A Phase 2/3 Multicenter, Randomized, 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 (123) 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 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
Arkansas
Clinical Trials, Inc.
RECRUITING
Little Rock
WRN
RECRUITING
Rogers
Arizona
Barrow Neurological Institute
RECRUITING
Phoenix
Center for Neurosciences
RECRUITING
Tucson
California
University of California San Diego
RECRUITING
La Jolla
University of California, Los Angeles
RECRUITING
Los Angeles
Stanford Health Care
RECRUITING
Palo Alto
Profound Research LLC
RECRUITING
Pasadena
Colorado
University of Colorado Anschultz Medical Campus
RECRUITING
Aurora
Connecticut
Yale School of Medicine - Yale-New Haven Hospital
RECRUITING
New Haven
Florida
EZR Research LLC
RECRUITING
Boca Raton
Nova Clinical Research, LLC
RECRUITING
Bradenton
University of Florida (Jacksonville)
RECRUITING
Jacksonville
Floridian Research Institute
RECRUITING
Miami
University of Miami
RECRUITING
Miami
AdventHealth Orlando
RECRUITING
Orlando
Medsol Clinical Research Center
RECRUITING
Port Charlotte
Santos Research Center
RECRUITING
Tampa
Encore Medical Research of Weston LLC.
RECRUITING
Weston
Pediatrix Medical Group of Florida
WITHDRAWN
Winter Park
Georgia
Augusta University
RECRUITING
Augusta
Hawaii
Hawaii Pacific Neuroscience
RECRUITING
Honolulu
Iowa
Accellacare
RECRUITING
Ames
Idaho
Consultants in Epilepsy & Neurology, PLLC
RECRUITING
Boise
Illinois
Northwestern University
RECRUITING
Chicago
Revive Research Institute, Inc.
RECRUITING
Elgin
Kentucky
Bluegrass Epilepsy Research
RECRUITING
Lexington
Maryland
MAESC
RECRUITING
Bethesda
Javara
COMPLETED
Silver Spring
Michigan
Revive Research Institute, Inc.
WITHDRAWN
Rochester Hills
Minnesota
Minnesota Epilepsy Group, P.A.
RECRUITING
Roseville
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
OnSite Clinical Solutions
WITHDRAWN
Charlotte
Accellacare
RECRUITING
Mooresville
Wake Forest Baptist
RECRUITING
Winston-salem
New Jersey
NEREG
RECRUITING
Hackensack
Inst of Neurology
RECRUITING
Livingston
New York
Dent Neurosciences Research Center
RECRUITING
Amherst
BCHP
RECRUITING
Hawthorne
Icahn School of Medicine at Mt. Sinai
WITHDRAWN
New York
Northwell Health
RECRUITING
New York
Stony Brook Medicine
RECRUITING
Stony Brook
Five Towns Neuroscience Research
RECRUITING
Woodmere
Ohio
NeuroScience Research Center
RECRUITING
Canton
University of Cincinnati
RECRUITING
Cincinnati
OSU
RECRUITING
Columbus
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
UPMC
NOT_YET_RECRUITING
Pittsburgh
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Clinical Research Solutions LLC
WITHDRAWN
Cypress
Neurology Consultants of Dallas, PA
RECRUITING
Dallas
Tarrant Neurology Consultants
NOT_YET_RECRUITING
Fort Worth
Michael E. DeBakey VA Medical Center
RECRUITING
Houston
Road Runner Research, Ltd
RECRUITING
San Antonio
UT Health San Antonio
RECRUITING
San Antonio
Utah
University of Utah
RECRUITING
Salt Lake City
Virginia
University of Virginia
RECRUITING
Charlottesville
Henrico Doctors Neurology Associates, LLC
RECRUITING
Richmond
Carilion Clinic
RECRUITING
Roanoke
Vermont
UVM MC
WITHDRAWN
Burlington
Other Locations
Argentina
Hospital General de Agudos Dr. José María Ramos Mejia
RECRUITING
Balvanera
Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102
RECRUITING
Buenos Aires
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
NOT_YET_RECRUITING
Buenos Aires
Hospital Británico de Buenos Aires
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
STAT Research S.A.
RECRUITING
Ciudad Autónoma De Buenos Aires
Conci Carpinella - Santa Rosa N° 748
RECRUITING
Córdoba
Instituto Privado Kremer
RECRUITING
Córdoba
Investigaciones Sanatorio Del Sur
RECRUITING
San Miguel De Tucumán
Austria
Kepler Universitätsklinikum Linz - Med Campus III
RECRUITING
Linz
Christian Doppler-Klinik - Universitätsklinikum der PMU
RECRUITING
Salzburg
Universitätsklinikum St. Pölten
RECRUITING
Sankt Pölten
Medizinische Universitat Wien (Medical University of Vienna)
RECRUITING
Vienna
Belgium
Hôpital Erasme
RECRUITING
Anderlecht
Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
UZ Antwerpen
RECRUITING
Edegem
UZ Gent
RECRUITING
Ghent
CHU UCL Namur - Site Godinne
RECRUITING
Yvoir
Chile
BIOCINETIC Ltda
RECRUITING
Santiago
Centro de Investigacion Clinica UC
RECRUITING
Santiago
Hospital Padre Hurtado
RECRUITING
Santiago
Centro de especialidades médicas Vanguardia
RECRUITING
Temuco
Instituto Neurologico Thalamus
RECRUITING
Viña Del Mar
Croatia
Clinical Hospital Center Rijeka - PPDS
RECRUITING
Rijeka
Clinical Hospital Dubrava
NOT_YET_RECRUITING
Zagreb
Clinical Hospital Sveti duh
RECRUITING
Zagreb
Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29
RECRUITING
Zagreb
Klinicki bolnicki centar Zagreb
NOT_YET_RECRUITING
Zagreb
France
CHU Dijon Bourgogne
RECRUITING
Dijon
CHU de Lille - Hopital Claude Huriez
RECRUITING
Lille
Hospices Civils de Lyon - 59 Bd Pinel
RECRUITING
Lyon
CHU de Montpellier- Hôpital Gui De Chauliac
RECRUITING
Montpellier
CHRU Nancy
RECRUITING
Nancy
Hôpital Pontchaillou
RECRUITING
Rennes
CHU de Strasbourg - Hôpital de Hautepierre
NOT_YET_RECRUITING
Strasbourg
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
RECRUITING
Toulouse
CHRU de Tours - Hôpital Bretonneau
RECRUITING
Tours
Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
RECRUITING
Budapest
SE INK Juhasz Pal Epilepszia Központ
NOT_YET_RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus
RECRUITING
Debrecen
Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
RECRUITING
Pécs
Netherlands
Stichting Epilepsie Instellingen Nederland - Heemstede
RECRUITING
Heemstede
Kempenhaeghe - PPDS
RECRUITING
Heeze
Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20
RECRUITING
Zwolle
Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
RECRUITING
Gdansk
Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6
RECRUITING
Gdansk
Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44
RECRUITING
Katowice
LANDA Specjalistyczne Gabinety Lekarskie
RECRUITING
Krakow
Pratia MCM Kraków
RECRUITING
Krakow
Santa Familia PTG Lodz
RECRUITING
Lodz
Clinical Best Solutions - Lublin
RECRUITING
Lublin
Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
RECRUITING
Nowa Sól
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
RECRUITING
Poznan
NZOZ IGNIS dr med. Alicja Lobinska
RECRUITING
Świdnik
Instytut Psychiatrii i Neurologii
RECRUITING
Warsaw
MTZ Clinical Research Powered by PRATIA - PPDS
RECRUITING
Warsaw
Neurosphera SP. Z O.O
RECRUITING
Warsaw
Przychodnia VISTAMED
RECRUITING
Wroclaw
Slovenia
University Clinical Centre Maribor
RECRUITING
Maribor
South Africa
Groote Schuur Hospital
RECRUITING
Cape Town
InnoMed Clinical Trial Centre
RECRUITING
Cape Town
Switzerland
Klinik Lengg AG
RECRUITING
Zurich
Contact Information
Primary
Chief Medical Officer
clinicaltrials@biohavenpharma.com
203-404-0410
Time Frame
Start Date: 2024-03-14
Estimated Completion Date: 2026-12
Participants
Target number of participants: 390
Treatments
Experimental: BHV-7000 25 mg
Experimental: BHV-7000 50 mg
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Biohaven Therapeutics Ltd.