A Phase 2/3 Multicenter, Randomization, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
Status: Recruiting
Location: See all (173) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male and Female participants 18 to 75 years of age at time of consent.
• Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.
• a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures with clinically observable signs and/or symptoms iii. Focal to bilateral tonic-clonic seizures
• Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
• Ability to keep accurate seizure diaries
• Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total
Locations
United States
Alabama
Accel Research
WITHDRAWN
Birmingham
Arkansas
Clinical Trials, Inc.
RECRUITING
Little Rock
Arizona
Onyx Clinical Trials
RECRUITING
Peoria
ARENSIA Exploratory Medicine
RECRUITING
Phoenix
University of Arizona / Banner University Medical Center Phoenix
RECRUITING
Phoenix
Xenoscience, Inc.
RECRUITING
Phoenix
California
Amicis Research Center
WITHDRAWN
Lancaster
Memorialcare Miller Children's & Women's Hospital Long Beach
WITHDRAWN
Long Beach
Tri Valley Neurology Medical Associates, Inc.
RECRUITING
Mission Hills
Stanford University
WITHDRAWN
Palo Alto
Profound Research LLC
RECRUITING
Poway
Colorado
Kaiser Permanente
WITHDRAWN
Aurora
Connecticut
UConn Health
RECRUITING
Farmington
Washington, D.c.
Children's National Medical Center
WITHDRAWN
Washington D.c.
Florida
EZR Research, LLC
WITHDRAWN
Boca Raton
Nova Clinical Research, LLC
RECRUITING
Bradenton
Las Mercedes Medical Research
RECRUITING
Hialeah
Coral Clinic Research
RECRUITING
Homestead
Dm Healthworks
WITHDRAWN
Kissimmee
Serenity Research Center
RECRUITING
Miami
Y&L Advance Health Care, Inc d/b/a Elite Clinical Research
RECRUITING
Miami
Comprehensive Neurology Clinic
RECRUITING
Orlando
Research Institute of Orlando
RECRUITING
Orlando
Panhandle Research & Medical Clinic
RECRUITING
Pensacola
Knight Neurology
RECRUITING
Rockledge
PENS
WITHDRAWN
Tampa
Encore Medical Research of Weston LLC.
RECRUITING
Weston
Georgia
Accelerated Clinical Trials, LLC
RECRUITING
Peachtree Corners
Kentucky
Bluegrass Epilepsy Research
RECRUITING
Lexington
Louisiana
DelRicht Research
RECRUITING
Baton Rouge
OLORMC
WITHDRAWN
Baton Rouge
Neurocare Of Louisiana
RECRUITING
Covington
DelRicht Research
RECRUITING
New Orleans
University Medical Center New Orleans
RECRUITING
New Orleans
LSU Health Shreveport
RECRUITING
Shreveport
Massachusetts
Boston Clinical Trials
RECRUITING
Boston
Boston Neuro Research
RECRUITING
South Dartmouth
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Michigan
SRI International
RECRUITING
Plymouth
Missouri
University of Missouri Health Care
RECRUITING
Columbia
North Carolina
UNC-Chapel Hill
WITHDRAWN
Chapel Hill
Nebraska
Somnos Clinical Research
RECRUITING
Lincoln
New Jersey
NEREG
RECRUITING
Hackensack
Tekton Research
RECRUITING
Marlboro
New York
Dent Neurosciences Research Center
RECRUITING
Amherst
Northwell Health
RECRUITING
Great Neck
Northwell Health Ped. Neurology
WITHDRAWN
New Hyde Park
NYU Langone Health
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Cincinatti Children's Hospital
WITHDRAWN
Cincinnati
Premier Health
RECRUITING
Dayton
Oregon
Oregon Neurology Associates
RECRUITING
Springfield
Pennsylvania
AHN
RECRUITING
Pittsburgh
South Carolina
MUSC
RECRUITING
Charleston
Tennessee
WR-ClinSearch
WITHDRAWN
Chattanooga
Le Bonheur Children's Hospital
RECRUITING
Memphis
Texas
Horizon Clinical Research Group
RECRUITING
Cypress
M3 Wake Research-Dallas
RECRUITING
Dallas
ANESC Research
RECRUITING
El Paso
Tarrant Neurology Associates
WITHDRAWN
Fort Worth
UTHealth Houston
RECRUITING
Houston
UTHSC
NOT_YET_RECRUITING
Houston
Stryde Research
RECRUITING
Plano
Utah
Intermountain Health
RECRUITING
Murray
Virginia
Medstar Health Research Institute
RECRUITING
Mclean
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Bedford Park
Royal Prince Alfred Hospital
RECRUITING
Camperdown
St Vincents Hospital Melbourne - PPDS
RECRUITING
Fitzroy
Austin Health
RECRUITING
Heidelberg
Royal Brisbane & Women's Hospital
RECRUITING
Herston
The Alfred Hospital
RECRUITING
Melbourne
Royal Melbourne Hospital
RECRUITING
Parkville
Prince of Wales Hospital
RECRUITING
Randwick
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Epilepsihospitalet Filadelfia
RECRUITING
Dianalund
Odense Universitetshospital
RECRUITING
Odense
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Kuopion yliopistollinen sairaala
RECRUITING
Kuopio
Tampereen yliopistollinen sairaala
RECRUITING
Tampere
Germany
Vivantes - Humboldt Klinikum
RECRUITING
Berlin
Epilepsieklinik Tabor
NOT_YET_RECRUITING
Bernau Bei Berlin
Krankenhaus Mara gGmbH
RECRUITING
Bielefeld
Universitätsklinikum Bonn
RECRUITING
Bonn
Universitätsklinikum Erlangen
RECRUITING
Erlangen
Universitätsklinikum Frankfurt
RECRUITING
Frankfurt
Universitätsklinikum Freiburg
RECRUITING
Freiburg Im Breisgau
Epilepsiezentrum Kork
RECRUITING
Kehl
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
RECRUITING
Marburg
LMU Klinikum der Universität München - Campus Großhadern
RECRUITING
München
Universitätsklinikum Münster
NOT_YET_RECRUITING
Münster
Klinikum Osnabrück GmbH
RECRUITING
Osnabrück
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
RECRUITING
Radeberg
Epilepsie-Zentrum Bodensee
RECRUITING
Ravensburg
Universitätsklinikum Ulm
RECRUITING
Ulm
Greece
University General Hospital of Alexandroupolis
RECRUITING
Alexandroupoli
University General Hospital ''ATTIKON''
RECRUITING
Chaïdári
University General Hospital of Ioannina
RECRUITING
Ioannina
AHEPA University General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Georgios Papanikolaou General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Hungary
Semmel Egyet Idegsebésze Neuro Klin
RECRUITING
Budapest
India
Nizam's Insti. of Medical Sciences
RECRUITING
Hyderabad
Mallikatta Neuro Centre
RECRUITING
Mangalore
Jaslok Hospital and Research
RECRUITING
Mumbai
Dr G M Taori Memorial CIIMS
RECRUITING
Nagpur
All India Institute of Medical Sciences (AIIMS)
RECRUITING
New Delhi
Italy
Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
RECRUITING
Ancona
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
RECRUITING
Baggiovara
AUSL di Bologna - Ospedale Bellaria
RECRUITING
Bologna
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
RECRUITING
Calambrone
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
RECRUITING
Catanzaro
Università degli Studi G. D'Annunzio Chieti-Pescara
RECRUITING
Chieti
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
RECRUITING
Genoa
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
RECRUITING
Milan
Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
Ospedale San Raffaele S.r.l. - PPDS
RECRUITING
Milan
AORN Antonio Cardarelli
RECRUITING
Naples
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
RECRUITING
Pavia
IRCCS Istituto Neurologico Mediterraneo Neuromed
RECRUITING
Pozzilli
Fondazione Policlinico Universitario A Gemelli-Rome
RECRUITING
Roma
Fondazione PTV Policlinico Tor Vergata
RECRUITING
Rome
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
RECRUITING
Rome
Azienda Ospedaliera Universitaria Integrata Di Verona
RECRUITING
Verona
Mexico
Clinstile, S.A. de C.V.
RECRUITING
Mexico City
Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
NOT_YET_RECRUITING
Mexico City
Accelerium, S. de R.L. de C.V. - PPDS
NOT_YET_RECRUITING
Monterrey
Axis Heilsa S. de R.L. de C.V.
RECRUITING
Obispado
Neurociencias Estudios Clinicos S.C.
RECRUITING
Sinaloa
Clinical Research Institute SC-Mexico
RECRUITING
Tlalnepantla
FAICIC S De RL De CV
RECRUITING
Veracruz
Poland
LANDA Specjalistyczne
RECRUITING
Krakow
MTZ Clinical Research
RECRUITING
Krakow
Pratia MCM Krakow
RECRUITING
Krakow
Neurosphera SP. Z O.O
RECRUITING
Warsaw
Premium Clinic Wrocław
RECRUITING
Wroclaw
Portugal
Centro Clínico Académico, Braga - Hospital de Braga
RECRUITING
Braga
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
RECRUITING
Coimbra
Hospital da Luz Torres de Lisboa
RECRUITING
Lisbon
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
RECRUITING
Lisbon
ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
RECRUITING
Santa Maria Da Feira
ULS de Matosinhos, EPE - Hospital Pedro Hispano
RECRUITING
Senhora Da Hora
Romania
Emergency University Hospital
RECRUITING
Bucharest
Targu-Mures Emergency Clinical County Hospital - Str. Gh. Marinescu nr.50
RECRUITING
Târgu Mureş
Slovakia
IN MEDIC, s.r.o.
RECRUITING
Bardejov
Kraskova 2636, Neurologické oddelenie
RECRUITING
Rimavská Sobota
Spain
Hospital Universitario Germans Trias i Pujol
RECRUITING
Badalona
Fundacio Assistencial Mutua de Terrassa
RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron - PPDS
RECRUITING
Barcelona
Hospital Universitario Clínico San Cecilio
RECRUITING
Granada
Hospital Universitario Virgen de Las Nieves
RECRUITING
Granada
Hospital Vithas Granada
RECRUITING
Granada
Hospital Universitario de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Blua Sanitas Valdebebas Hospital
NOT_YET_RECRUITING
Madrid
Hospital blua sanitas valdebebas
RECRUITING
Madrid
Hospital Ruber Internacional (Grupo Quironsalud)
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Regional Universitario de Malaga - Hospital General
RECRUITING
Málaga
Hospital Universitario de Navarra
RECRUITING
Pamplona
Centro de Neurologia Avanzada
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe de Valencia
RECRUITING
Valencia
Hospital Clinico Universitario de Valladolid
RECRUITING
Valladolid
CHUVI - H.U. Alvaro Cunqueiro
RECRUITING
Vigo
United Kingdom
University Hospital of Wales
RECRUITING
Cardiff
Queen Elizabeth University Hospital-PPDS
RECRUITING
Glasgow
The Walton Centre - PPDS
RECRUITING
Liverpool
King's College Hospital
RECRUITING
London
St Georges NHS Foundation Trust
RECRUITING
London
The Royal London Hospital
RECRUITING
London
Royal Victoria Infirmary
RECRUITING
Newcastle Upon Tyne
John Radcliffe Hospital
RECRUITING
Oxford
Salford Royal Hospital - PPDS
RECRUITING
Salford
Morriston Hospital
RECRUITING
Swansea
Contact Information
Primary
Chief Medical Officer
clinicaltrials@biohavenpharma.com
203-404-0410
Time Frame
Start Date: 2024-05-13
Estimated Completion Date: 2026-05
Participants
Target number of participants: 390
Treatments
Experimental: BHV-7000 50 mg
Experimental: BHV-7000 75 mg
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Biohaven Therapeutics Ltd.