AzTrials
AzTrials

Focal EpilepsyPhase 2NCT06443463

Long-term Safety and Tolerability of BHV-7000

A Phase 2 study testing BHV-7000 in people with Focal Epilepsy, run by Biohaven Therapeutics Ltd. at 283 sites in 27 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

Search all trials

Trial summary

A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset 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?
No, everyone receives an active treatment
How many people
660 participants
Where
283 sitesin 27 countries
Study dates
30 Jul 2024to Jan 2027
Phase
Phase 2

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

  • Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303.
  • (FOCBP) Females of Child Bearing Potential must have a negative urine pregnancy test at the Baseline/Day 0 visit

Who cannot join

  • Any condition, such as an ongoing AE with/without sequelae, or is poorly tolerating IP in the double-blind phase of the parent study, 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.
  • Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures

Trial locations and contacts

283 sites in 27 countries. Contact the study team or a site near you to ask about taking part.

283 sites in 27 countries

United States115 sites
  • McFarland Clinic

    Ames, Iowa, 50010

  • Dent Neurosciences Research Center

    Amherst, New York, 14226

  • Augusta University

    Augusta, Georgia, 30912

  • Kaiser Permanente

    Aurora, Colorado, 80011

  • University of Colorado Anschultz Medical Campus

    Aurora, Colorado, 80045

  • John Hopkins University

    Baltimore, Maryland, 21287

  • OLOLRMC

    Baton Rouge, Louisiana, 70808

  • DelRicht Research

    Baton Rouge, Louisiana, 70810

  • Mid-Atlantic Epilepsy & Sleep Center, LLC

    Bethesda, Maryland, 20817

  • Accel Research

    Birmingham, Alabama, 35244

  • EZR Research LLC

    Boca Raton, Florida, 33486

  • Consultants in Epilepsy & Neurology, PLLC

    Boise, Idaho, 83702

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Nova Clinical Research, LLC

    Bradenton, Florida, 34209

  • UVM MC

    Burlington, Vermont, 05401

  • NeuroScience Research Center

    Canton, Ohio, 44718

  • UNC-Chapel Hill

    Chapel Hill, North Carolina, 27514

  • MUSC

    Charleston, South Carolina, 29425

  • OnSite Clinical Solutions

    Charlotte, North Carolina, 28211

  • University of Virginia

    Charlottesville, Virginia, 22903

  • WR-ClinSearch

    Chattanooga, Tennessee, 37421

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University of Missouri Health Care

    Columbia, Missouri, 65212

  • OSU

    Columbus, Ohio, 43214

  • Neurocare Of Louisiana

    Covington, Louisiana, 70433

  • Horizon Clinical Research Group

    Cypress, Texas, 77429

  • Clinical Research Solutions LLC

    Cypress, Texas, 77433

  • Neurology Consultants of Dallas, PA

    Dallas, Texas, 75243

  • M3 Wake Research-Dallas

    Dallas, Texas, 75246

  • Premier Health

    Dayton, Ohio, 45409

  • ANESC Research

    El Paso, Texas, 79912

  • Revive Research Institute, Inc.

    Elgin, Illinois, 60123

  • UConn Health

    Farmington, Connecticut, 06030

  • Tarrant Neurology Consultants

    Fort Worth, Texas, 76104

  • Northwell Health

    Great Neck, New York, 11021

  • NEREG

    Hackensack, New Jersey, 07601

  • BCHP

    Hawthorne, New York, 10532

  • Las Mercedes Medical Research

    Hialeah, Florida, 33012

  • Coral Clinic Research

    Homestead, Florida, 33032

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817

  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030

  • UTHealth Houston

    Houston, Texas, 77030

  • UTHSC

    Houston, Texas, 77030

  • University of Florida (Jacksonville)

    Jacksonville, Florida, 32209

  • Dm Healthworks

    Kissimmee, Florida, 34741

  • University of California San Diego

    La Jolla, California, 92041

  • Amicis Research Center

    Lancaster, California, 93534

  • Bluegrass Epilepsy Research

    Lexington, Kentucky, 40504

  • Somnos Clinical Research

    Lincoln, Nebraska, 68510

  • Clinical Trials, Inc.

    Little Rock, Arkansas, 72205

  • Inst of Neurology

    Livingston, New Jersey, 07039

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

    Long Beach, California, 90806

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Tekton Research

    Marlboro, New Jersey, 07746

  • Medstar Health Research Institute

    McLean, Virginia, 22101

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38103

  • University of Miami

    Miami, Florida, 33136

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

    Miami, Florida, 33144

  • Serenity Research Center

    Miami, Florida, 33176

  • Floridian Research Institute

    Miami, Florida, 33179

  • Tri Valley Neurology Medical Associates, Inc.

    Mission Hills, California, 91345

  • Accellacare

    Mooresville, North Carolina, 28117

  • Intermountain Health

    Murray, Utah, 84107

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

  • Yale School of Medicine - Yale-New Haven Hospital

    New Haven, Connecticut, 06519

  • Northwell Health

    New Hyde Park, New York, 11042

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • DelRicht Research

    New Orleans, Louisiana, 70119

  • NYU Langone Health

    New York, New York, 10016

  • NYU

    New York, New York, 10016

  • AdventHealth Orlando

    Orlando, Florida, 32804

  • Research Institute of Orlando

    Orlando, Florida, 32806

  • Comprehensive Neurology Clinic

    Orlando, Florida, 32825

  • Stanford University

    Palo Alto, California, 94304

  • Profound Research LLC

    Pasadena, California, 91105

  • Accelerated Clinical Trials, LLC

    Peachtree Corners, Georgia, 30071

  • Panhandle Research & Medical Clinic

    Pensacola, Florida, 32502

  • Onyx Clinical Trials

    Peoria, Arizona, 85381

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Xenoscience, Inc.

    Phoenix, Arizona, 85004

  • University of Arizona / Banner University Medical Center Phoenix

    Phoenix, Arizona, 85006

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • ARENSIA Exploratory Medicine

    Phoenix, Arizona, 85015

  • AHN

    Pittsburgh, Pennsylvania, 15212

  • UPMC

    Pittsburgh, Pennsylvania, 15213

  • Stryde Research

    Plano, Texas, 75093

  • SRI International

    Plymouth, Michigan, 48170

  • Medsol Clinical Research Center

    Port Charlotte, Florida, 33952

  • Profound Research LLC

    Poway, California, 92065

  • Henrico Doctors Neurology Associates, LLC

    Richmond, Virginia, 23235

  • Carilion Clinic

    Roanoke, Virginia, 24011

  • Revive Research Institute, Inc.

    Rochester Hills, Michigan, 48307

  • Knight Neurology

    Rockledge, Florida, 32955

  • WRN

    Rogers, Arkansas, 72758

  • Minnesota Epilepsy Group, P.A.

    Roseville, Minnesota, 55113

  • University of Utah

    Salt Lake City, Utah, 84132

  • UT Health San Antonio

    San Antonio, Texas, 78229

  • Road Runner Research, Ltd

    San Antonio, Texas, 78249

  • LSU Health Shreveport

    Shreveport, Louisiana, 71103

  • Javara

    Silver Spring, Maryland, 20901

  • Boston Neuro Research

    South Dartmouth, Massachusetts, 02747

  • Oregon Neurology Associates

    Springfield, Oregon, 97477

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stony Brook Medicine

    Stony Brook, New York, 11794

  • PENS

    Tampa, Florida, 33609

  • Santos Research Center

    Tampa, Florida, 33615

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • Encore Medical Research of Weston LLC.

    Weston, Florida, 33331

  • Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

  • Pediatrix Medical Group of Florida

    Winter Park, Florida, 32789

  • Five Towns Neuroscience Research

    Woodmere, New York, 11598

Other trials in United States

Italy17 sites
  • Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Ancona, The Marches, 60121

  • 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

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, 37126

Other trials in Italy

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

Germany16 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

  • LMU Klinikum der Universität München - Campus Großhadern

    München, Bavaria, 81377

  • 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

Poland15 sites
  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomeranian Voivodeship, 80-546

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

    Gdansk, 80-803

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

    Katowice, 40-594

  • Pratia MCM Kraków

    Krakow, 30-727

  • LANDA Specjalistyczne Gabinety Lekarskie

    Krakow, 31-156

  • Santa Familia PTG Lodz

    Lodz, Lódzkie, 90-302

  • Clinical Best Solutions - Lublin

    Lublin, Lublin Voivodeship, 20-078

  • Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o

    Nowa Sól, Lubusz Voivodeship, 67-100

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

    Poznan, Greater Poland Voivodeship, 60-702

  • NZOZ IGNIS dr med. Alicja Lobinska

    Świdnik, Lublin Voivodeship, 21-040

  • MTZ Clinical Research Powered by PRATIA - PPDS

    Warsaw, Masovian Voivodeship, 02-172

  • Neurosphera SP. Z O.O

    Warsaw, Masovian Voivodeship, 02-829

  • Instytut Psychiatrii i Neurologii

    Warsaw, Masovian Voivodeship, 02-957

  • Przychodnia VISTAMED

    Wroclaw, Lower Silesian Voivodeship, 53-149

  • Premium Clinic Wrocław

    Wroclaw, 50-414

Other trials in Poland

United Kingdom11 sites
  • University Hospital of Wales

    Cardiff, South Glamorgan, CF14 4XW

  • Queen Elizabeth University Hospital-PPDS

    Glasgow, Glasgow City, G51 4TF

  • The Walton Centre - PPDS

    Liverpool, Merseyside, L9 7LJ

  • Royal Free Hospital

    London, NW3 2QG

  • 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

Argentina10 sites
  • Hospital General de Agudos Dr. José María Ramos Mejia

    Balvanera, Ciudad Autónoma de BuenosAires, C1221ADC

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

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1431FWO

  • Hospital Británico de Buenos Aires

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1437JCH

  • Sanatorio de la Trinidad - Mitre

    Buenos Aires, C1039AAO

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

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

    Buenos Aires, C1428AQK

  • STAT Research S.A.

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1013AAB

  • Instituto Privado Kremer

    Córdoba, X5004AOA

  • Conci Carpinella - Santa Rosa N° 748

    Córdoba, X5008HHW

  • Investigaciones Sanatorio Del Sur

    San Miguel de Tucumán, Tucumán Province, T4000AXL

Other trials in Argentina

France9 sites
  • CHU Dijon Bourgogne

    Dijon, Côte-d'Or, 21000

  • CHU de Lille - Hopital Claude Huriez

    Lille, Nord, 59037

  • Hospices Civils de Lyon - 59 Bd Pinel

    Lyon, Rhône, 69003

  • CHU de Montpellier- Hôpital Gui De Chauliac

    Montpellier, Hérault, 34295

  • CHRU Nancy

    Nancy, Meurthe-et-Moselle, 54000

  • Hôpital Pontchaillou

    Rennes, 35033

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, Bas-Rhin, 67000

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

    Toulouse, Haute-Garonne, 31059

  • CHRU de Tours - Hôpital Bretonneau

    Tours, Indre-et-Loire, 37000

Other trials in France

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

    Mexico City, 14050

  • Clinstile, S.A. de C.V.

    Mexico City, 6700

  • 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

Portugal6 sites
  • Centro Clínico Académico, Braga - Hospital de Braga

    Braga, 4710-243

  • ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra

    Coimbra, 3000-459

  • 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

Belgium5 sites
  • Hôpital Erasme

    Anderlecht, Brussels Capital, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, Brussels Capital, 1200

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • CHU UCL Namur - Site Godinne

    Yvoir, Namur, 5530

Other trials in Belgium

Chile5 sites
  • Hospital Padre Hurtado

    Santiago, Región-MetropolitanadeSantiago, 8260094

  • BIOCINETIC Ltda

    Santiago, Región-MetropolitanadeSantiago, 8320000

  • Centro de Investigacion Clinica UC

    Santiago, Región-MetropolitanadeSantiago, 8320000

  • Centro de especialidades médicas Vanguardia

    Temuco, Araucania, 4780000

  • Instituto Neurologico Thalamus

    Viña del Mar, Valparaiso, 2520021

Other trials in Chile

Croatia5 sites
  • Clinical Hospital Center Rijeka - PPDS

    Rijeka, 51000

  • Clinical Hospital Dubrava

    Zagreb, City of Zagreb, 10000

  • Clinical Hospital Sveti duh

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Greece5 sites
  • University General Hospital of Alexandroupolis

    Alexandroupoli, 681 00

  • University General Hospital ''ATTIKON''

    Chaïdári, 124 62

  • University General Hospital of Ioannina

    Ioannina, 455 00

  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki, 546 36

  • Georgios Papanikolaou General Hospital of Thessaloniki

    Thessaloniki, 546 36

Other trials in Greece

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

Austria4 sites
  • Kepler Universitätsklinikum Linz - Med Campus III

    Linz, Upper Austria, 4020

  • Christian Doppler-Klinik - Universitätsklinikum der PMU

    Salzburg, 5020

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100

  • Medizinische Universitat Wien (Medical University of Vienna)

    Vienna, 1090

Other trials in Austria

Hungary4 sites
  • Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

    Budapest, 1106

  • SE INK Juhasz Pal Epilepszia Központ

    Budapest, 1145

  • Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus

    Debrecen, Hajdú-Bihar, 4031

  • Pécsi Tudományegyetem Klinikai Kozpont -Ret u.

    Pécs, Baranya, 7623

Other trials in Hungary

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

Netherlands3 sites
  • Stichting Epilepsie Instellingen Nederland - Heemstede

    Heemstede, North Holland, 2103 SW

  • Kempenhaeghe - PPDS

    Heeze, North Brabant, 5591 VE

  • Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20

    Zwolle, Overijssel, 8025 BV

Other trials in Netherlands

Czechia2 sites
  • Fakultni nemocnice u sv. Anny v Brne

    Brno, South Moravian, 602 00

  • Fakultni nemocnice v Motole

    Prague, Praha, Hlavní Mesto, 150 06

Other trials in Czechia

Romania2 sites
  • Emergency University Hospital

    Bucharest, 11635

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

    Târgu Mureş, Mureș County, 540136

Other trials in Romania

Slovakia2 sites
  • IN MEDIC, s.r.o.

    Bardejov, 085 01

  • Kraskova 2636, Neurologické oddelenie

    Rimavská Sobota, 979 01

Other trials in Slovakia

South Africa2 sites
  • InnoMed Clinical Trial Centre

    Cape Town, Western Cape, 7530

  • Groote Schuur Hospital

    Cape Town, Western Cape, 7700

Other trials in South Africa

Slovenia1 site
  • University Clinical Centre Maribor

    Maribor, 2000

Other trials in Slovenia

Switzerland1 site
  • Klinik Lengg AG

    Zurich, Zürich (de), 8008

Other trials in Switzerland

About this study

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

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

Conditions
Focal Epilepsy
Being tested
BHV-7000
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 open-label investigational product (IP) once daily

  • BHV-7000Drug

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

Study groups in NCT06443463
Study groupRoleWhat they receive
BHV-7000 50 mgExperimentalNot described
Receives: Drug: BHV-7000
BHV-7000 75 mgExperimentalNot described
Receives: Drug: BHV-7000

What is being measured

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

  1. 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: Up to 104 weeks

  2. Number of Subjects 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: Up to 104 weeks

Timeline

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

  1. First posted5 Jun 2024
  2. Study start30 Jul 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionJan 2027 (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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
660 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06443463
Sponsor's protocol ID
BHV7000-201
Other IDs
2023-508813-18-00, 2023
Status last verified
Apr 2026
First submitted
30 May 2024
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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