Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
RISE 3
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
2 other identifiers
interventional
390
16 countries
152
Brief Summary
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2024
152 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2024
CompletedFirst Posted
Study publicly available on registry
March 13, 2024
CompletedStudy Start
First participant enrolled
May 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
July 1, 2026
June 1, 2026
2.4 years
March 8, 2024
June 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in 28-day average seizure frequency
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 Outcomes (5)
Percentage of Participants with at at least 50% reduction in seizure frequency per month
Baseline, Week 8 to Week 16
Change from Baseline 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
Baseline, Week 8 to Week 16
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Week 8 to Week 16
Number of Participants With Clinically Significant Laboratory Abnormalities
Week 8 to Week 16
Study Arms (3)
BHV-7000 50 mg
EXPERIMENTALBHV-7000 75 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male and Female participants 18 to 75 years of age at time of consent.
- 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
- 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.
- Ability to keep accurate seizure diaries
- Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total
You may not qualify if:
- 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.
- History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.
- Resection neurosurgery for seizures \<4 months prior to the screening visit.
- Radiosurgery performed \<2 years prior to the screening visit.
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (152)
Onyx Clinical Trials
Peoria, Arizona, 85381, United States
Xenoscience, Inc.
Phoenix, Arizona, 85004, United States
University of Arizona / Banner University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
ARENSIA Exploratory Medicine
Phoenix, Arizona, 85015, United States
Clinical Trials, Inc.
Little Rock, Arkansas, 72205, United States
Tri Valley Neurology Medical Associates, Inc.
Mission Hills, California, 91345, United States
Profound Research LLC
Poway, California, 92065, United States
UConn Health
Farmington, Connecticut, 06030, United States
Nova Clinical Research, LLC
Bradenton, Florida, 34209, United States
Las Mercedes Medical Research
Hialeah, Florida, 33012, United States
Coral Clinic Research
Homestead, Florida, 33032, United States
Y&L Advance Health Care, Inc d/b/a Elite Clinical Research
Miami, Florida, 33144, United States
Serenity Research Center
Miami, Florida, 33176, United States
Research Institute of Orlando
Orlando, Florida, 32806, United States
Comprehensive Neurology Clinic
Orlando, Florida, 32825, United States
Panhandle Research & Medical Clinic
Pensacola, Florida, 32502, United States
Knight Neurology
Rockledge, Florida, 32955, United States
Encore Medical Research of Weston LLC.
Weston, Florida, 33331, United States
Accelerated Clinical Trials, LLC
Peachtree Corners, Georgia, 30071, United States
Bluegrass Epilepsy Research
Lexington, Kentucky, 40504, United States
DelRicht Research
Baton Rouge, Louisiana, 70810, United States
Neurocare Of Louisiana
Covington, Louisiana, 70433, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
DelRicht Research
New Orleans, Louisiana, 70119, United States
LSU Health Shreveport
Shreveport, Louisiana, 71103, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Boston Neuro Research
South Dartmouth, Massachusetts, 02747, United States
SRI International
Plymouth, Michigan, 48170, United States
University of Missouri Health Care
Columbia, Missouri, 65212, United States
Somnos Clinical Research
Lincoln, Nebraska, 68510, United States
NEREG
Hackensack, New Jersey, 07601, United States
Tekton Research
Marlboro, New Jersey, 07746, United States
Dent Neurosciences Research Center
Amherst, New York, 14226, United States
Northwell Health
Great Neck, New York, 11021, United States
NYU Langone Health
New York, New York, 10016, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Premier Health
Dayton, Ohio, 45409, United States
Oregon Neurology Associates
Springfield, Oregon, 97477, United States
AHN
Pittsburgh, Pennsylvania, 15212, United States
MUSC
Charleston, South Carolina, 29425, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103, United States
Horizon Clinical Research Group
Cypress, Texas, 77429, United States
M3 Wake Research-Dallas
Dallas, Texas, 75246, United States
ANESC Research
El Paso, Texas, 79912, United States
UTHealth Houston
Houston, Texas, 77030, United States
UTHSC
Houston, Texas, 77030, United States
Stryde Research
Plano, Texas, 75093, United States
Intermountain Health
Murray, Utah, 84107, United States
Medstar Health Research Institute
McLean, Virginia, 22101, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029, Australia
St Vincents Hospital Melbourne - PPDS
Fitzroy, Victoria, 3065, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Flinders Medical Centre
Bedford Park, 5042, Australia
Odense Universitetshospital
Odense, Fyn, 5000, Denmark
Aarhus University Hospital
Aarhus, 8200, Denmark
Epilepsihospitalet Filadelfia
Dianalund, 4293, Denmark
Kuopion yliopistollinen sairaala
Kuopio, Northern Savonia, 70200, Finland
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, 33520, Finland
Helsinki University Hospital
Helsinki, Uusimaa, 00290, Finland
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Epilepsiezentrum Kork
Kehl, Baden-Wurttemberg, 77694, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
Epilepsieklinik Tabor
Bernau bei Berlin, Brandenburg, 16321, Germany
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
Marburg, Hesse, 35043, Germany
Klinikum Osnabrück GmbH
Osnabrück, Lower Saxony, 49076, Germany
Krankenhaus Mara gGmbH
Bielefeld, North Rhine-Westphalia, 33617, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103, Germany
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
Radeberg, Saxony, 01454, Germany
Vivantes - Humboldt Klinikum
Berlin, 13509, Germany
Universitätsklinikum Frankfurt
Frankfurt, 60590, Germany
Epilepsie-Zentrum Bodensee
Ravensburg, 88214, Germany
University General Hospital of Alexandroupolis
Alexandroupoli, 681 00, Greece
University General Hospital ''ATTIKON''
Chaïdári, 124 62, Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 546 36, Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, 546 36, Greece
Semmel Egyet Idegsebésze Neuro Klin
Budapest, 1145, Hungary
Nizam's Insti. of Medical Sciences
Hyderabad, 500082, India
Mallikatta Neuro Centre
Mangalore, 575002, India
Jaslok Hospital and Research
Mumbai, 400026, India
Dr G M Taori Memorial CIIMS
Nagpur, 440010, India
All India Institute of Medical Sciences (AIIMS)
New Delhi, 110029, India
Università degli Studi G. D'Annunzio Chieti-Pescara
Chieti, Abruzzo, 66013, Italy
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
Catanzaro, Calabria, 88100, Italy
AORN Antonio Cardarelli
Naples, Campania, 80131, Italy
AUSL di Bologna - Ospedale Bellaria
Bologna, Emilia-Romagna, 40123, Italy
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, 00133, Italy
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genoa, Liguria, 16147, Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardy, 20132, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, 20133, Italy
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
Milan, Lombardy, 20142, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Lombardy, 27100, Italy
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Baggiovara, Modena, 41126, Italy
IRCCS Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Molise, 86077, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Calambrone, Tuscany, 56018, Italy
Fondazione Policlinico Universitario A Gemelli-Rome
Roma, 00168, Italy
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Rome, 00165, Italy
Clinstile, S.A. de C.V.
Mexico City, 06700, Mexico
Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
Mexico City, 14050, Mexico
Accelerium, S. de R.L. de C.V. - PPDS
Monterrey, 64000, Mexico
Axis Heilsa S. de R.L. de C.V.
Obispado, 64060, Mexico
Neurociencias Estudios Clinicos S.C.
Sinaloa, 80020, Mexico
Clinical Research Institute SC-Mexico
Tlalnepantla, 54055, Mexico
FAICIC S De RL De CV
Veracruz, 91900, Mexico
MTZ Clinical Research
Krakow, 02-172, Poland
Pratia MCM Krakow
Krakow, 30-727, Poland
LANDA Specjalistyczne
Krakow, 31-156, Poland
Neurosphera SP. Z O.O
Warsaw, 02-829, Poland
Premium Clinic Wrocław
Wroclaw, 50-414, Poland
ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
Santa Maria da Feira, Aveiro District, 4520-211, Portugal
ULS de Matosinhos, EPE - Hospital Pedro Hispano
Senhora da Hora, Porto District, 4454-509, Portugal
Centro Clínico Académico, Braga - Hospital de Braga
Braga, 4710-243, Portugal
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, 1449-005, Portugal
Hospital da Luz Torres de Lisboa
Lisbon, 1600-209, Portugal
Emergency University Hospital
Bucharest, 11635, Romania
IN MEDIC, s.r.o.
Bardejov, 085 01, Slovakia
Kraskova 2636, Neurologické oddelenie
Rimavská Sobota, 979 01, Slovakia
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, 31008, Spain
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra, 36312, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035, Spain
Fundacio Assistencial Mutua de Terrassa
Barcelona, 08221, Spain
Hospital Universitario Clínico San Cecilio
Granada, 18007, Spain
Hospital Vithas Granada
Granada, 18008, Spain
Hospital Universitario Virgen de Las Nieves
Granada, 18013, Spain
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid, 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital blua sanitas valdebebas
Madrid, 28055, Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga, 29010, Spain
Centro de Neurologia Avanzada
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47003, Spain
Morriston Hospital
Swansea, Glamorgan, SA6 6NL, United Kingdom
Queen Elizabeth University Hospital-PPDS
Glasgow, Glasgow City, G51 4TF, United Kingdom
Salford Royal Hospital - PPDS
Salford, Manchester, M6 8HD, United Kingdom
The Walton Centre - PPDS
Liverpool, Merseyside, L9 7LJ, United Kingdom
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU, United Kingdom
University Hospital of Wales
Cardiff, South Glamorgan, CF14 4XW, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
St Georges NHS Foundation Trust
London, SW17 0QT, United Kingdom
The Royal London Hospital
London, WC1N 3HR, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2024
First Posted
March 13, 2024
Study Start
May 13, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
July 1, 2026
Record last verified: 2026-06