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Un estudio para determinar si BHV-7000 es eficaz y seguro en adultos con epilepsia de inicio focal refractaria (RISE 2)

28 de septiembre de 2026 actualizado por: Biohaven Therapeutics Ltd.

Un estudio de fase 2/3 multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad del BHV-7000 en sujetos con epilepsia de inicio focal refractaria

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

390

Fase

  • Fase 2
  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, C1428AQK
        • Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
      • Buenos Aires, Argentina, C1039AAO
        • Sanatorio de la Trinidad - Mitre
      • Córdoba, Argentina, X5004AOA
        • Instituto Privado Kremer
      • Córdoba, Argentina, X5008HHW
        • Conci Carpinella - Santa Rosa N° 748
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1013AAB
        • STAT Research S.A.
    • Ciudad Autónoma de BuenosAires
      • Balvanera, Ciudad Autónoma de BuenosAires, Argentina, C1221ADC
        • Hospital General de Agudos Dr. José María Ramos Mejia
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1437JCH
        • Hospital Británico de Buenos Aires
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • Investigaciones Sanatorio Del Sur
  • Austria
      • Salzburg, Austria, 5020
        • Christian Doppler-Klinik - Universitätsklinikum der PMU
      • Sankt Pölten, Austria, 3100
        • Universitätsklinikum St. Pölten
      • Vienna, Austria, 1090
        • Medizinische Universitat Wien (Medical University of Vienna)
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Kepler Universitätsklinikum Linz - Med Campus III
  • Bélgica
    • Antwerpen
      • Edegem, Antwerpen, Bélgica, 2650
        • UZ Antwerpen
    • Brussels Capital
      • Anderlecht, Brussels Capital, Bélgica, 1070
        • Hôpital Erasme
      • Brussels, Brussels Capital, Bélgica, 1200
        • Cliniques Universitaires Saint-Luc
    • Namur
      • Yvoir, Namur, Bélgica, 5530
        • CHU UCL Namur - Site Godinne
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Bélgica, 9000
        • UZ Gent
  • Chequia
    • South Moravian
      • Brno, South Moravian, Chequia, 602 00
        • Fakultni nemocnice u sv. Anny v Brne
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4780000
        • Centro de especialidades médicas Vanguardia
    • Región-MetropolitanadeSantiago
      • Santiago, Región-MetropolitanadeSantiago, Chile, 8260094
        • Hospital Padre Hurtado
      • Santiago, Región-MetropolitanadeSantiago, Chile, 8320000
        • BIOCINETIC Ltda
      • Santiago, Región-MetropolitanadeSantiago, Chile, 8320000
        • Centro de Investigacion Clinica UC
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520021
        • Instituto Neurologico Thalamus
  • Eslovenia
      • Maribor, Eslovenia, 2000
        • University Clinical Centre Maribor
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85013
        • Barrow Neurological Institute
      • Tucson, Arizona, Estados Unidos, 85718
        • Center for Neurosciences
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72205
        • Clinical Trials, Inc.
    • California
      • La Jolla, California, Estados Unidos, 92041
        • University of California San Diego
      • Los Angeles, California, Estados Unidos, 90095
        • University of California, Los Angeles
      • Palo Alto, California, Estados Unidos, 94304
        • Stanford Health Care
      • Pasadena, California, Estados Unidos, 91105
        • Profound Research LLC
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • University of Colorado Anschultz Medical Campus
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06519
        • Yale School of Medicine - Yale-New Haven Hospital
    • Florida
      • Boca Raton, Florida, Estados Unidos, 33486
        • EZR Research LLC
      • Bradenton, Florida, Estados Unidos, 34209
        • Nova Clinical Research, LLC
      • Jacksonville, Florida, Estados Unidos, 32209
        • University of Florida (Jacksonville)
      • Miami, Florida, Estados Unidos, 33136
        • University of Miami
      • Port Charlotte, Florida, Estados Unidos, 33952
        • Medsol Clinical Research Center
      • Tampa, Florida, Estados Unidos, 33615
        • Santos Research Center
      • Weston, Florida, Estados Unidos, 33331
        • Encore Medical Research of Weston LLC.
    • Georgia
      • Augusta, Georgia, Estados Unidos, 30912
        • Augusta University
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96817
        • Hawaii Pacific Neuroscience
    • Idaho
      • Boise, Idaho, Estados Unidos, 83702
        • Consultants in Epilepsy & Neurology, PLLC
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern University
      • Elgin, Illinois, Estados Unidos, 60123
        • Revive Research Institute, Inc.
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40504
        • Bluegrass Epilepsy Research
    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20817
        • MAESC
      • Silver Spring, Maryland, Estados Unidos, 20901
        • Javara
    • Minnesota
      • Roseville, Minnesota, Estados Unidos, 55113
        • Minnesota Epilepsy Group, P.A.
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine
    • New Jersey
      • Hackensack, New Jersey, Estados Unidos, 07601
        • NEREG
      • Livingston, New Jersey, Estados Unidos, 07039
        • Inst of Neurology
    • New York
      • Amherst, New York, Estados Unidos, 14226
        • Dent Neurosciences Research Center
      • Hawthorne, New York, Estados Unidos, 10532
        • BCHP
      • New York, New York, Estados Unidos, 10021
        • Northwell Health
      • Stony Brook, New York, Estados Unidos, 11794
        • Stony Brook Medicine
      • Woodmere, New York, Estados Unidos, 11598
        • Five Towns Neuroscience Research
    • North Carolina
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Wake Forest Baptist
    • Ohio
      • Canton, Ohio, Estados Unidos, 44718
        • NeuroScience Research Center
      • Cincinnati, Ohio, Estados Unidos, 45267
        • University of Cincinnati
      • Columbus, Ohio, Estados Unidos, 43214
        • OSU
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • UPMC
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, Estados Unidos, 75243
        • Neurology Consultants of Dallas, PA
      • Fort Worth, Texas, Estados Unidos, 76104
        • Tarrant Neurology Consultants
      • San Antonio, Texas, Estados Unidos, 78229
        • UT Health San Antonio
      • San Antonio, Texas, Estados Unidos, 78249
        • Road Runner Research, Ltd
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84132
        • University of Utah
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903
        • University of Virginia
      • Richmond, Virginia, Estados Unidos, 23235
        • Henrico Doctors Neurology Associates, LLC
      • Roanoke, Virginia, Estados Unidos, 24011
        • Carilion Clinic
  • Francia
      • Rennes, Francia, 35033
        • Hôpital Pontchaillou
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, Francia, 67000
        • CHU de Strasbourg - Hôpital de Hautepierre
    • Côte-d'Or
      • Dijon, Côte-d'Or, Francia, 21000
        • CHU Dijon Bourgogne
    • Haute-Garonne
      • Toulouse, Haute-Garonne, Francia, 31059
        • CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
    • Hérault
      • Montpellier, Hérault, Francia, 34295
        • CHU de Montpellier- Hôpital Gui De Chauliac
    • Indre-et-Loire
      • Tours, Indre-et-Loire, Francia, 37000
        • CHRU de Tours - Hôpital Bretonneau
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, Francia, 54000
        • CHRU Nancy
    • Nord
      • Lille, Nord, Francia, 59037
        • CHU de Lille - Hopital Claude Huriez
    • Rhône
      • Lyon, Rhône, Francia, 69003
        • Hospices Civils de Lyon - 59 Bd Pinel
  • Hungría
      • Budapest, Hungría, 1145
        • SE INK Juhasz Pal Epilepszia Központ
      • Budapest, Hungría, 1106
        • Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
    • Baranya
      • Pécs, Baranya, Hungría, 7623
        • Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungría, 4031
        • Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus
  • Países Bajos
    • North Brabant
      • Heeze, North Brabant, Países Bajos, 5591 VE
        • Kempenhaeghe - PPDS
    • North Holland
      • Heemstede, North Holland, Países Bajos, 2103 SW
        • Stichting Epilepsie Instellingen Nederland - Heemstede
    • Overijssel
      • Zwolle, Overijssel, Países Bajos, 8025 BV
        • Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20
  • Polonia
      • Gdansk, Polonia, 80-803
        • Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6
      • Katowice, Polonia, 40-594
        • Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44
      • Krakow, Polonia, 31-156
        • LANDA Specjalistyczne Gabinety Lekarskie
      • Krakow, Polonia, 30-727
        • Pratia MCM Kraków
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polonia, 60-702
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polonia, 20-078
        • Clinical Best Solutions - Lublin
      • Świdnik, Lublin Voivodeship, Polonia, 21-040
        • NZOZ IGNIS dr med. Alicja Lobinska
    • Lubusz Voivodeship
      • Nowa Sól, Lubusz Voivodeship, Polonia, 67-100
        • Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
    • Lódzkie
      • Lodz, Lódzkie, Polonia, 90-302
        • Santa Familia PTG Lodz
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polonia, 02-172
        • MTZ Clinical Research Powered by PRATIA - PPDS
      • Warsaw, Masovian Voivodeship, Polonia, 02-829
        • Neurosphera SP. Z O.O
      • Warsaw, Masovian Voivodeship, Polonia, 02-957
        • Instytut Psychiatrii i Neurologii
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polonia, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Suiza
    • Zürich (de)
      • Zurich, Zürich (de), Suiza, 8008
        • Klinik Lengg AG

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Key Inclusion Criteria:

  1. Male and Female participants 18 to 75 years of age at time of consent.

  2. 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

  3. 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.

  4. Ability to keep accurate seizure diaries

  5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total

Key Exclusion Criteria:

  1. 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.
  2. History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
  3. Resection neurosurgery for seizures <4 months prior to the screening visit.
  4. Radiosurgery performed <2 years prior to the screening visit.
  5. 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.
  6. 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: BHV-7000 25 mg Parte A
Droga: BHV-7000

BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily

Droga: BHV-7000

BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily

Droga: BHV-7000

BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
Experimental: BHV-7000 50 mg Parte A
Droga: BHV-7000

BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily

Droga: BHV-7000

BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily

Droga: BHV-7000

BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
Comparador de placebos: Placebo Parte A
Droga: Placebo

Matching placebo taken once daily
Experimental: BHV-7000 75 mg Parte B
Droga: BHV-7000

BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily

Droga: BHV-7000

BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily

Droga: BHV-7000

BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
Comparador de placebos: Placebo Parte B
Droga: Placebo

Matching placebo taken once daily

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part B: Change from Baseline in 28-day average seizure frequency
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Biohaven Therapeutics Ltd.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de marzo de 2024

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

10 de noviembre de 2023

Primero enviado que cumplió con los criterios de control de calidad

10 de noviembre de 2023

Publicado por primera vez (Actual)

15 de noviembre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BHV7000-302
  • 2023-508539-30 (Identificador de registro: EU CTR)
  • 2023 (Subvención/contrato del NIH de EE. UU.)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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