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ENROLLING BY INVITATION
NCT06443463
PHASE2

Long-term Safety and Tolerability of BHV-7000

Sponsor: Biohaven Therapeutics Ltd.

View on ClinicalTrials.gov

Summary

A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy

Official title: A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the 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

660

Start Date

2024-07-30

Completion Date

2027-01

Last Updated

2026-04-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

BHV-7000

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

DRUG

BHV-7000

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

Locations (283)

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

Barrow Neurological Institute

Phoenix, Arizona, United States

ARENSIA Exploratory Medicine

Phoenix, Arizona, United States

Center for Neurosciences

Tucson, Arizona, United States

Clinical Trials, Inc.

Little Rock, Arkansas, United States

WRN

Rogers, Arkansas, United States

University of California San Diego

La Jolla, California, United States

Amicis Research Center

Lancaster, California, United States

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

Long Beach, California, United States

University of California, Los Angeles

Los Angeles, California, United States

Tri Valley Neurology Medical Associates, Inc.

Mission Hills, California, United States

Stanford University

Palo Alto, California, United States

Profound Research LLC

Pasadena, California, United States

Profound Research LLC

Poway, California, United States

Kaiser Permanente

Aurora, Colorado, United States

University of Colorado Anschultz Medical Campus

Aurora, Colorado, United States

UConn Health

Farmington, Connecticut, United States

Yale School of Medicine - Yale-New Haven Hospital

New Haven, Connecticut, 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

University of Florida (Jacksonville)

Jacksonville, Florida, United States

Dm Healthworks

Kissimmee, Florida, United States

University of Miami

Miami, 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

Floridian Research Institute

Miami, Florida, United States

AdventHealth Orlando

Orlando, 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

Medsol Clinical Research Center

Port Charlotte, Florida, United States

Knight Neurology

Rockledge, Florida, United States

PENS

Tampa, Florida, United States

Santos Research Center

Tampa, Florida, United States

Encore Medical Research of Weston LLC.

Weston, Florida, United States

Pediatrix Medical Group of Florida

Winter Park, Florida, United States

Augusta University

Augusta, Georgia, United States

Accelerated Clinical Trials, LLC

Peachtree Corners, Georgia, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Consultants in Epilepsy & Neurology, PLLC

Boise, Idaho, United States

Northwestern University

Chicago, Illinois, United States

Revive Research Institute, Inc.

Elgin, Illinois, United States

McFarland Clinic

Ames, Iowa, United States

Bluegrass Epilepsy Research

Lexington, Kentucky, United States

OLOLRMC

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

John Hopkins University

Baltimore, Maryland, United States

Mid-Atlantic Epilepsy & Sleep Center, LLC

Bethesda, Maryland, United States

Javara

Silver Spring, Maryland, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Boston Neuro Research

South Dartmouth, Massachusetts, United States

SRI International

Plymouth, Michigan, United States

Revive Research Institute, Inc.

Rochester Hills, Michigan, United States

Minnesota Epilepsy Group, P.A.

Roseville, Minnesota, United States

University of Missouri Health Care

Columbia, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Somnos Clinical Research

Lincoln, Nebraska, United States

NEREG

Hackensack, New Jersey, United States

Inst of Neurology

Livingston, New Jersey, United States

Tekton Research

Marlboro, New Jersey, United States

Jersey Shore Medical Center

Neptune City, New Jersey, United States

Dent Neurosciences Research Center

Amherst, New York, United States

Northwell Health

Great Neck, New York, United States

BCHP

Hawthorne, New York, United States

Northwell Health

New Hyde Park, New York, United States

NYU Langone Health

New York, New York, United States

NYU

New York, New York, United States

Stony Brook Medicine

Stony Brook, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Five Towns Neuroscience Research

Woodmere, New York, United States

UNC-Chapel Hill

Chapel Hill, North Carolina, United States

OnSite Clinical Solutions

Charlotte, North Carolina, United States

Accellacare

Mooresville, North Carolina, United States

Wake Forest Baptist

Winston-Salem, North Carolina, United States

NeuroScience Research Center

Canton, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

OSU

Columbus, Ohio, United States

Wright State University

Dayton, Ohio, United States

Oregon Neurology Associates

Springfield, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

AHN

Pittsburgh, Pennsylvania, United States

UPMC

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

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Horizon Clinical Research Group

Cypress, Texas, United States

Clinical Research Solutions LLC

Cypress, Texas, United States

Neurology Consultants of Dallas, PA

Dallas, Texas, United States

M3 Wake Research-Dallas

Dallas, Texas, United States

ANESC Research

El Paso, Texas, United States

Tarrant Neurology Consultants

Fort Worth, Texas, United States

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

UTHealth Houston

Houston, Texas, United States

UTHSC

Houston, Texas, United States

Stryde Research

Plano, Texas, United States

UT Health San Antonio

San Antonio, Texas, United States

Road Runner Research, Ltd

San Antonio, Texas, United States

Intermountain Health

Murray, Utah, United States

University of Utah

Salt Lake City, Utah, United States

UVM MC

Burlington, Vermont, United States

University of Virginia

Charlottesville, Virginia, United States

Medstar Health Research Institute

McLean, Virginia, United States

Henrico Doctors Neurology Associates, LLC

Richmond, Virginia, United States

Carilion Clinic

Roanoke, Virginia, United States

STAT Research S.A.

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital General de Agudos Dr. José María Ramos Mejia

Balvanera, Ciudad Autónoma de BuenosAires, Argentina

Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Hospital Británico de Buenos Aires

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Investigaciones Sanatorio Del Sur

San Miguel de Tucumán, Tucumán Province, Argentina

Sanatorio de la Trinidad - Mitre

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI

Buenos Aires, Argentina

Instituto Privado Kremer

Córdoba, Argentina

Conci Carpinella - Santa Rosa N° 748

Córdoba, Argentina

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

Kepler Universitätsklinikum Linz - Med Campus III

Linz, Upper Austria, Austria

Christian Doppler-Klinik - Universitätsklinikum der PMU

Salzburg, Austria

Universitätsklinikum St. Pölten

Sankt Pölten, Austria

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, Austria

UZ Antwerpen

Edegem, Antwerpen, Belgium

Hôpital Erasme

Anderlecht, Brussels Capital, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

CHU UCL Namur - Site Godinne

Yvoir, Namur, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

Centro de especialidades médicas Vanguardia

Temuco, Región de la Araucanía, Chile

Instituto Neurologico Thalamus

Viña del Mar, Región de Valparaíso, Chile

Hospital Padre Hurtado

Santiago, Región-MetropolitanadeSantiago, Chile

BIOCINETIC Ltda

Santiago, Región-MetropolitanadeSantiago, Chile

Centro de Investigacion Clinica UC

Santiago, Región-MetropolitanadeSantiago, Chile

Clinical Hospital Dubrava

Zagreb, City of Zagreb, Croatia

Clinical Hospital Sveti duh

Zagreb, City of Zagreb, Croatia

Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29

Zagreb, City of Zagreb, Croatia

Klinicki bolnicki centar Zagreb

Zagreb, City of Zagreb, Croatia

Clinical Hospital Center Rijeka - PPDS

Rijeka, Croatia

Fakultni nemocnice v Motole

Prague, Praha, Hlavní Mesto, Czechia

Fakultni nemocnice u sv. Anny v Brne

Brno, South Moravian, Czechia

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

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, Bas-Rhin, France

CHU Dijon Bourgogne

Dijon, Côte-d'Or, France

CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan

Toulouse, Haute-Garonne, France

CHU de Montpellier- Hôpital Gui De Chauliac

Montpellier, Hérault, France

CHRU de Tours - Hôpital Bretonneau

Tours, Indre-et-Loire, France

CHRU Nancy

Nancy, Meurthe-et-Moselle, France

CHU de Lille - Hopital Claude Huriez

Lille, Nord, France

Hospices Civils de Lyon - 59 Bd Pinel

Lyon, Rhône, France

Hôpital Pontchaillou

Rennes, France

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

Pécsi Tudományegyetem Klinikai Kozpont -Ret u.

Pécs, Baranya, Hungary

Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus

Debrecen, Hajdú-Bihar, Hungary

Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, Hungary

SE INK Juhasz Pal Epilepszia Központ

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

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

Mexico City, Mexico

Clinstile, S.A. de C.V.

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

Kempenhaeghe - PPDS

Heeze, North Brabant, Netherlands

Stichting Epilepsie Instellingen Nederland - Heemstede

Heemstede, North Holland, Netherlands

Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20

Zwolle, Overijssel, Netherlands

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

Poznan, Greater Poland Voivodeship, Poland

Przychodnia VISTAMED

Wroclaw, Lower Silesian Voivodeship, Poland

Clinical Best Solutions - Lublin

Lublin, Lublin Voivodeship, Poland

NZOZ IGNIS dr med. Alicja Lobinska

Świdnik, Lublin Voivodeship, Poland

Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o

Nowa Sól, Lubusz Voivodeship, Poland

Santa Familia PTG Lodz

Lodz, Lódzkie, Poland

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship, Poland

Neurosphera SP. Z O.O

Warsaw, Masovian Voivodeship, Poland

Instytut Psychiatrii i Neurologii

Warsaw, Masovian Voivodeship, Poland

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, Poland

Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6

Gdansk, Poland

Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44

Katowice, Poland

Pratia MCM Kraków

Krakow, Poland

LANDA Specjalistyczne Gabinety Lekarskie

Krakow, 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

University Clinical Centre Maribor

Maribor, Slovenia

InnoMed Clinical Trial Centre

Cape Town, Western Cape, South Africa

Groote Schuur Hospital

Cape Town, Western Cape, South Africa

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

Klinik Lengg AG

Zurich, Zürich (de), Switzerland

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