Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy (RISE 3)

June 30, 2026 updated by: Biohaven Therapeutics Ltd.

A Phase 2/3 Multicenter, Randomization, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

390

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia, 5042
        • Flinders Medical Centre
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane & Women's Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincents Hospital Melbourne - PPDS
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital
      • Dianalund, Denmark, 4293
        • Epilepsihospitalet Filadelfia
    • Fyn
      • Odense, Fyn, Denmark, 5000
        • Odense Universitetshospital
  • Finland
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70200
        • Kuopion Yliopistollinen Sairaala
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Tampereen yliopistollinen sairaala
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Helsinki University Hospital
  • Germany
      • Berlin, Germany, 13509
        • Vivantes - Humboldt Klinikum
      • Frankfurt, Germany, 60590
        • Universitatsklinikum Frankfurt
      • Ravensburg, Germany, 88214
        • Epilepsie-Zentrum Bodensee
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Kehl, Baden-Wurttemberg, Germany, 77694
        • Epilepsiezentrum Kork
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Universitätsklinikum Ulm
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Universitätsklinikum Erlangen
    • Brandenburg
      • Bernau bei Berlin, Brandenburg, Germany, 16321
        • Epilepsieklinik Tabor
    • Hesse
      • Marburg, Hesse, Germany, 35043
        • Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
    • Lower Saxony
      • Osnabrück, Lower Saxony, Germany, 49076
        • Klinikum Osnabrück GmbH
    • North Rhine-Westphalia
      • Bielefeld, North Rhine-Westphalia, Germany, 33617
        • Krankenhaus Mara gGmbH
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Universitätsklinikum Bonn
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Universitätsklinikum Münster
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Universitätsklinikum Leipzig
      • Radeberg, Saxony, Germany, 01454
        • Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
  • Greece
      • Alexandroupoli, Greece, 681 00
        • University General Hospital of Alexandroupolis
      • Chaïdári, Greece, 124 62
        • University General Hospital ''ATTIKON''
      • Thessaloniki, Greece, 546 36
        • AHEPA University General Hospital of Thessaloniki
      • Thessaloniki, Greece, 546 36
        • Georgios Papanikolaou General Hospital of Thessaloniki
  • Hungary
      • Budapest, Hungary, 1145
        • Semmel Egyet Idegsebésze Neuro Klin
  • India
      • Hyderabad, India, 500082
        • Nizam's Insti. of Medical Sciences
      • Mangalore, India, 575002
        • Mallikatta Neuro Centre
      • Mumbai, India, 400026
        • Jaslok Hospital and Research
      • Nagpur, India, 440010
        • Dr G M Taori Memorial CIIMS
      • New Delhi, India, 110029
        • All India Institute Of Medical Sciences (AIIMS)
  • Italy
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario A Gemelli-Rome
      • Rome, Italy, 00165
        • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66013
        • Università degli Studi G. D'Annunzio Chieti-Pescara
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
    • Campania
      • Naples, Campania, Italy, 80131
        • AORN Antonio Cardarelli
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40123
        • AUSL di Bologna - Ospedale Bellaria
    • Lazio
      • Rome, Lazio, Italy, 00133
        • Fondazione PTV Policlinico Tor Vergata
    • Liguria
      • Genoa, Liguria, Italy, 16147
        • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Ospedale San Raffaele S.r.l. - PPDS
      • Milan, Lombardy, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
      • Milan, Lombardy, Italy, 20142
        • ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
      • Pavia, Lombardy, Italy, 27100
        • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
    • Modena
      • Baggiovara, Modena, Italy, 41126
        • Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
    • Molise
      • Pozzilli, Molise, Italy, 86077
        • IRCCS Istituto Neurologico Mediterraneo Neuromed
    • Tuscany
      • Calambrone, Tuscany, Italy, 56018
        • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
  • Mexico
      • Mexico City, Mexico, 06700
        • Clinstile, S.A. de C.V.
      • Mexico City, Mexico, 14050
        • Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
      • Monterrey, Mexico, 64000
        • Accelerium, S. de R.L. de C.V. - PPDS
      • Obispado, Mexico, 64060
        • Axis Heilsa S. de R.L. de C.V.
      • Sinaloa, Mexico, 80020
        • Neurociencias Estudios Clinicos S.C.
      • Tlalnepantla, Mexico, 54055
        • Clinical Research Institute SC-Mexico
      • Veracruz, Mexico, 91900
        • FAICIC S De RL De CV
  • Poland
      • Krakow, Poland, 30-727
        • Pratia MCM Krakow
      • Krakow, Poland, 02-172
        • MTZ Clinical Research
      • Krakow, Poland, 31-156
        • LANDA Specjalistyczne
      • Warsaw, Poland, 02-829
        • Neurosphera SP. Z O.O
      • Wroclaw, Poland, 50-414
        • Premium Clinic Wrocław
  • Portugal
      • Braga, Portugal, 4710-243
        • Centro Clínico Académico, Braga - Hospital de Braga
      • Lisbon, Portugal, 1449-005
        • ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
      • Lisbon, Portugal, 1600-209
        • Hospital da Luz Torres de Lisboa
    • Aveiro District
      • Santa Maria da Feira, Aveiro District, Portugal, 4520-211
        • ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
    • Porto District
      • Senhora da Hora, Porto District, Portugal, 4454-509
        • ULS de Matosinhos, EPE - Hospital Pedro Hispano
  • Romania
      • Bucharest, Romania, 11635
        • Emergency University Hospital
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • IN MEDIC, s.r.o.
      • Rimavská Sobota, Slovakia, 979 01
        • Kraskova 2636, Neurologické oddelenie
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron - PPDS
      • Barcelona, Spain, 08221
        • Fundacio Assistencial Mutua de Terrassa
      • Granada, Spain, 18007
        • Hospital Universitario Clínico San Cecilio
      • Granada, Spain, 18008
        • Hospital Vithas Granada
      • Granada, Spain, 18013
        • Hospital Universitario Virgen de las Nieves
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28034
        • Hospital Ruber Internacional (Grupo Quironsalud)
      • Madrid, Spain, 28055
        • Hospital blua sanitas valdebebas
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Malaga - Hospital General
      • Seville, Spain, 41013
        • Centro de Neurologia Avanzada
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
      • Valladolid, Spain, 47003
        • Hospital Clínico Universitario de Valladolid
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Hospital Universitario de Navarra
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • CHUVI - H.U. Alvaro Cunqueiro
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom, SW17 0QT
        • St Georges NHS Foundation Trust
      • London, United Kingdom, WC1N 3HR
        • The Royal London Hospital
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
    • Glamorgan
      • Swansea, Glamorgan, United Kingdom, SA6 6NL
        • Morriston Hospital
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital-PPDS
    • Manchester
      • Salford, Manchester, United Kingdom, M6 8HD
        • Salford Royal Hospital - PPDS
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L9 7LJ
        • The Walton Centre - PPDS
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF14 4XW
        • University Hospital of Wales
  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Onyx Clinical Trials
      • Phoenix, Arizona, United States, 85004
        • Xenoscience, Inc.
      • Phoenix, Arizona, United States, 85015
        • ARENSIA Exploratory Medicine
      • Phoenix, Arizona, United States, 85006
        • University of Arizona / Banner University Medical Center Phoenix
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Clinical Trials, Inc.
    • California
      • Mission Hills, California, United States, 91345
        • Tri Valley Neurology Medical Associates, Inc.
      • Poway, California, United States, 92065
        • Profound Research LLC
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • UConn Health
    • Florida
      • Bradenton, Florida, United States, 34209
        • Nova Clinical Research, LLC
      • Hialeah, Florida, United States, 33012
        • Las Mercedes Medical Research
      • Homestead, Florida, United States, 33032
        • Coral Clinic Research
      • Miami, Florida, United States, 33144
        • Y&L Advance Health Care, Inc d/b/a Elite Clinical Research
      • Miami, Florida, United States, 33176
        • Serenity Research Center
      • Orlando, Florida, United States, 32806
        • Research Institute of Orlando
      • Orlando, Florida, United States, 32825
        • Comprehensive Neurology Clinic
      • Pensacola, Florida, United States, 32502
        • Panhandle Research & Medical Clinic
      • Rockledge, Florida, United States, 32955
        • Knight Neurology
      • Weston, Florida, United States, 33331
        • Encore Medical Research of Weston LLC.
    • Georgia
      • Peachtree Corners, Georgia, United States, 30071
        • Accelerated Clinical Trials, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Bluegrass Epilepsy Research
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70810
        • Delricht Research
      • Covington, Louisiana, United States, 70433
        • Neurocare Of Louisiana
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
      • New Orleans, Louisiana, United States, 70119
        • Delricht Research
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Shreveport
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Boston Clinical Trials
      • South Dartmouth, Massachusetts, United States, 02747
        • Boston Neuro Research
    • Michigan
      • Plymouth, Michigan, United States, 48170
        • SRI International
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Health Care
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Somnos Clinical Research
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • NEREG
      • Marlboro, New Jersey, United States, 07746
        • Tekton Research
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurosciences Research Center
      • Great Neck, New York, United States, 11021
        • Northwell Health
      • New York, New York, United States, 10016
        • NYU Langone Health
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Ohio
      • Dayton, Ohio, United States, 45409
        • Premier Health
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Oregon Neurology Associates
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • AHN
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Le Bonheur Children's Hospital
    • Texas
      • Cypress, Texas, United States, 77429
        • Horizon Clinical Research Group
      • Dallas, Texas, United States, 75246
        • M3 Wake Research-Dallas
      • El Paso, Texas, United States, 79912
        • ANESC Research
      • Houston, Texas, United States, 77030
        • UTHealth Houston
      • Houston, Texas, United States, 77030
        • UTHSC
      • Plano, Texas, United States, 75093
        • Stryde Research
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Health
    • Virginia
      • McLean, Virginia, United States, 22101
        • Medstar Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 with clinically observable signs and/or symptoms 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Matching placebo taken once daily
Experimental: BHV-7000 50 mg
Drug: BHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
Drug: BHV-7000
BHV-7000 75 mg. Participants will take blinded investigational product (IP) once daily
Experimental: BHV-7000 75 mg
Drug: BHV-7000
BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily
Drug: BHV-7000
BHV-7000 75 mg. Participants will take blinded investigational product (IP) once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in 28-day average seizure frequency
Time Frame: Baseline, Week 8 to Week 16
To compare the efficacy of 75mg 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 8-week double-blind treatment phase.
Baseline, Week 8 to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Time Frame: Week 8 to Week 16
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 16
Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame: Week 8 to Week 16
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.
Week 8 to Week 16
Percentage of Participants with at at least 50% reduction in seizure frequency per month
Time Frame: Baseline, Week 8 to Week 16
To compare the efficacy 75mg 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 8 week double-blind phase to the observation phase.
Baseline, Week 8 to Week 16
Change from Baseline in 28-day average seizure frequency
Time Frame: Baseline, Week 8 to Week 16
To compare the efficacy of each of 50mg 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.
Baseline, Week 8 to Week 16
Percentage of Participants with at at least 50% reduction in seizure frequency per month
Time Frame: Baseline, Week 8 to Week 16
To compare the efficacy of 50mg 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 8 week double-blind phase to the observation phase.
Baseline, Week 8 to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biohaven Therapeutics Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHV7000-303
  • 2023-508811-21 (Registry Identifier: EU CTR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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