salzburg, 오스트리아, 5020
- Christian Doppler-Klinik - Universitätsklinikum der PMU
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Sankt Pölten, 오스트리아, 3100
- Universitätsklinikum St. Pölten
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Vienna, 오스트리아, 1090
- Medizinische Universitat Wien (Medical University of Vienna)
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Upper Austria
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Linz, Upper Austria, 오스트리아, 4020
- Kepler Universitätsklinikum Linz - Med Campus III
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South Moravian
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Brno, South Moravian, 체코, 602 00
- Fakultni nemocnice u sv. Anny v Brne
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Araucania
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Temuco, Araucania, 칠레, 4780000
- Centro de especialidades médicas Vanguardia
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Región-MetropolitanadeSantiago
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Santiago, Región-MetropolitanadeSantiago, 칠레, 8260094
- Hospital Padre Hurtado
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Santiago, Región-MetropolitanadeSantiago, 칠레, 8320000
- BIOCINETIC Ltda
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Santiago, Región-MetropolitanadeSantiago, 칠레, 8320000
- Centro de Investigacion Clinica UC
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Valparaiso
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Viña del Mar, Valparaiso, 칠레, 2520021
- Instituto Neurologico Thalamus
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Gdansk, 폴란드, 80-803
- Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6
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Katowice, 폴란드, 40-594
- Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44
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Krakow, 폴란드, 31-156
- LANDA Specjalistyczne Gabinety Lekarskie
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Krakow, 폴란드, 30-727
- Pratia MCM Kraków
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, 폴란드, 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, 폴란드, 20-078
- Clinical Best Solutions - Lublin
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Świdnik, Lublin Voivodeship, 폴란드, 21-040
- NZOZ IGNIS dr med. Alicja Lobinska
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Lubusz Voivodeship
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Nowa Sól, Lubusz Voivodeship, 폴란드, 67-100
- Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
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Lódzkie
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Lodz, Lódzkie, 폴란드, 90-302
- Santa Familia PTG Lodz
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, 폴란드, 02-172
- MTZ Clinical Research Powered by PRATIA - PPDS
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Warsaw, Masovian Voivodeship, 폴란드, 02-829
- Neurosphera SP. Z O.O
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Warsaw, Masovian Voivodeship, 폴란드, 02-957
- Instytut Psychiatrii i Neurologii
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, 폴란드, 80-546
- Centrum Badan Klinicznych PI-House sp. z o.o.
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Rennes, 프랑스, 35033
- Hôpital Pontchaillou
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Bas-Rhin
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Strasbourg, Bas-Rhin, 프랑스, 67000
- CHU de Strasbourg - Hôpital de Hautepierre
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Côte-d'Or
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Dijon, Côte-d'Or, 프랑스, 21000
- CHU Dijon Bourgogne
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Haute-Garonne
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Toulouse, Haute-Garonne, 프랑스, 31059
- CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
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Hérault
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Montpellier, Hérault, 프랑스, 34295
- CHU de Montpellier- Hôpital Gui De Chauliac
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Indre-et-Loire
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Tours, Indre-et-Loire, 프랑스, 37000
- CHRU de Tours - Hôpital Bretonneau
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Meurthe-et-Moselle
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Nancy, Meurthe-et-Moselle, 프랑스, 54000
- CHRU Nancy
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Nord
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Lille, Nord, 프랑스, 59037
- CHU de Lille - Hopital Claude Huriez
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Rhône
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Lyon, Rhône, 프랑스, 69003
- Hospices Civils de Lyon - 59 Bd Pinel
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Budapest, 헝가리, 1145
- SE INK Juhasz Pal Epilepszia Központ
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Budapest, 헝가리, 1106
- Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
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Baranya
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Pécs, Baranya, 헝가리, 7623
- Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
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Hajdú-Bihar
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Debrecen, Hajdú-Bihar, 헝가리, 4031
- Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
-
Male and Female participants 18 to 75 years of age at time of consent.
-
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
-
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.
-
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: BHV-7000 25 mg 파트 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 |
|
실험적: BHV-7000 50 mg 파트 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 |
|
위약 비교기: 위약 파트 A
|
Matching placebo taken once daily |
|
실험적: BHV-7000 75 mg 파트 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 |
|
위약 비교기: 플라시보 파트 B
|
Matching placebo taken once daily |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part B: Change from Baseline in 28-day average seizure frequency
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- BHV7000-302
- 2023-508539-30 (레지스트리 식별자: EU CTR)
- 2023 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
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