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En studie for å avgjøre om BHV-7000 er effektiv og sikker hos voksne med refraktær fokal epilepsi (RISE 2)

28. september 2026 oppdatert av: Biohaven Therapeutics Ltd.

En fase 2/3 multisenter, randomisert, dobbeltblind, placebokontrollert studie for å evaluere effektiviteten, sikkerheten og tolerabiliteten til BHV-7000 hos personer med refraktær fokal epilepsi

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

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

390

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: BHV-7000 25 mg del A
Legemiddel: BHV-7000

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

Legemiddel: BHV-7000

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

Legemiddel: BHV-7000

BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
Eksperimentell: BHV-7000 50 mg Del A
Legemiddel: BHV-7000

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

Legemiddel: BHV-7000

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

Legemiddel: BHV-7000

BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
Placebo komparator: Placebo Del A
Legemiddel: Placebo

Matching placebo taken once daily
Eksperimentell: BHV-7000 75 mg Del B
Legemiddel: BHV-7000

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

Legemiddel: BHV-7000

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

Legemiddel: BHV-7000

BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
Placebo komparator: Placebo del B
Legemiddel: Placebo

Matching placebo taken once daily

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Part B: Change from Baseline in 28-day average seizure frequency
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Biohaven Therapeutics Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. mars 2024

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

10. november 2023

Først innsendt som oppfylte QC-kriteriene

10. november 2023

Først lagt ut (Faktiske)

15. november 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BHV7000-302
  • 2023-508539-30 (Registeridentifikator: EU CTR)
  • 2023 (U.S. NIH-stipend/kontrakt)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere