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En studie för att avgöra om BHV-7000 är effektiv och säker hos vuxna med refraktär fokal epilepsi (RISE 2)

28 september 2026 uppdaterad av: Biohaven Therapeutics Ltd.

En fas 2/3 multicenterstudie, randomiserad, dubbelblind, placebokontrollerad, studie för att utvärdera effektiviteten, säkerheten och tolerabiliteten av BHV-7000 hos patienter med refraktär fokal epilepsi

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

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

390

Fas

  • Fas 2
  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • 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
  • Förenta staterna
    • Arizona
      • Phoenix, Arizona, Förenta staterna, 85013
        • Barrow Neurological Institute
      • Tucson, Arizona, Förenta staterna, 85718
        • Center for Neurosciences
    • Arkansas
      • Little Rock, Arkansas, Förenta staterna, 72205
        • Clinical Trials, Inc.
    • California
      • La Jolla, California, Förenta staterna, 92041
        • University of California San Diego
      • Los Angeles, California, Förenta staterna, 90095
        • University of California, Los Angeles
      • Palo Alto, California, Förenta staterna, 94304
        • Stanford Health Care
      • Pasadena, California, Förenta staterna, 91105
        • Profound Research LLC
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80045
        • University of Colorado Anschultz Medical Campus
    • Connecticut
      • New Haven, Connecticut, Förenta staterna, 06519
        • Yale School of Medicine - Yale-New Haven Hospital
    • Florida
      • Boca Raton, Florida, Förenta staterna, 33486
        • EZR Research LLC
      • Bradenton, Florida, Förenta staterna, 34209
        • Nova Clinical Research, LLC
      • Jacksonville, Florida, Förenta staterna, 32209
        • University of Florida (Jacksonville)
      • Miami, Florida, Förenta staterna, 33136
        • University of Miami
      • Port Charlotte, Florida, Förenta staterna, 33952
        • Medsol Clinical Research Center
      • Tampa, Florida, Förenta staterna, 33615
        • Santos Research Center
      • Weston, Florida, Förenta staterna, 33331
        • Encore Medical Research of Weston LLC.
    • Georgia
      • Augusta, Georgia, Förenta staterna, 30912
        • Augusta University
    • Hawaii
      • Honolulu, Hawaii, Förenta staterna, 96817
        • Hawaii Pacific Neuroscience
    • Idaho
      • Boise, Idaho, Förenta staterna, 83702
        • Consultants in Epilepsy & Neurology, PLLC
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
        • Northwestern University
      • Elgin, Illinois, Förenta staterna, 60123
        • Revive Research Institute, Inc.
    • Kentucky
      • Lexington, Kentucky, Förenta staterna, 40504
        • Bluegrass Epilepsy Research
    • Maryland
      • Bethesda, Maryland, Förenta staterna, 20817
        • MAESC
      • Silver Spring, Maryland, Förenta staterna, 20901
        • Javara
    • Minnesota
      • Roseville, Minnesota, Förenta staterna, 55113
        • Minnesota Epilepsy Group, P.A.
    • Missouri
      • St Louis, Missouri, Förenta staterna, 63110
        • Washington University School of Medicine
    • New Jersey
      • Hackensack, New Jersey, Förenta staterna, 07601
        • NEREG
      • Livingston, New Jersey, Förenta staterna, 07039
        • Inst of Neurology
    • New York
      • Amherst, New York, Förenta staterna, 14226
        • Dent Neurosciences Research Center
      • Hawthorne, New York, Förenta staterna, 10532
        • BCHP
      • New York, New York, Förenta staterna, 10021
        • Northwell Health
      • Stony Brook, New York, Förenta staterna, 11794
        • Stony Brook Medicine
      • Woodmere, New York, Förenta staterna, 11598
        • Five Towns Neuroscience Research
    • North Carolina
      • Winston-Salem, North Carolina, Förenta staterna, 27157
        • Wake Forest Baptist
    • Ohio
      • Canton, Ohio, Förenta staterna, 44718
        • NeuroScience Research Center
      • Cincinnati, Ohio, Förenta staterna, 45267
        • University of Cincinnati
      • Columbus, Ohio, Förenta staterna, 43214
        • OSU
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, Förenta staterna, 15213
        • UPMC
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, Förenta staterna, 75243
        • Neurology Consultants of Dallas, PA
      • Fort Worth, Texas, Förenta staterna, 76104
        • Tarrant Neurology Consultants
      • San Antonio, Texas, Förenta staterna, 78229
        • UT Health San Antonio
      • San Antonio, Texas, Förenta staterna, 78249
        • Road Runner Research, Ltd
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84132
        • University of Utah
    • Virginia
      • Charlottesville, Virginia, Förenta staterna, 22903
        • University of Virginia
      • Richmond, Virginia, Förenta staterna, 23235
        • Henrico Doctors Neurology Associates, LLC
      • Roanoke, Virginia, Förenta staterna, 24011
        • Carilion Clinic
  • Nederländerna
    • North Brabant
      • Heeze, North Brabant, Nederländerna, 5591 VE
        • Kempenhaeghe - PPDS
    • North Holland
      • Heemstede, North Holland, Nederländerna, 2103 SW
        • Stichting Epilepsie Instellingen Nederland - Heemstede
    • Overijssel
      • Zwolle, Overijssel, Nederländerna, 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
  • Tjeckien
    • South Moravian
      • Brno, South Moravian, Tjeckien, 602 00
        • Fakultni nemocnice u sv. Anny v Brne
  • Ungern
      • Budapest, Ungern, 1145
        • SE INK Juhasz Pal Epilepszia Központ
      • Budapest, Ungern, 1106
        • Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
    • Baranya
      • Pécs, Baranya, Ungern, 7623
        • Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Ungern, 4031
        • Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus
  • Österrike
      • Salzburg, Österrike, 5020
        • Christian Doppler-Klinik - Universitätsklinikum der PMU
      • Sankt Pölten, Österrike, 3100
        • Universitätsklinikum St. Pölten
      • Vienna, Österrike, 1090
        • Medizinische Universitat Wien (Medical University of Vienna)
    • Upper Austria
      • Linz, Upper Austria, Österrike, 4020
        • Kepler Universitätsklinikum Linz - Med Campus III

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: BHV-7000 25 mg del A
Läkemedel: BHV-7000

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

Läkemedel: BHV-7000

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

Läkemedel: BHV-7000

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

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

Läkemedel: BHV-7000

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

Läkemedel: BHV-7000

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

Matching placebo taken once daily
Experimentell: BHV-7000 75 mg Del B
Läkemedel: BHV-7000

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

Läkemedel: BHV-7000

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

Läkemedel: BHV-7000

BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
Placebo-jämförare: Placebo Del B
Läkemedel: Placebo

Matching placebo taken once daily

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Part B: Change from Baseline in 28-day average seizure frequency
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Biohaven Therapeutics Ltd.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

14 mars 2024

Primärt slutförande (Beräknad)

1 december 2026

Avslutad studie (Beräknad)

1 december 2026

Studieregistreringsdatum

Först inskickad

10 november 2023

Först inskickad som uppfyllde QC-kriterierna

10 november 2023

Första postat (Faktisk)

15 november 2023

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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