Long-term Safety and Tolerability of BHV-7000

Phase 2

• Conditions: Focal Epilepsy
• Interventions: Drug: BHV-7000

• Registration Number: NCT06443463
• Lead Sponsor: Biohaven Therapeutics Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-05-30
• Study First Posted: 2024-06-05
• Study Start: 2024-07-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-12
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 660

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BHV-7000 50 mg	BHV-7000	-
BHV-7000 75 mg	BHV-7000	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs	Up to 52 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.
Number of Subjects with Clinically Significant Laboratory Abnormalities	Up to 52 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.

Trial Locations

Locations (228)

Hospital Ruber Internacional (Grupo Quironsalud); 🇪🇸 Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Regional Universitario de Malaga - Hospital General; 🇪🇸 Málaga, Spain

Centro de Neurologia Avanzada; 🇪🇸 Sevilla, Spain

Hospital Universitari i Politecnic La Fe de Valencia; 🇪🇸 Valencia, Spain

Hospital Clinico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

University Clinical Centre Maribor; 🇸🇮 Maribor, Slovenia

Research Institute of Orlando; 🇺🇸 Orlando, Florida, United States

Comprehensive Neurology Clinic; 🇺🇸 Orlando, Florida, United States

Accel Research; 🇺🇸 Birmingham, Alabama, United States

Xenoscience, Inc.; 🇺🇸 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

Stanford University; 🇺🇸 Palo Alto, 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

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

Hospital da Luz Torres de Lisboa; 🇵🇹 Lisboa, Portugal

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

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.; 🇺🇸 Rochester Hills, Michigan, 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

Vivantes - Humboldt Klinikum; 🇩🇪 Berlin, Germany

University Medical Center New Orleans; 🇺🇸 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

Minnesota Epilepsy Group, P.A.; 🇺🇸 Roseville, Minnesota, United States

Washington University School of Medicine; 🇺🇸 Saint 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

Dent Neurosciences Research Center; 🇺🇸 Amherst, New York, United States

Northwell Health; 🇺🇸 New York, New York, United States

BCHP; 🇺🇸 Hawthorne, 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

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

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

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

Clinical Research Solutions LLC; 🇺🇸 Cypress, Texas, United States

Neurology Consultants of Dallas, PA; 🇺🇸 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

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, Argentina

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Argentina

Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI; 🇦🇷 Ciudad Autónoma de 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

Kepler Universitätsklinikum Linz - Med Campus III; 🇦🇹 Linz, Oberösterreich, Austria

Christian Doppler-Klinik - Universitätsklinikum der PMU; 🇦🇹 Salzburg, Austria

Universitätsklinikum St. Pölten; 🇦🇹 St. Pölten, Austria

Medizinische Universitat Wien (Medical University of Vienna); 🇦🇹 Wien, Austria

UZ Antwerpen; 🇧🇪 Edegem, Antwerpen, Belgium

Hôpital Erasme; 🇧🇪 Anderlecht, Brussels, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Bruxelles, Brussels, Belgium

CHU UCL Namur - Site Godinne; 🇧🇪 Yvoir, Namur, Belgium

UZ Gent; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

Centro de especialidades médicas Vanguardia; 🇨🇱 Temuco, Araucanía, Chile

Hospital Padre Hurtado; 🇨🇱 Santiago, Región-MetropolitanadeSantiago, Chile

BIOCINETIC Ltda; 🇨🇱 Santiago, Región-MetropolitanadeSantiago, Chile

Centro de Investigacion Clinica UC; 🇨🇱 Santiago, Región-MetropolitanadeSantiago, Chile

Instituto Neurologico Thalamus; 🇨🇱 Viña del Mar, Valparaíso, Chile

Clinical Hospital Dubrava; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Clinical Hospital Sveti duh; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Klinicki bolnicki centar Zagreb; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Clinical Hospital Center Rijeka - PPDS; 🇭🇷 Rijeka, Croatia

Fakultni nemocnice u sv. Anny v Brne; 🇨🇿 Brno, Jihomoravský Kraj, Czechia

Fakultni nemocnice v Motole; 🇨🇿 Praha, Praha, Hlavní Mesto, Czechia

Odense Universitetshospital; 🇩🇰 Odense, Fyn, Denmark

Tampereen yliopistollinen sairaala; 🇫🇮 Tampere, Pirkanmaa, Finland

Kuopion yliopistollinen sairaala; 🇫🇮 Kuopio, Pohjois-Savo, 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 Cedex, Nord, France

Hospices Civils de Lyon - 59 Bd Pinel; 🇫🇷 Lyon, Rhône, France

Hôpital Pontchaillou; 🇫🇷 Rennes, France

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Baden-Württemberg, Germany

Epilepsiezentrum Kork; 🇩🇪 Kehl, Baden-Württemberg, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Bayern, Germany

LMU Klinikum der Universität München - Campus Großhadern; 🇩🇪 München, Bayern, Germany

Epilepsieklinik Tabor; 🇩🇪 Bernau bei Berlin, Brandenburg, Germany

Klinikum der Johann-Wolfgang Goethe-Universitat - Schleusenweg 2-16; 🇩🇪 Frankfurt am Main, Hessen, Germany

Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg; 🇩🇪 Marburg, Hessen, Germany

Klinikum Osnabrück GmbH; 🇩🇪 Osnabrück, Niedersachsen, Germany

Krankenhaus Mara gGmbH; 🇩🇪 Bielefeld, Nordrhein-Westfalen, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, Nordrhein-Westfalen, Germany

Epilepsie-Zentrum Bodensee; 🇩🇪 Ravensburg, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Sachsen, Germany

Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh; 🇩🇪 Radeberg, Sachsen, Germany

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

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; 🇮🇹 Napoli, Campania, Italy

AUSL di Bologna - Ospedale Bellaria; 🇮🇹 Bologna, Emilia-Romagna, Italy

Fondazione PTV Policlinico Tor Vergata; 🇮🇹 Roma, Lazio, Italy

Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN; 🇮🇹 Genova, Liguria, Italy

Ospedale San Raffaele S.r.l. - PPDS; 🇮🇹 Milano, Lombardia, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta; 🇮🇹 Milano, Lombardia, Italy

ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo; 🇮🇹 Milano, Lombardia, Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS; 🇮🇹 Pavia, Lombardia, Italy

Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona; 🇮🇹 Ancona, Marche, Italy

Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara; 🇮🇹 Baggiovara, Modena, Italy

IRCCS Istituto Neurologico Mediterraneo Neuromed; 🇮🇹 Pozzilli, Molise, Italy

Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN; 🇮🇹 Calambrone, Toscana, 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

Kempenhaeghe - PPDS; 🇳🇱 Heeze, Noord-Brabant, Netherlands

Stichting Epilepsie Instellingen Nederland - Heemstede; 🇳🇱 Heemstede, Noord-Holland, Netherlands

Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20; 🇳🇱 Zwolle, Overijssel, Netherlands

Przychodnia VISTAMED; 🇵🇱 Wrocław, Dolnoslaskie, Poland

Clinical Best Solutions - Lublin; 🇵🇱 Lublin, Lubelskie, Poland

NZOZ IGNIS dr med. Alicja Lobinska; 🇵🇱 Świdnik, Lubelskie, Poland

Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o; 🇵🇱 Nowa Sól, Lubuskie, Poland

Santa Familia PTG Lodz; 🇵🇱 Łódź, Lódzkie, Poland

MTZ Clinical Research Powered by PRATIA - PPDS; 🇵🇱 Warszawa, Mazowieckie, Poland

Neurosphera SP. Z O.O; 🇵🇱 Warszawa, Mazowieckie, Poland

Instytut Psychiatrii i Neurologii; 🇵🇱 Warszawa, Mazowieckie, Poland

Centrum Badan Klinicznych PI-House sp. z o.o.; 🇵🇱 Gdansk, Pomorskie, Poland

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu; 🇵🇱 Poznań, Wielkopolskie, Poland

Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6; 🇵🇱 Gdańsk, Poland

Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44; 🇵🇱 Katowice, Poland

Pratia MCM Kraków; 🇵🇱 Kraków, Poland

LANDA Specjalistyczne Gabinety Lekarskie; 🇵🇱 Kraków, Poland

ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião; 🇵🇹 Santa Maria Da Feira, Aveiro, Portugal

ULS de Matosinhos, EPE - Hospital Pedro Hispano; 🇵🇹 Senhora da Hora, Porto, 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; 🇵🇹 Lisboa, Portugal

Hospital Universitario Virgen de Las Nieves; 🇪🇸 Granada, Spain

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, Navarra, Spain

CHUVI - H.U. Alvaro Cunqueiro; 🇪🇸 Vigo, Pontevedra, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Universitario Vall d'Hebron - PPDS; 🇪🇸 Barcelona, Spain

Hospital Universitario Clínico San Cecilio; 🇪🇸 Granada, Spain

Hospital Vithas Granada; 🇪🇸 Granada, Spain

Klinik Lengg AG; 🇨🇭 Zürich, 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

University College Hospital; 🇬🇧 London, Middlesex, United Kingdom

John Radcliffe Hospital; 🇬🇧 Oxford, Oxfordshire, United Kingdom

University Hospital of Wales; 🇬🇧 Cardiff, South Glamorgan, United Kingdom

Royal Victoria Infirmary; 🇬🇧 Newcastle Upon Tyne, United Kingdom