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

April 16, 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

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 Contact

Study Locations

  • Australia
      • Bedford Park, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • Prince of Wales Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane & Women's Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • St Vincents Hospital Melbourne - PPDS
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • Royal Melbourne Hospital
  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
      • Dianalund, Denmark, 4293
        • Recruiting
        • Epilepsihospitalet Filadelfia
    • Fyn
      • Odense, Fyn, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital
  • Finland
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70200
        • Recruiting
        • Kuopion Yliopistollinen Sairaala
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Recruiting
        • Tampereen yliopistollinen sairaala
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Recruiting
        • Helsinki University Hospital
  • Germany
      • Berlin, Germany, 13509
        • Recruiting
        • Vivantes - Humboldt Klinikum
      • Frankfurt, Germany, 60590
        • Recruiting
        • Universitätsklinikum Frankfurt
      • Ravensburg, Germany, 88214
        • Recruiting
        • Epilepsie-Zentrum Bodensee
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Recruiting
        • Universitätsklinikum Freiburg
      • Kehl, Baden-Wurttemberg, Germany, 77694
        • Recruiting
        • Epilepsiezentrum Kork
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Recruiting
        • Universitätsklinikum Ulm
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Universitätsklinikum Erlangen
      • München, Bavaria, Germany, 81377
        • Recruiting
        • LMU Klinikum der Universität München - Campus Grosshadern
    • Brandenburg
      • Bernau bei Berlin, Brandenburg, Germany, 16321
        • Not yet recruiting
        • Epilepsieklinik Tabor
    • Hesse
      • Marburg, Hesse, Germany, 35043
        • Recruiting
        • Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
    • Lower Saxony
      • Osnabrück, Lower Saxony, Germany, 49076
        • Recruiting
        • Klinikum Osnabrück GmbH
    • North Rhine-Westphalia
      • Bielefeld, North Rhine-Westphalia, Germany, 33617
        • Recruiting
        • Krankenhaus Mara gGmbH
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Recruiting
        • Universitätsklinikum Bonn
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Not yet recruiting
        • Universitätsklinikum Münster
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Universitatsklinikum Leipzig
      • Radeberg, Saxony, Germany, 01454
        • Recruiting
        • Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
  • Greece
      • Alexandroupoli, Greece, 681 00
        • Recruiting
        • University General Hospital of Alexandroupolis
      • Chaïdári, Greece, 124 62
        • Recruiting
        • University General Hospital ''ATTIKON''
      • Ioannina, Greece, 455 00
        • Recruiting
        • University General Hospital of Ioannina
      • Thessaloniki, Greece, 546 36
        • Recruiting
        • AHEPA University General Hospital of Thessaloniki
      • Thessaloniki, Greece, 546 36
        • Recruiting
        • Georgios Papanikolaou General Hospital of Thessaloniki
  • Hungary
      • Budapest, Hungary, 1145
        • Recruiting
        • Semmel Egyet Idegsebésze Neuro Klin
  • India
      • Hyderabad, India, 500082
        • Recruiting
        • Nizam's Insti. of Medical Sciences
      • Mangalore, India, 575002
        • Recruiting
        • Mallikatta Neuro Centre
      • Mumbai, India, 400026
        • Recruiting
        • Jaslok Hospital and Research
      • Nagpur, India, 440010
        • Recruiting
        • Dr G M Taori Memorial CIIMS
      • New Delhi, India, 110029
        • Recruiting
        • All India Institute Of Medical Sciences (AIIMS)
  • Italy
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A Gemelli-Rome
      • Rome, Italy, 00165
        • Recruiting
        • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
      • Verona, Italy, 37126
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata di Verona
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66013
        • Recruiting
        • Università degli Studi G. D'Annunzio Chieti-Pescara
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • Recruiting
        • Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
    • Campania
      • Naples, Campania, Italy, 80131
        • Recruiting
        • AORN Antonio Cardarelli
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40123
        • Recruiting
        • AUSL di Bologna - Ospedale Bellaria
    • Lazio
      • Rome, Lazio, Italy, 00133
        • Recruiting
        • Fondazione PTV Policlinico Tor Vergata
    • Liguria
      • Genoa, Liguria, Italy, 16147
        • Recruiting
        • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele S.r.l. - PPDS
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
      • Milan, Lombardy, Italy, 20142
        • Recruiting
        • ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
      • Pavia, Lombardy, Italy, 27100
        • Recruiting
        • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
    • Modena
      • Baggiovara, Modena, Italy, 41126
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
    • Molise
      • Pozzilli, Molise, Italy, 86077
        • Recruiting
        • IRCCS Istituto Neurologico Mediterraneo Neuromed
    • The Marches
      • Ancona, The Marches, Italy, 60121
        • Recruiting
        • Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
    • Tuscany
      • Calambrone, Tuscany, Italy, 56018
        • Recruiting
        • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
  • Mexico
      • Mexico City, Mexico, 06700
        • Recruiting
        • Clinstile, S.A. de C.V.
      • Mexico City, Mexico, 14050
        • Not yet recruiting
        • Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
      • Monterrey, Mexico, 64000
        • Not yet recruiting
        • Accelerium, S. de R.L. de C.V. - PPDS
      • Obispado, Mexico, 64060
        • Recruiting
        • Axis Heilsa S. de R.L. de C.V.
      • Sinaloa, Mexico, 80020
        • Recruiting
        • Neurociencias Estudios Clinicos S.C.
      • Tlalnepantla, Mexico, 54055
        • Recruiting
        • Clinical Research Institute SC-Mexico
      • Veracruz, Mexico, 91900
        • Recruiting
        • FAICIC S De RL De CV
  • Poland
      • Krakow, Poland, 30-727
        • Recruiting
        • Pratia McM Krakow
      • Krakow, Poland, 31-156
        • Recruiting
        • LANDA Specjalistyczne
      • Krakow, Poland, 02-172
        • Recruiting
        • MTZ Clinical Research
      • Warsaw, Poland, 02-829
        • Recruiting
        • Neurosphera SP. Z O.O
      • Wroclaw, Poland, 50-414
        • Recruiting
        • Premium Clinic Wrocław
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • Centro Clínico Académico, Braga - Hospital de Braga
      • Coimbra, Portugal, 3000-459
        • Recruiting
        • ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
      • Lisbon, Portugal, 1600-209
        • Recruiting
        • Hospital da Luz Torres de Lisboa
      • Lisbon, Portugal, 1449-005
        • Recruiting
        • ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
    • Aveiro District
      • Santa Maria da Feira, Aveiro District, Portugal, 4520-211
        • Recruiting
        • ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
    • Porto District
      • Senhora da Hora, Porto District, Portugal, 4454-509
        • Recruiting
        • ULS de Matosinhos, EPE - Hospital Pedro Hispano
  • Romania
      • Bucharest, Romania, 11635
        • Recruiting
        • Emergency University Hospital
    • Mureș County
      • Târgu Mureş, Mureș County, Romania, 540136
        • Recruiting
        • Targu-Mures Emergency Clinical County Hospital - Str. Gh. Marinescu nr.50
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • Recruiting
        • IN MEDIC, s.r.o.
      • Rimavská Sobota, Slovakia, 979 01
        • Recruiting
        • Kraskova 2636, Neurologické oddelenie
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron - PPDS
      • Barcelona, Spain, 08221
        • Recruiting
        • Fundacio Assistencial Mutua de Terrassa
      • Granada, Spain, 18007
        • Recruiting
        • Hospital Universitario Clínico San Cecilio
      • Granada, Spain, 18013
        • Recruiting
        • Hospital Universitario Virgen De Las Nieves
      • Granada, Spain, 18008
        • Recruiting
        • Hospital Vithas Granada
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Ruber Internacional (Grupo Quironsalud)
      • Madrid, Spain, 28055
        • Not yet recruiting
        • Blua Sanitas Valdebebas Hospital
      • Madrid, Spain, 28055
        • Recruiting
        • Hospital Blua Sanitas Valdebebas
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga - Hospital General
      • Seville, Spain, 41013
        • Recruiting
        • Centro de Neurologia Avanzada
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe de Valencia
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clinico Universitario de Valladolid
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Universitario Germans Trias i Pujol
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitario de Bellvitge
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Recruiting
        • CHUVI - H.U. Alvaro Cunqueiro
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Not yet recruiting
        • Royal Free Hospital
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital
      • London, United Kingdom, SW17 0QT
        • Recruiting
        • St Georges NHS Foundation Trust
      • London, United Kingdom, WC1N 3HR
        • Recruiting
        • The Royal London Hospital
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Recruiting
        • Royal Victoria Infirmary
    • Glamorgan
      • Swansea, Glamorgan, United Kingdom, SA6 6NL
        • Recruiting
        • Morriston Hospital
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G51 4TF
        • Recruiting
        • Queen Elizabeth University Hospital-PPDS
    • Manchester
      • Salford, Manchester, United Kingdom, M6 8HD
        • Recruiting
        • Salford Royal Hospital - PPDS
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L9 7LJ
        • Recruiting
        • The Walton Centre - PPDS
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Recruiting
        • John Radcliffe Hospital
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF14 4XW
        • Recruiting
        • University Hospital of Wales
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Withdrawn
        • Accel Research
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • Onyx Clinical Trials
      • Phoenix, Arizona, United States, 85004
        • Recruiting
        • Xenoscience, Inc.
        • Contact:
      • Phoenix, Arizona, United States, 85015
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • University of Arizona / Banner University Medical Center Phoenix
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Clinical Trials, Inc.
    • California
      • Lancaster, California, United States, 93534
        • Withdrawn
        • Amicis Research Center
      • Long Beach, California, United States, 90806
        • Withdrawn
        • Memorialcare Miller Children's & Women's Hospital Long Beach
      • Mission Hills, California, United States, 91345
        • Recruiting
        • Tri Valley Neurology Medical Associates, Inc.
      • Palo Alto, California, United States, 94304
        • Withdrawn
        • Stanford University
      • Poway, California, United States, 92065
    • Colorado
      • Aurora, Colorado, United States, 80011
        • Withdrawn
        • Kaiser Permanente
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Recruiting
        • UConn Health
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Withdrawn
        • Children's National Medical Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Withdrawn
        • EZR Research, LLC
      • Bradenton, Florida, United States, 34209
        • Recruiting
        • Nova Clinical Research, LLC
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Las Mercedes Medical Research
      • Homestead, Florida, United States, 33032
        • Recruiting
        • Coral Clinic Research
      • Kissimmee, Florida, United States, 34741
        • Withdrawn
        • Dm Healthworks
      • Miami, Florida, United States, 33144
      • Miami, Florida, United States, 33176
      • Orlando, Florida, United States, 32806
      • Orlando, Florida, United States, 32825
        • Recruiting
        • Comprehensive Neurology Clinic
        • Contact:
      • Pensacola, Florida, United States, 32502
        • Recruiting
        • Panhandle Research & Medical Clinic
      • Rockledge, Florida, United States, 32955
      • Tampa, Florida, United States, 33609
        • Withdrawn
        • PENS
      • Weston, Florida, United States, 33331
        • Recruiting
        • Encore Medical Research of Weston LLC.
    • Georgia
      • Peachtree Corners, Georgia, United States, 30071
        • Recruiting
        • Accelerated Clinical Trials, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Recruiting
        • Bluegrass Epilepsy Research
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70810
        • Recruiting
        • DelRicht Research
        • Contact:
      • Baton Rouge, Louisiana, United States, 70808
        • Withdrawn
        • OLORMC
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Neurocare Of Louisiana
      • New Orleans, Louisiana, United States, 70112
      • New Orleans, Louisiana, United States, 70119
        • Recruiting
        • DelRicht Research
        • Contact:
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • LSU Health Shreveport
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
      • South Dartmouth, Massachusetts, United States, 02747
        • Recruiting
        • Boston Neuro Research
    • Michigan
      • Plymouth, Michigan, United States, 48170
        • Recruiting
        • SRI International
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri Health Care
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • NEREG
      • Marlboro, New Jersey, United States, 07746
        • Recruiting
        • Tekton Research
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurosciences Research Center
      • Great Neck, New York, United States, 11021
      • New Hyde Park, New York, United States, 11042
        • Withdrawn
        • Northwell Health Ped. Neurology
      • New York, New York, United States, 10016
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Withdrawn
        • UNC-Chapel Hill
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Withdrawn
        • Cincinatti Children's Hospital
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Premier Health
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Recruiting
        • Oregon Neurology Associates
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • MUSC
        • Contact:
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Withdrawn
        • WR-ClinSearch
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Le Bonheur Children's Hospital
        • Contact:
    • Texas
      • Cypress, Texas, United States, 77429
        • Recruiting
        • Horizon Clinical Research Group
      • Dallas, Texas, United States, 75246
        • Recruiting
        • M3 Wake Research-Dallas
      • El Paso, Texas, United States, 79912
        • Recruiting
        • ANESC Research
        • Contact:
      • Fort Worth, Texas, United States, 76104
        • Withdrawn
        • Tarrant Neurology Associates
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77030
        • Recruiting
        • UTHSC
      • Plano, Texas, United States, 75093
        • Recruiting
        • Stryde Research
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Health
        • Contact:
    • Virginia
      • McLean, Virginia, United States, 22101
        • Recruiting
        • Medstar Health Research Institute
        • Contact:

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 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 8-week double-blind treatment phase.
Baseline, Week 8 to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in 28-day average seizure frequency during first month of treatment
Time Frame: Baseline, Week 8 to Week 12
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
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 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 8 week double-blind phase to the observation phase.
Baseline, Week 8 to Week 16
Percentage of Participants with at at least 75% reduction in seizure frequency per month
Time Frame: Baseline, Week 8 to Week 16
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 16
Change from baseline in 7-day adjusted seizure frequency during first week of treatment
Time Frame: Baseline, Week 8 to Week 9
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 seziure frequency from observation phase over the first week of the double-blind phase.
Baseline, Week 8 to Week 9
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
Percentage of Participants with seizure freedom during DB Phase
Time Frame: Week 8 to Week 16
To compare the efficacy of BHV-7000 to placebo on seizure freedom (100% seizure reduction during the DBP phase). This objective will be measured by proportion of subjects that are seizure free during the double-blind phase.
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
Change from baseline in Patient Global Impression of Change (PGI-C)
Time Frame: Baseline, Week 16

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 8 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 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)

May 1, 2026

Study Completion (Estimated)

May 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)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 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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