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En undersøgelse for at afgøre, om BHV-7000 er effektiv og sikker hos voksne med refraktær focal onset epilepsi (RISE 2)

28. september 2026 opdateret af: Biohaven Therapeutics Ltd.

Et fase 2/3 multicenter, randomiseret, dobbeltblindt, placebokontrolleret, undersøgelse for at evaluere effektiviteten, sikkerheden og tolerabiliteten af ​​BHV-7000 hos forsøgspersoner med refraktær fokal epilepsi

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

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

390

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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
  • Belgien
    • Antwerpen
      • Edegem, Antwerpen, Belgien, 2650
        • UZ Antwerpen
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgien, 1070
        • Hôpital Erasme
      • Brussels, Brussels Capital, Belgien, 1200
        • Cliniques Universitaires Saint-Luc
    • Namur
      • Yvoir, Namur, Belgien, 5530
        • CHU UCL Namur - Site Godinne
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgien, 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
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85013
        • Barrow Neurological Institute
      • Tucson, Arizona, Forenede Stater, 85718
        • Center for Neurosciences
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Clinical Trials, Inc.
    • California
      • La Jolla, California, Forenede Stater, 92041
        • University of California San Diego
      • Los Angeles, California, Forenede Stater, 90095
        • University of California, Los Angeles
      • Palo Alto, California, Forenede Stater, 94304
        • Stanford Health Care
      • Pasadena, California, Forenede Stater, 91105
        • Profound Research LLC
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado Anschultz Medical Campus
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06519
        • Yale School of Medicine - Yale-New Haven Hospital
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33486
        • EZR Research LLC
      • Bradenton, Florida, Forenede Stater, 34209
        • Nova Clinical Research, LLC
      • Jacksonville, Florida, Forenede Stater, 32209
        • University of Florida (Jacksonville)
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami
      • Port Charlotte, Florida, Forenede Stater, 33952
        • Medsol Clinical Research Center
      • Tampa, Florida, Forenede Stater, 33615
        • Santos Research Center
      • Weston, Florida, Forenede Stater, 33331
        • Encore Medical Research of Weston LLC.
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Augusta University
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Hawaii Pacific Neuroscience
    • Idaho
      • Boise, Idaho, Forenede Stater, 83702
        • Consultants in Epilepsy & Neurology, PLLC
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
      • Elgin, Illinois, Forenede Stater, 60123
        • Revive Research Institute, Inc.
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40504
        • Bluegrass Epilepsy Research
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20817
        • MAESC
      • Silver Spring, Maryland, Forenede Stater, 20901
        • Javara
    • Minnesota
      • Roseville, Minnesota, Forenede Stater, 55113
        • Minnesota Epilepsy Group, P.A.
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • NEREG
      • Livingston, New Jersey, Forenede Stater, 07039
        • Inst of Neurology
    • New York
      • Amherst, New York, Forenede Stater, 14226
        • Dent Neurosciences Research Center
      • Hawthorne, New York, Forenede Stater, 10532
        • BCHP
      • New York, New York, Forenede Stater, 10021
        • Northwell Health
      • Stony Brook, New York, Forenede Stater, 11794
        • Stony Brook Medicine
      • Woodmere, New York, Forenede Stater, 11598
        • Five Towns Neuroscience Research
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest Baptist
    • Ohio
      • Canton, Ohio, Forenede Stater, 44718
        • NeuroScience Research Center
      • Cincinnati, Ohio, Forenede Stater, 45267
        • University of Cincinnati
      • Columbus, Ohio, Forenede Stater, 43214
        • OSU
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • UPMC
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, Forenede Stater, 75243
        • Neurology Consultants of Dallas, PA
      • Fort Worth, Texas, Forenede Stater, 76104
        • Tarrant Neurology Consultants
      • San Antonio, Texas, Forenede Stater, 78229
        • UT Health San Antonio
      • San Antonio, Texas, Forenede Stater, 78249
        • Road Runner Research, Ltd
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • University of Utah
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22903
        • University of Virginia
      • Richmond, Virginia, Forenede Stater, 23235
        • Henrico Doctors Neurology Associates, LLC
      • Roanoke, Virginia, Forenede Stater, 24011
        • Carilion Clinic
  • Frankrig
      • Rennes, Frankrig, 35033
        • Hôpital Pontchaillou
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, Frankrig, 67000
        • CHU de Strasbourg - Hôpital de Hautepierre
    • Côte-d'Or
      • Dijon, Côte-d'Or, Frankrig, 21000
        • CHU Dijon Bourgogne
    • Haute-Garonne
      • Toulouse, Haute-Garonne, Frankrig, 31059
        • CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
    • Hérault
      • Montpellier, Hérault, Frankrig, 34295
        • CHU de Montpellier- Hôpital Gui De Chauliac
    • Indre-et-Loire
      • Tours, Indre-et-Loire, Frankrig, 37000
        • CHRU de Tours - Hôpital Bretonneau
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, Frankrig, 54000
        • CHRU Nancy
    • Nord
      • Lille, Nord, Frankrig, 59037
        • CHU de Lille - Hopital Claude Huriez
    • Rhône
      • Lyon, Rhône, Frankrig, 69003
        • Hospices Civils de Lyon - 59 Bd Pinel
  • Holland
    • North Brabant
      • Heeze, North Brabant, Holland, 5591 VE
        • Kempenhaeghe - PPDS
    • North Holland
      • Heemstede, North Holland, Holland, 2103 SW
        • Stichting Epilepsie Instellingen Nederland - Heemstede
    • Overijssel
      • Zwolle, Overijssel, Holland, 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.
  • Schweiz
    • Zürich (de)
      • Zurich, Zürich (de), Schweiz, 8008
        • Klinik Lengg AG
  • Slovenien
      • Maribor, Slovenien, 2000
        • University Clinical Centre Maribor
  • Tjekkiet
    • South Moravian
      • Brno, South Moravian, Tjekkiet, 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
  • Østrig
      • Salzburg, Østrig, 5020
        • Christian Doppler-Klinik - Universitätsklinikum der PMU
      • Sankt Pölten, Østrig, 3100
        • Universitätsklinikum St. Pölten
      • Vienna, Østrig, 1090
        • Medizinische Universitat Wien (Medical University of Vienna)
    • Upper Austria
      • Linz, Upper Austria, Østrig, 4020
        • Kepler Universitätsklinikum Linz - Med Campus III

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BHV-7000 25 mg Del A
Medicin: BHV-7000

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

Medicin: BHV-7000

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

Medicin: BHV-7000

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

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

Medicin: BHV-7000

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

Medicin: BHV-7000

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

Matching placebo taken once daily
Eksperimentel: BHV-7000 75 mg Del B
Medicin: BHV-7000

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

Medicin: BHV-7000

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

Medicin: BHV-7000

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

Matching placebo taken once daily

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biohaven Therapeutics Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. marts 2024

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

10. november 2023

Først indsendt, der opfyldte QC-kriterier

10. november 2023

Først opslået (Faktiske)

15. november 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BHV7000-302
  • 2023-508539-30 (Registry Identifier: EU CTR)
  • 2023 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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