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Focal EpilepsyPhase 2/3RISE 3NCT06309966

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

A Phase 2/3 study testing BHV-7000 in people with Focal Epilepsy, run by Biohaven Therapeutics Ltd. at 150 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Focal Epilepsy
What is being tested?
BHV-7000
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
390 participants
Where
150 sitesin 16 countries
Study dates
13 May 2024to Oct 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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

Who cannot join

  • 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

Trial locations and contacts

150 sites in 16 countries.

150 sites in 16 countries

United States50 sites

  • Dent Neurosciences Research Center

    Amherst, New York, 14226

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • DelRicht Research

    Baton Rouge, Louisiana, 70810

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Nova Clinical Research, LLC

    Bradenton, Florida, 34209

  • MUSC

    Charleston, South Carolina, 29425

  • University of Missouri Health Care

    Columbia, Missouri, 65212

  • Neurocare Of Louisiana

    Covington, Louisiana, 70433

  • Horizon Clinical Research Group

    Cypress, Texas, 77429

  • M3 Wake Research-Dallas

    Dallas, Texas, 75246

  • Premier Health

    Dayton, Ohio, 45409

  • ANESC Research

    El Paso, Texas, 79912

  • UConn Health

    Farmington, Connecticut, 06030

  • Northwell Health

    Great Neck, New York, 11021

  • NEREG

    Hackensack, New Jersey, 07601

  • Las Mercedes Medical Research

    Hialeah, Florida, 33012

  • Coral Clinic Research

    Homestead, Florida, 33032

  • UTHealth Houston

    Houston, Texas, 77030

  • UTHSC

    Houston, Texas, 77030

  • Bluegrass Epilepsy Research

    Lexington, Kentucky, 40504

  • Somnos Clinical Research

    Lincoln, Nebraska, 68510

  • Clinical Trials, Inc.

    Little Rock, Arkansas, 72205

  • Tekton Research

    Marlboro, New Jersey, 07746

  • Medstar Health Research Institute

    McLean, Virginia, 22101

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38103

  • Y&L Advance Health Care, Inc d/b/a Elite Clinical Research

    Miami, Florida, 33144

  • Serenity Research Center

    Miami, Florida, 33176

  • Tri Valley Neurology Medical Associates, Inc.

    Mission Hills, California, 91345

  • Intermountain Health

    Murray, Utah, 84107

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • DelRicht Research

    New Orleans, Louisiana, 70119

  • NYU Langone Health

    New York, New York, 10016

  • Research Institute of Orlando

    Orlando, Florida, 32806

  • Comprehensive Neurology Clinic

    Orlando, Florida, 32825

  • Accelerated Clinical Trials, LLC

    Peachtree Corners, Georgia, 30071

  • Panhandle Research & Medical Clinic

    Pensacola, Florida, 32502

  • Onyx Clinical Trials

    Peoria, Arizona, 85381

  • Xenoscience, Inc.

    Phoenix, Arizona, 85004

  • University of Arizona / Banner University Medical Center Phoenix

    Phoenix, Arizona, 85006

  • ARENSIA Exploratory Medicine

    Phoenix, Arizona, 85015

  • AHN

    Pittsburgh, Pennsylvania, 15212

  • Stryde Research

    Plano, Texas, 75093

  • SRI International

    Plymouth, Michigan, 48170

  • Profound Research LLC

    Poway, California, 92065

  • Knight Neurology

    Rockledge, Florida, 32955

  • LSU Health Shreveport

    Shreveport, Louisiana, 71103

  • Boston Neuro Research

    South Dartmouth, Massachusetts, 02747

  • Oregon Neurology Associates

    Springfield, Oregon, 97477

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Encore Medical Research of Weston LLC.

    Weston, Florida, 33331

Other trials in United States

Spain17 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035

  • Fundacio Assistencial Mutua de Terrassa

    Barcelona, 08221

  • Hospital Universitario Clínico San Cecilio

    Granada, 18007

  • Hospital Vithas Granada

    Granada, 18008

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18013

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Ruber Internacional (Grupo Quironsalud)

    Madrid, 28034

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital blua sanitas valdebebas

    Madrid, 28055

  • Hospital Regional Universitario de Malaga - Hospital General

    Málaga, 29010

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008

  • Centro de Neurologia Avanzada

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003

  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, Pontevedra, 36312

Other trials in Spain

Germany15 sites

  • Vivantes - Humboldt Klinikum

    Berlin, 13509

  • Epilepsieklinik Tabor

    Bernau bei Berlin, Brandenburg, 16321

  • Krankenhaus Mara gGmbH

    Bielefeld, North Rhine-Westphalia, 33617

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127

  • Universitätsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Epilepsiezentrum Kork

    Kehl, Baden-Wurttemberg, 77694

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg

    Marburg, Hesse, 35043

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

  • Klinikum Osnabrück GmbH

    Osnabrück, Lower Saxony, 49076

  • Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh

    Radeberg, Saxony, 01454

  • Epilepsie-Zentrum Bodensee

    Ravensburg, 88214

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Italy15 sites

  • Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara

    Baggiovara, Modena, 41126

  • AUSL di Bologna - Ospedale Bellaria

    Bologna, Emilia-Romagna, 40123

  • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

    Calambrone, Tuscany, 56018

  • Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini

    Catanzaro, Calabria, 88100

  • Università degli Studi G. D'Annunzio Chieti-Pescara

    Chieti, Abruzzo, 66013

  • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

    Genoa, Liguria, 16147

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, Lombardy, 20132

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, Lombardy, 20133

  • ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo

    Milan, Lombardy, 20142

  • AORN Antonio Cardarelli

    Naples, Campania, 80131

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

    Pavia, Lombardy, 27100

  • IRCCS Istituto Neurologico Mediterraneo Neuromed

    Pozzilli, Molise, 86077

  • Fondazione Policlinico Universitario A Gemelli-Rome

    Roma, 00168

  • Fondazione PTV Policlinico Tor Vergata

    Rome, Lazio, 00133

  • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

    Rome, 00165

Other trials in Italy

United Kingdom9 sites

  • University Hospital of Wales

    Cardiff, South Glamorgan, CF14 4XW

  • Queen Elizabeth University Hospital-PPDS

    Glasgow, Glasgow City, G51 4TF

  • King's College Hospital

    London, SE5 9RS

  • St Georges NHS Foundation Trust

    London, SW17 0QT

  • The Royal London Hospital

    London, WC1N 3HR

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • John Radcliffe Hospital

    Oxford, Oxfordshire, OX3 9DU

  • Salford Royal Hospital - PPDS

    Salford, Manchester, M6 8HD

  • Morriston Hospital

    Swansea, Glamorgan, SA6 6NL

Other trials in United Kingdom

Australia8 sites

  • Flinders Medical Centre

    Bedford Park, 5042

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • St Vincents Hospital Melbourne - PPDS

    Fitzroy, Victoria, 3065

  • Austin Health

    Heidelberg, Victoria, 3084

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

Other trials in Australia

Mexico7 sites

  • Clinstile, S.A. de C.V.

    Mexico City, 06700

  • Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city

    Mexico City, 14050

  • Accelerium, S. de R.L. de C.V. - PPDS

    Monterrey, 64000

  • Axis Heilsa S. de R.L. de C.V.

    Obispado, 64060

  • Neurociencias Estudios Clinicos S.C.

    Sinaloa, 80020

  • Clinical Research Institute SC-Mexico

    Tlalnepantla, 54055

  • FAICIC S De RL De CV

    Veracruz, 91900

Other trials in Mexico

India5 sites

  • Nizam's Insti. of Medical Sciences

    Hyderabad, 500082

  • Mallikatta Neuro Centre

    Mangalore, 575002

  • Jaslok Hospital and Research

    Mumbai, 400026

  • Dr G M Taori Memorial CIIMS

    Nagpur, 440010

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi, 110029

Other trials in India

Poland5 sites

  • MTZ Clinical Research

    Krakow, 02-172

  • Pratia MCM Krakow

    Krakow, 30-727

  • LANDA Specjalistyczne

    Krakow, 31-156

  • Neurosphera SP. Z O.O

    Warsaw, 02-829

  • Premium Clinic Wrocław

    Wroclaw, 50-414

Other trials in Poland

Portugal5 sites

  • Centro Clínico Académico, Braga - Hospital de Braga

    Braga, 4710-243

  • ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

    Lisbon, 1449-005

  • Hospital da Luz Torres de Lisboa

    Lisbon, 1600-209

  • ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião

    Santa Maria da Feira, Aveiro District, 4520-211

  • ULS de Matosinhos, EPE - Hospital Pedro Hispano

    Senhora da Hora, Porto District, 4454-509

Other trials in Portugal

Greece4 sites

  • University General Hospital of Alexandroupolis

    Alexandroupoli, 681 00

  • University General Hospital ''ATTIKON''

    Chaïdári, 124 62

  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki, 546 36

  • Georgios Papanikolaou General Hospital of Thessaloniki

    Thessaloniki, 546 36

Other trials in Greece

Denmark3 sites

  • Aarhus University Hospital

    Aarhus, 8200

  • Epilepsihospitalet Filadelfia

    Dianalund, 4293

  • Odense Universitetshospital

    Odense, Fyn, 5000

Other trials in Denmark

Finland3 sites

  • Helsinki University Hospital

    Helsinki, Uusimaa, 00290

  • Kuopion yliopistollinen sairaala

    Kuopio, Northern Savonia, 70200

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa, 33520

Other trials in Finland

Slovakia2 sites

  • IN MEDIC, s.r.o.

    Bardejov, 085 01

  • Kraskova 2636, Neurologické oddelenie

    Rimavská Sobota, 979 01

Other trials in Slovakia

Hungary1 site

  • Semmel Egyet Idegsebésze Neuro Klin

    Budapest, 1145

Other trials in Hungary

Romania1 site

  • Emergency University Hospital

    Bucharest, 11635

Other trials in Romania

About this study

Official title: 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.

Conditions
Focal Epilepsy
Being tested
BHV-7000, Placebo
Keywords
Focal Epilepsy, Epilepsy, Seizure, Refractory Epilepsy, Partial Epilepsy
Medical subject headings
Epilepsies, Partial, Epilepsy, Seizures, Drug Resistant Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BHV-7000Drug

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

  • BHV-7000Drug

    BHV-7000 75 mg. Participants will take blinded investigational product (IP) once daily

  • PlaceboDrug

    Matching placebo taken once daily

Study groups in NCT06309966
Study groupRoleWhat they receive
BHV-7000 50 mgExperimentalNot described
Receives: Drug: BHV-7000
BHV-7000 75 mgExperimentalNot described
Receives: Drug: BHV-7000
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 8 to Week 16

Secondary outcomes (5)

  1. Percentage of Participants with at at least 50% reduction in seizure frequency per month

    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.

    Measured: Baseline, Week 8 to Week 16

  2. Change from Baseline in 28-day average seizure frequency

    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.

    Measured: Baseline, Week 8 to Week 16

  3. Percentage of Participants with at at least 50% reduction in seizure frequency per month

    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.

    Measured: Baseline, Week 8 to Week 16

  4. Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs

    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.

    Measured: Week 8 to Week 16

  5. Number of Participants With Clinically Significant Laboratory Abnormalities

    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.

    Measured: Week 8 to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start13 May 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
390 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06309966
Sponsor's protocol ID
BHV7000-303
Other IDs
2023-508811-21, 2023
Acronym
RISE 3
Status last verified
Aug 2026
First submitted
8 Mar 2024
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BHV-7000 in people with Focal Epilepsy, run by Biohaven Therapeutics Ltd. at 150 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, Spain, Germany, Italy, United Kingdom and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in 28-day average seizure frequency (time frame: Baseline, Week 8 to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06309966.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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