NCT06443463Enrolling by invitationPhase 2
Long-term Safety and Tolerability of BHV-7000
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
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 660 (estimated)
- First submitted
- 30 May 2024
- Start date
- 30 Jul 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Biohaven Therapeutics Ltd.
- Diseases
- Epilepsy
- NCT number
- NCT06443463
- EU CT number
- 2023-508813-18-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 660
- From 30 Jul 2024 to the primary completion date, 31 Dec 2026
- 280 sites in 27 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (280)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General de Agudos Dr. José María Ramos Mejia Coordinator of this site? Confirm its status | Balvanera | Argentina | Unknown status |
| Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Britanico de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Sanatorio de la Trinidad - Mitre Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Stat Research S.A. Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Unknown status |
| Instituto Privado Kremer Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Conci Carpinella - Santa Rosa N° 748 Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Investigaciones Sanatorio Del Sur Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Johannes Kepler University Linz Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Salzburg | Austria | Recruiting |
| Noe LGA Gesundheit Region Mitte GmbH Coordinator of this site? Confirm its status | St. Poelten | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Flinders Medical Centre Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| St Vincents Hospital Melbourne - PPDS Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Royal Brisbane & Women s Hospital Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Randwick | Australia | Unknown status |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Yvoir | Belgium | Recruiting |
| Klinik Lengg AG Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Centro de Investigacion Clinica UC Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Hospital Padre Hurtado Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Biocinetic Ltda Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Centro de especialidades médicas Vanguardia Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| Instituto Neurologico Thalamus Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Fakultni Nemocnice U Sv Anny V Brne Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Recruiting |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Vivantes Netzwerk fuer Gesundheit GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Gesellschaft Fuer Epilepsieforschung Coordinator of this site? Confirm its status | Bielefeld | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| Diakonie Kork Coordinator of this site? Confirm its status | Kehl | Germany | Recruiting |
| Universitaetsklinikum Leipzig Aor Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Philipps-Universitaet Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Klinikum Osnabrueck GmbH Coordinator of this site? Confirm its status | Osnabrueck | Germany | Recruiting |
| Epilepsiezentrum Kleinwachau gGmbH Coordinator of this site? Confirm its status | Radeberg | Germany | Recruiting |
| ZfP Südwürttemberg Coordinator of this site? Confirm its status | Ravensburg | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Filadelfia Coordinator of this site? Confirm its status | Dianalund | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Hospital Vithas La Salud Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Ruber Internacional Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Blua Sanitas Valdebebas Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Centro De Neurologia Avanzada S.L.P. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Fundacio Assistencial De Mutua De Terrassa Fpc Coordinator of this site? Confirm its status | Terrassa | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
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| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Recruiting |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| Pohjois-Savon hyvinvointialue Coordinator of this site? Confirm its status | Kuopio | Finland | Recruiting |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Nancy Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Centre Hospitalier Régional Universitaire de Tours Coordinator of this site? Confirm its status | Tours | France | Recruiting |
| University Hospital of Wales Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Queen Elizabeth University Hospital - PPDS Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| The Walton Centre - PPDS Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| St Georges NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Free Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Victoria Infirmary Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Salford Royal Hospital - PPDS Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| Morriston Hospital Coordinator of this site? Confirm its status | Swansea | United Kingdom | Unknown status |
| University General Hospital of Alexandroupoli Coordinator of this site? Confirm its status | Alexandroupoli | Greece | Recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Coordinator of this site? Confirm its status | Chaïdári | Greece | Recruiting |
| University General Hospital of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Recruiting |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| University General Hospital of Thessaloniki - AHEPA Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Klinicki bolnicki centar Sestre milosrdnice Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Completed |
| Clinical Hospital Centre Rijeka Coordinator of this site? Confirm its status | Rijeka | Croatia | Completed |
| University Hospital Sveti Duh Coordinator of this site? Confirm its status | Zagreb | Croatia | Completed |
| University Hospital Centre Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Completed |
| Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest XIV | Hungary | Recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Recruiting |
| Nizam's Insti. of Medical Sciences Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Mallikatta Neuro Centre Coordinator of this site? Confirm its status | Mangalore | India | Unknown status |
| Jaslok Hospital and Research Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Dr G M Taori Memorial CIIMS Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| All India Institute of Medical Sciences(AIIMS) Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Renato Dulbecco Coordinator of this site? Confirm its status | Catanzaro | Italy | Recruiting |
| Universita' Degli Studi G. D'Annunzio Di Chieti Coordinator of this site? Confirm its status | Chieti Scalo | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| IRCCS Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Istituto Neurologico Mediterraneo Neuromed S.p.A. Coordinator of this site? Confirm its status | Pozzilli | Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| Clinstile, S.A. de C.V. Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Accelerium, S. de R.L. de C.V. - PPDS Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Axis Heilsa S. de R.L. de C.V. Coordinator of this site? Confirm its status | Obispado | Mexico | Unknown status |
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| Clinical Research Institute SC-Mexico Coordinator of this site? Confirm its status | Tlalnepantla | Mexico | Unknown status |
| Faicic S de RL de CV Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| Epilepsie Instellingen Nederland Stichting Coordinator of this site? Confirm its status | Heemstede | Netherlands | Recruiting |
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| Delricht Research Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYU Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Research Institute of Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Comprehensive Neurology Clinic Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| AdventHealth Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Profound Research LLC Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| Accelerated Clinical Trials, LLC Coordinator of this site? Confirm its status | Peachtree Corners | United States | Unknown status |
| Panhandle Research & Medical Clinic Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Onyx Clinical Trials Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Arizona/Banner University Medical Center Phoenix Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Xenoscience Inc. Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| ARENSIA Exploratory Medicine Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Barrow Neurological Institute Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| AHN Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Stryde Research Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| SRI International Coordinator of this site? Confirm its status | Plymouth | United States | Unknown status |
| Medsol Clinical Research Center Coordinator of this site? Confirm its status | Port Charlotte | United States | Unknown status |
| Profound Research LLC Coordinator of this site? Confirm its status | Poway | United States | Unknown status |
| Henrico Doctors Neurology Associates, LLC Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Carilion Clinic Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| Revive Research Institute, Inc. Coordinator of this site? Confirm its status | Rochester Hills | United States | Unknown status |
| Knight Neurology Coordinator of this site? Confirm its status | Rockledge | United States | Unknown status |
| WRN Coordinator of this site? Confirm its status | Rogers | United States | Unknown status |
| Minnesota Epilepsy Group, P.A. Coordinator of this site? Confirm its status | Roseville | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| UT Health San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Road Runner Research, Ltd Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| LSU Health Shreveport Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| Javara Coordinator of this site? Confirm its status | Silver Spring | United States | Unknown status |
| Boston Neuro Research Coordinator of this site? Confirm its status | South Dartmouth | United States | Unknown status |
| Oregon Neurology Associates Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Stony Brook Medicine Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
| PENS Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Santos Research Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Center for Neurosciences Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Encore Medical Research of Weston, LLC Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
| Wake Forest Baptist Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| Pediatrix Medical Group of Florida Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
| Five Towns Neuroscience Research Coordinator of this site? Confirm its status | Woodmere | United States | Unknown status |
| Groote Schuur Hospital Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| InnoMed Clinical Trial Centre Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.