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一项确定 BHV-7000 对成人难治性局灶性癫痫是否有效且安全的研究 (RISE 2)

2026年9月28日 更新者：Biohaven Therapeutics Ltd.

一项 2/3 期多中心、随机、双盲、安慰剂对照研究，旨在评估 BHV-7000 对难治性局灶性癫痫受试者的疗效、安全性和耐受性

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

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

390

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：BHV-7000 25 毫克 A部分
药品：BHV-7000

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

药品：BHV-7000

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

药品：BHV-7000

BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
实验性的：BHV-7000 50 毫克 A 部分
药品：BHV-7000

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

药品：BHV-7000

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

药品：BHV-7000

BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
安慰剂比较：安慰剂A部分
药品：Placebo

Matching placebo taken once daily
实验性的：BHV-7000 75 毫克 B部分
药品：BHV-7000

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

药品：BHV-7000

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

药品：BHV-7000

BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily
安慰剂比较：安慰剂 B 部分
药品：Placebo

Matching placebo taken once daily

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Part B: Change from Baseline in 28-day average seizure frequency
大体时间：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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Biohaven Therapeutics Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年3月14日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2023年11月10日

首先提交符合 QC 标准的

2023年11月10日

首次发布 (实际的)

2023年11月15日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BHV7000-302
  • 2023-508539-30 (注册表标识符：EU CTR)
  • 2023 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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