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RECRUITING
NCT06309966
PHASE2/PHASE3

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

Sponsor: Biohaven Therapeutics Ltd.

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

390

Start Date

2024-05-13

Completion Date

2026-05

Last Updated

2026-04-09

Healthy Volunteers

No

Conditions

Interventions

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

DRUG

Placebo

Matching placebo taken once daily

Locations (173)

Accel Research

Birmingham, Alabama, United States

Onyx Clinical Trials

Peoria, Arizona, United States

Xenoscience, Inc.

Phoenix, Arizona, United States

University of Arizona / Banner University Medical Center Phoenix

Phoenix, Arizona, United States

ARENSIA Exploratory Medicine

Phoenix, Arizona, United States

Clinical Trials, Inc.

Little Rock, Arkansas, United States

Amicis Research Center

Lancaster, California, United States

Memorialcare Miller Children's & Women's Hospital Long Beach

Long Beach, California, United States

Tri Valley Neurology Medical Associates, Inc.

Mission Hills, California, United States

Stanford University

Palo Alto, California, United States

Profound Research LLC

Poway, California, United States

Kaiser Permanente

Aurora, Colorado, United States

UConn Health

Farmington, Connecticut, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

EZR Research, LLC

Boca Raton, Florida, United States

Nova Clinical Research, LLC

Bradenton, Florida, United States

Las Mercedes Medical Research

Hialeah, Florida, United States

Coral Clinic Research

Homestead, Florida, United States

Dm Healthworks

Kissimmee, Florida, United States

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

Miami, Florida, United States

Serenity Research Center

Miami, Florida, United States

Research Institute of Orlando

Orlando, Florida, United States

Comprehensive Neurology Clinic

Orlando, Florida, United States

Panhandle Research & Medical Clinic

Pensacola, Florida, United States

Knight Neurology

Rockledge, Florida, United States

PENS

Tampa, Florida, United States

Encore Medical Research of Weston LLC.

Weston, Florida, United States

Accelerated Clinical Trials, LLC

Peachtree Corners, Georgia, United States

Bluegrass Epilepsy Research

Lexington, Kentucky, United States

OLORMC

Baton Rouge, Louisiana, United States

DelRicht Research

Baton Rouge, Louisiana, United States

Neurocare Of Louisiana

Covington, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

DelRicht Research

New Orleans, Louisiana, United States

LSU Health Shreveport

Shreveport, Louisiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Boston Neuro Research

South Dartmouth, Massachusetts, United States

SRI International

Plymouth, Michigan, United States

University of Missouri Health Care

Columbia, Missouri, United States

Somnos Clinical Research

Lincoln, Nebraska, United States

NEREG

Hackensack, New Jersey, United States

Tekton Research

Marlboro, New Jersey, United States

Dent Neurosciences Research Center

Amherst, New York, United States

Northwell Health

Great Neck, New York, United States

Northwell Health Ped. Neurology

New Hyde Park, New York, United States

NYU Langone Health

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

UNC-Chapel Hill

Chapel Hill, North Carolina, United States

Cincinatti Children's Hospital

Cincinnati, Ohio, United States

Wright State University

Dayton, Ohio, United States

Oregon Neurology Associates

Springfield, Oregon, United States

AHN

Pittsburgh, Pennsylvania, United States

MUSC

Charleston, South Carolina, United States

WR-ClinSearch

Chattanooga, Tennessee, United States

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

Horizon Clinical Research Group

Cypress, Texas, United States

M3 Wake Research-Dallas

Dallas, Texas, United States

ANESC Research

El Paso, Texas, United States

Tarrant Neurology Associates

Fort Worth, Texas, United States

UTHealth Houston

Houston, Texas, United States

UTHSC

Houston, Texas, United States

Stryde Research

Plano, Texas, United States

Intermountain Health

Murray, Utah, United States

Medstar Health Research Institute

McLean, Virginia, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia

St Vincents Hospital Melbourne - PPDS

Fitzroy, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Flinders Medical Centre

Bedford Park, Australia

Odense Universitetshospital

Odense, Fyn, Denmark

Aarhus University Hospital

Aarhus, Denmark

Epilepsihospitalet Filadelfia

Dianalund, Denmark

Kuopion yliopistollinen sairaala

Kuopio, Northern Savonia, Finland

Tampereen yliopistollinen sairaala

Tampere, Pirkanmaa, Finland

Helsinki University Hospital

Helsinki, Uusimaa, Finland

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Epilepsiezentrum Kork

Kehl, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

LMU Klinikum der Universität München - Campus Großhadern

München, Bavaria, Germany

Epilepsieklinik Tabor

Bernau bei Berlin, Brandenburg, Germany

Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg

Marburg, Hesse, Germany

Klinikum Osnabrück GmbH

Osnabrück, Lower Saxony, Germany

Krankenhaus Mara gGmbH

Bielefeld, North Rhine-Westphalia, Germany

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh

Radeberg, Saxony, Germany

Vivantes - Humboldt Klinikum

Berlin, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Epilepsie-Zentrum Bodensee

Ravensburg, Germany

University General Hospital of Alexandroupolis

Alexandroupoli, Greece

University General Hospital ''ATTIKON''

Chaïdári, Greece

University General Hospital of Ioannina

Ioannina, Greece

AHEPA University General Hospital of Thessaloniki

Thessaloniki, Greece

Georgios Papanikolaou General Hospital of Thessaloniki

Thessaloniki, Greece

Semmel Egyet Idegsebésze Neuro Klin

Budapest, Hungary

Nizam's Insti. of Medical Sciences

Hyderabad, India

Mallikatta Neuro Centre

Mangalore, India

Jaslok Hospital and Research

Mumbai, India

Dr G M Taori Memorial CIIMS

Nagpur, India

All India Institute of Medical Sciences (AIIMS)

New Delhi, India

Università degli Studi G. D'Annunzio Chieti-Pescara

Chieti, Abruzzo, Italy

Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini

Catanzaro, Calabria, Italy

AORN Antonio Cardarelli

Naples, Campania, Italy

AUSL di Bologna - Ospedale Bellaria

Bologna, Emilia-Romagna, Italy

Fondazione PTV Policlinico Tor Vergata

Rome, Lazio, Italy

Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

Genoa, Liguria, Italy

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy

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

Milan, Lombardy, Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Lombardy, Italy

Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara

Baggiovara, Modena, Italy

IRCCS Istituto Neurologico Mediterraneo Neuromed

Pozzilli, Molise, Italy

Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

Ancona, The Marches, Italy

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

Calambrone, Tuscany, Italy

Fondazione Policlinico Universitario A Gemelli-Rome

Roma, Italy

IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

Rome, Italy

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Italy

Clinstile, S.A. de C.V.

Mexico City, Mexico

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

Mexico City, Mexico

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

Monterrey, Mexico

Axis Heilsa S. de R.L. de C.V.

Obispado, Mexico

Neurociencias Estudios Clinicos S.C.

Sinaloa, Mexico

Clinical Research Institute SC-Mexico

Tlalnepantla, Mexico

FAICIC S De RL De CV

Veracruz, Mexico

MTZ Clinical Research

Krakow, Poland

Pratia MCM Krakow

Krakow, Poland

LANDA Specjalistyczne

Krakow, Poland

Neurosphera SP. Z O.O

Warsaw, Poland

Premium Clinic Wrocław

Wroclaw, Poland

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

Santa Maria da Feira, Aveiro District, Portugal

ULS de Matosinhos, EPE - Hospital Pedro Hispano

Senhora da Hora, Porto District, Portugal

Centro Clínico Académico, Braga - Hospital de Braga

Braga, Portugal

ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra

Coimbra, Portugal

ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

Lisbon, Portugal

Hospital da Luz Torres de Lisboa

Lisbon, Portugal

Targu-Mures Emergency Clinical County Hospital - Str. Gh. Marinescu nr.50

Târgu Mureş, Mureș County, Romania

Emergency University Hospital

Bucharest, Romania

IN MEDIC, s.r.o.

Bardejov, Slovakia

Kraskova 2636, Neurologické oddelenie

Rimavská Sobota, Slovakia

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital del Mar

Barcelona, Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

Fundacio Assistencial Mutua de Terrassa

Barcelona, Spain

Hospital Universitario Clínico San Cecilio

Granada, Spain

Hospital Vithas Granada

Granada, Spain

Hospital Universitario Virgen de Las Nieves

Granada, Spain

Hospital Ruber Internacional (Grupo Quironsalud)

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Blua Sanitas Valdebebas Hospital

Madrid, Spain

Hospital blua sanitas valdebebas

Madrid, Spain

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Spain

Centro de Neurologia Avanzada

Seville, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Morriston Hospital

Swansea, Glamorgan, United Kingdom

Queen Elizabeth University Hospital-PPDS

Glasgow, Glasgow City, United Kingdom

Salford Royal Hospital - PPDS

Salford, Manchester, United Kingdom

The Walton Centre - PPDS

Liverpool, Merseyside, United Kingdom

John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom

University Hospital of Wales

Cardiff, South Glamorgan, United Kingdom

King's College Hospital

London, United Kingdom

St Georges NHS Foundation Trust

London, United Kingdom

The Royal London Hospital

London, United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom