Long-term Safety and Tolerability of BHV-7000

April 30, 2026 updated by: Biohaven Therapeutics Ltd.

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

660

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, C1428AQK
        • Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
      • Buenos Aires, Argentina, C1039AAO
        • Sanatorio de la Trinidad - Mitre
      • Córdoba, Argentina, X5004AOA
        • Instituto Privado Kremer
      • Córdoba, Argentina, X5008HHW
        • Conci Carpinella - Santa Rosa N° 748
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1013AAB
        • Stat Research S.A.
    • Ciudad Autónoma de BuenosAires
      • Balvanera, Ciudad Autónoma de BuenosAires, Argentina, C1221ADC
        • Hospital General de Agudos Dr. José María Ramos Mejia
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1431FWO
        • Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1437JCH
        • Hospital Britanico de Buenos Aires
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • Investigaciones Sanatorio Del Sur
  • Australia
      • Bedford Park, Australia, 5042
        • Flinders Medical Centre
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane & Women's Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincents Hospital Melbourne - PPDS
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Austria
      • Salzburg, Austria, 5020
        • Christian Doppler-Klinik - Universitätsklinikum der PMU
      • Sankt Pölten, Austria, 3100
        • Universitätsklinikum St. Pölten
      • Vienna, Austria, 1090
        • Medizinische Universität Wien (Medical University of Vienna)
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Kepler Universitätsklinikum Linz - Med Campus III
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • UZ Antwerpen
    • Brussels Capital
      • Anderlecht, Brussels Capital, Belgium, 1070
        • Hopital Erasme
      • Brussels, Brussels Capital, Belgium, 1200
        • Cliniques Universitaires Saint-luc
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • CHU UCL Namur - Site Godinne
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4780000
        • Centro de especialidades médicas Vanguardia
    • Región-MetropolitanadeSantiago
      • Santiago, Región-MetropolitanadeSantiago, Chile, 8260094
        • Hospital Padre Hurtado
      • Santiago, Región-MetropolitanadeSantiago, Chile, 8320000
        • BIOCINETIC Ltda
      • Santiago, Región-MetropolitanadeSantiago, Chile, 8320000
        • Centro de investigación Clinica UC
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520021
        • Instituto Neurologico Thalamus
  • Croatia
      • Rijeka, Croatia, 51000
        • Clinical Hospital Center Rijeka - PPDS
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Clinical Hospital Dubrava
      • Zagreb, City of Zagreb, Croatia, 10000
        • Clinical Hospital Sveti Duh
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Zagreb
  • Czechia
    • Praha, Hlavní Mesto
      • Prague, Praha, Hlavní Mesto, Czechia, 150 06
        • Fakultni nemocnice v Motole
    • South Moravian
      • Brno, South Moravian, Czechia, 602 00
        • Fakultni nemocnice u sv. Anny v Brne
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital
      • Dianalund, Denmark, 4293
        • Epilepsihospitalet Filadelfia
    • Fyn
      • Odense, Fyn, Denmark, 5000
        • Odense Universitetshospital
  • Finland
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70200
        • Kuopion Yliopistollinen Sairaala
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Tampereen Yliopistollinen Sairaala
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Helsinki University Hospital
  • France
      • Rennes, France, 35033
        • Hopital Pontchaillou
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67000
        • CHU de Strasbourg - Hôpital de Hautepierre
    • Côte-d'Or
      • Dijon, Côte-d'Or, France, 21000
        • CHU Dijon Bourgogne
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
    • Hérault
      • Montpellier, Hérault, France, 34295
        • CHU de Montpellier- Hôpital Gui De Chauliac
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37000
        • CHRU de Tours - Hôpital Bretonneau
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, France, 54000
        • Chru Nancy
    • Nord
      • Lille, Nord, France, 59037
        • CHU de LILLE - Hopital Claude Huriez
    • Rhône
      • Lyon, Rhône, France, 69003
        • Hospices Civils de Lyon - 59 Bd Pinel
  • Germany
      • Berlin, Germany, 13509
        • Vivantes - Humboldt Klinikum
      • Frankfurt, Germany, 60590
        • Universitatsklinikum Frankfurt
      • Ravensburg, Germany, 88214
        • Epilepsie-Zentrum Bodensee
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Universitatsklinikum Freiburg
      • Kehl, Baden-Wurttemberg, Germany, 77694
        • Epilepsiezentrum Kork
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Universitatsklinikum Ulm
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Universitatsklinikum Erlangen
      • München, Bavaria, Germany, 81377
        • LMU Klinikum der Universität München - Campus Grosshadern
    • Brandenburg
      • Bernau bei Berlin, Brandenburg, Germany, 16321
        • Epilepsieklinik Tabor
    • Hesse
      • Marburg, Hesse, Germany, 35043
        • Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
    • Lower Saxony
      • Osnabrück, Lower Saxony, Germany, 49076
        • Klinikum Osnabrück GmbH
    • North Rhine-Westphalia
      • Bielefeld, North Rhine-Westphalia, Germany, 33617
        • Krankenhaus Mara gGmbH
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Universitatsklinikum Bonn
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Universitatsklinikum Munster
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Universitätsklinikum Leipzig
      • Radeberg, Saxony, Germany, 01454
        • Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
  • Greece
      • Alexandroupoli, Greece, 681 00
        • University General Hospital of Alexandroupolis
      • Chaïdári, Greece, 124 62
        • University General Hospital ''ATTIKON''
      • Ioannina, Greece, 455 00
        • University General Hospital of Ioannina
      • Thessaloniki, Greece, 546 36
        • Ahepa University General Hospital of Thessaloniki
      • Thessaloniki, Greece, 546 36
        • Georgios Papanikolaou General Hospital of Thessaloniki
  • Hungary
      • Budapest, Hungary, 1106
        • Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
      • Budapest, Hungary, 1145
        • SE INK Juhasz Pal Epilepszia Központ
    • Baranya
      • Pécs, Baranya, Hungary, 7623
        • Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4031
        • Debreceni Egyetem Klinikai Központ Kenézy Gyula Campus
  • India
      • Hyderabad, India, 500082
        • Nizam's Insti. of Medical Sciences
      • Mangalore, India, 575002
        • Mallikatta Neuro Centre
      • Mumbai, India, 400026
        • Jaslok Hospital and Research
      • Nagpur, India, 440010
        • Dr G M Taori Memorial CIIMS
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences (AIIMS)
  • Italy
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario A Gemelli-Rome
      • Rome, Italy, 00165
        • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
      • Verona, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata di Verona
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66013
        • Università degli Studi G. D'Annunzio Chieti-Pescara
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
    • Campania
      • Naples, Campania, Italy, 80131
        • AORN Antonio Cardarelli
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40123
        • AUSL di Bologna - Ospedale Bellaria
    • Lazio
      • Rome, Lazio, Italy, 00133
        • Fondazione PTV Policlinico Tor Vergata
    • Liguria
      • Genoa, Liguria, Italy, 16147
        • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Ospedale San Raffaele S.r.l. - PPDS
      • Milan, Lombardy, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
      • Milan, Lombardy, Italy, 20142
        • ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
      • Pavia, Lombardy, Italy, 27100
        • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
    • Modena
      • Baggiovara, Modena, Italy, 41126
        • Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
    • Molise
      • Pozzilli, Molise, Italy, 86077
        • IRCCS Istituto Neurologico Mediterraneo Neuromed
    • The Marches
      • Ancona, The Marches, Italy, 60121
        • Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
    • Tuscany
      • Calambrone, Tuscany, Italy, 56018
        • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
  • Mexico
      • Mexico City, Mexico, 14050
        • Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
      • Mexico City, Mexico, 6700
        • Clinstile, S.A. de C.V.
      • Monterrey, Mexico, 64000
        • Accelerium, S. de R.L. de C.V. - PPDS
      • Obispado, Mexico, 64060
        • Axis Heilsa S. de R.L. de C.V.
      • Sinaloa, Mexico, 80020
        • Neurociencias Estudios Clinicos S.C.
      • Tlalnepantla, Mexico, 54055
        • Clinical Research Institute SC-Mexico
      • Veracruz, Mexico, 91900
        • FAICIC S De RL De CV
  • Netherlands
    • North Brabant
      • Heeze, North Brabant, Netherlands, 5591 VE
        • Kempenhaeghe - PPDS
    • North Holland
      • Heemstede, North Holland, Netherlands, 2103 SW
        • Stichting Epilepsie Instellingen Nederland - Heemstede
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 BV
        • Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20
  • Poland
      • Gdansk, Poland, 80-803
        • Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6
      • Katowice, Poland, 40-594
        • Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44
      • Krakow, Poland, 30-727
        • Pratia MCM Krakow
      • Krakow, Poland, 31-156
        • LANDA Specjalistyczne Gabinety Lekarskie
      • Wroclaw, Poland, 50-414
        • Premium Clinic Wrocław
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-702
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-149
        • Przychodnia Vistamed
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-078
        • Clinical Best Solutions - Lublin
      • Świdnik, Lublin Voivodeship, Poland, 21-040
        • NZOZ IGNIS dr med. Alicja Lobinska
    • Lubusz Voivodeship
      • Nowa Sól, Lubusz Voivodeship, Poland, 67-100
        • Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
    • Lódzkie
      • Lodz, Lódzkie, Poland, 90-302
        • Santa Familia PTG Lodz
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-172
        • MTZ Clinical Research Powered by PRATIA - PPDS
      • Warsaw, Masovian Voivodeship, Poland, 02-829
        • Neurosphera SP. Z O.O
      • Warsaw, Masovian Voivodeship, Poland, 02-957
        • Instytut Psychiatrii i Neurologii
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Portugal
      • Braga, Portugal, 4710-243
        • Centro Clínico Académico, Braga - Hospital de Braga
      • Coimbra, Portugal, 3000-459
        • ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
      • Lisbon, Portugal, 1449-005
        • ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
      • Lisbon, Portugal, 1600-209
        • Hospital da Luz Torres de Lisboa
    • Aveiro District
      • Santa Maria da Feira, Aveiro District, Portugal, 4520-211
        • ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
    • Porto District
      • Senhora da Hora, Porto District, Portugal, 4454-509
        • ULS de Matosinhos, EPE - Hospital Pedro Hispano
  • Romania
      • Bucharest, Romania, 11635
        • Emergency University Hospital
    • Mureș County
      • Târgu Mureş, Mureș County, Romania, 540136
        • Targu-Mures Emergency Clinical County Hospital - Str. Gh. Marinescu nr.50
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • IN MEDIC, s.r.o.
      • Rimavská Sobota, Slovakia, 979 01
        • Kraskova 2636, Neurologické oddelenie
  • Slovenia
      • Maribor, Slovenia, 2000
        • University Clinical Centre Maribor
  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7700
        • Groote Schuur Hospital
      • Cape Town, Western Cape, South Africa, 7530
        • InnoMed Clinical Trial Centre
  • Spain
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron - PPDS
      • Barcelona, Spain, 08221
        • Fundacio Assistencial Mutua de Terrassa
      • Granada, Spain, 18007
        • Hospital Universitario Clínico San Cecilio
      • Granada, Spain, 18008
        • Hospital Vithas Granada
      • Granada, Spain, 18013
        • Hospital Universitario Virgen de las Nieves
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28034
        • Hospital Ruber Internacional (Grupo Quironsalud)
      • Madrid, Spain, 28055
        • Hospital Blua Sanitas Valdebebas
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Malaga - Hospital General
      • Seville, Spain, 41013
        • Centro de Neurologia Avanzada
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
      • Valladolid, Spain, 47003
        • Hospital Clinico Universitario de Valladolid
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Hospital Universitario de Navarra
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • CHUVI - H.U. Alvaro Cunqueiro
  • Switzerland
    • Zürich (de)
      • Zurich, Zürich (de), Switzerland, 8008
        • Klinik Lengg AG
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom, SW17 0QT
        • St Georges NHS Foundation Trust
      • London, United Kingdom, WC1N 3HR
        • The Royal London Hospital
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
    • Glamorgan
      • Swansea, Glamorgan, United Kingdom, SA6 6NL
        • Morriston Hospital
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital-PPDS
    • Manchester
      • Salford, Manchester, United Kingdom, M6 8HD
        • Salford Royal Hospital - PPDS
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L9 7LJ
        • The Walton Centre - PPDS
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF14 4XW
        • University Hospital of Wales
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Accel Research
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Onyx Clinical Trials
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
      • Phoenix, Arizona, United States, 85004
        • Xenoscience, Inc.
      • Phoenix, Arizona, United States, 85015
        • Arensia Exploratory Medicine
      • Phoenix, Arizona, United States, 85006
        • University of Arizona / Banner University Medical Center Phoenix
      • Tucson, Arizona, United States, 85718
        • Center for Neurosciences
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Clinical Trials, Inc.
      • Rogers, Arkansas, United States, 72758
        • WRN
    • California
      • La Jolla, California, United States, 92041
        • University Of California San Diego
      • Lancaster, California, United States, 93534
        • Amicis Research Center
      • Long Beach, California, United States, 90806
        • Memorialcare Miller Children's & Women's Hospital Long Beach
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
      • Mission Hills, California, United States, 91345
        • Tri Valley Neurology Medical Associates, Inc.
      • Palo Alto, California, United States, 94304
        • Stanford University
      • Pasadena, California, United States, 91105
        • Profound Research LLC
      • Poway, California, United States, 92065
        • Profound Research LLC
    • Colorado
      • Aurora, Colorado, United States, 80011
        • Kaiser Permanente
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschultz Medical Campus
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • UConn Health
      • New Haven, Connecticut, United States, 06519
        • Yale School of Medicine - Yale-New Haven Hospital
    • Florida
      • Boca Raton, Florida, United States, 33486
        • EZR Research LLC
      • Bradenton, Florida, United States, 34209
        • Nova Clinical Research, LLC
      • Hialeah, Florida, United States, 33012
        • Las Mercedes Medical Research
      • Homestead, Florida, United States, 33032
        • Coral Clinic Research
      • Jacksonville, Florida, United States, 32209
        • University of Florida (Jacksonville)
      • Kissimmee, Florida, United States, 34741
        • Dm Healthworks
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33179
        • Floridian Research Institute
      • Miami, Florida, United States, 33144
        • Y&L Advance Health Care, Inc d/b/a Elite Clinical Research
      • Miami, Florida, United States, 33176
        • Serenity Research Center
      • Orlando, Florida, United States, 32804
        • AdventHealth Orlando
      • Orlando, Florida, United States, 32806
        • Research Institute of Orlando
      • Orlando, Florida, United States, 32825
        • Comprehensive Neurology Clinic
      • Pensacola, Florida, United States, 32502
        • Panhandle Research & Medical Clinic
      • Port Charlotte, Florida, United States, 33952
        • Medsol Clinical Research Center
      • Rockledge, Florida, United States, 32955
        • Knight Neurology
      • Tampa, Florida, United States, 33615
        • Santos Research Center
      • Tampa, Florida, United States, 33609
        • PENS
      • Weston, Florida, United States, 33331
        • Encore Medical Research of Weston LLC.
      • Winter Park, Florida, United States, 32789
        • Pediatrix Medical Group of Florida
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University
      • Peachtree Corners, Georgia, United States, 30071
        • Accelerated Clinical Trials, LLC
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Pacific Neuroscience
    • Idaho
      • Boise, Idaho, United States, 83702
        • Consultants in Epilepsy & Neurology, PLLC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Elgin, Illinois, United States, 60123
        • Revive Research Institute, Inc.
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Bluegrass Epilepsy Research
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • OLOLRMC
      • Baton Rouge, Louisiana, United States, 70810
        • DelRicht Research
      • Covington, Louisiana, United States, 70433
        • Neurocare Of Louisiana
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
      • New Orleans, Louisiana, United States, 70119
        • DelRicht Research
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Shreveport
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • John Hopkins University
      • Bethesda, Maryland, United States, 20817
        • Mid-Atlantic Epilepsy & Sleep Center, LLC
      • Silver Spring, Maryland, United States, 20901
        • Javara
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Boston Clinical Trials
      • South Dartmouth, Massachusetts, United States, 02747
        • Boston Neuro Research
    • Michigan
      • Plymouth, Michigan, United States, 48170
        • SRI International
      • Rochester Hills, Michigan, United States, 48307
        • Revive Research Institute, Inc.
    • Minnesota
      • Roseville, Minnesota, United States, 55113
        • Minnesota Epilepsy Group, P.A.
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Health Care
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Somnos Clinical Research
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • NEREG
      • Livingston, New Jersey, United States, 07039
        • Inst of Neurology
      • Marlboro, New Jersey, United States, 07746
        • Tekton Research
      • Neptune City, New Jersey, United States, 07753
        • Jersey Shore Medical Center
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurosciences Research Center
      • Great Neck, New York, United States, 11021
        • Northwell Health
      • Hawthorne, New York, United States, 10532
        • BCHP
      • New Hyde Park, New York, United States, 11042
        • Northwell Health
      • New York, New York, United States, 10016
        • NYU Langone Health
      • New York, New York, United States, 10016
        • NYU
      • Stony Brook, New York, United States, 11794
        • Stony Brook Medicine
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Woodmere, New York, United States, 11598
        • Five Towns Neuroscience Research
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC-Chapel Hill
      • Charlotte, North Carolina, United States, 28211
        • Onsite Clinical Solutions
      • Mooresville, North Carolina, United States, 28117
        • Accellacare
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist
    • Ohio
      • Canton, Ohio, United States, 44718
        • NeuroScience Research Center
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Columbus, Ohio, United States, 43214
        • OSU
      • Dayton, Ohio, United States, 45409
        • Premier Health
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Oregon Neurology Associates
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC
      • Pittsburgh, Pennsylvania, United States, 15212
        • AHN
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • WR-ClinSearch
      • Memphis, Tennessee, United States, 38103
        • Le Bonheur Children's Hospital
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Cypress, Texas, United States, 77429
        • Horizon Clinical Research Group
      • Cypress, Texas, United States, 77433
        • Clinical Research Solutions LLC
      • Dallas, Texas, United States, 75243
        • Neurology Consultants of Dallas, PA
      • Dallas, Texas, United States, 75246
        • M3 Wake Research-Dallas
      • El Paso, Texas, United States, 79912
        • ANESC Research
      • Fort Worth, Texas, United States, 76104
        • Tarrant Neurology Consultants
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center
      • Houston, Texas, United States, 77030
        • UTHealth Houston
      • Houston, Texas, United States, 77030
        • UTHSC
      • Plano, Texas, United States, 75093
        • Stryde Research
      • San Antonio, Texas, United States, 78229
        • UT Health San Antonio
      • San Antonio, Texas, United States, 78249
        • Road Runner Research, Ltd
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Health
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Vermont
      • Burlington, Vermont, United States, 05401
        • UVM MC
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
      • McLean, Virginia, United States, 22101
        • MedStar Health Research Institute
      • Richmond, Virginia, United States, 23235
        • Henrico Doctors Neurology Associates, LLC
      • Roanoke, Virginia, United States, 24011
        • Carilion Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BHV-7000 50 mg
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
Experimental: BHV-7000 75 mg
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
Time Frame: Up to 104 weeks
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.
Up to 104 weeks
Number of Subjects with Clinically Significant Laboratory Abnormalities
Time Frame: Up to 104 weeks
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.
Up to 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biohaven Therapeutics Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHV7000-201
  • 2023-508813-18-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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