RecruitingPhase 2Phase 3NCT06132893

A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

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

Sponsor

Biohaven Therapeutics Ltd.

Enrollment

390 participants

Start Date

Mar 14, 2024

Study Type

INTERVENTIONAL

Conditions

Focal Epilepsy

Summary

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BHV-7000, a drug called BHV-7000, and others for people with focal epilepsy. The study is currently recruiting participants at 124 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBHV-7000

BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily

DRUGBHV-7000

BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily

DRUGPlacebo

Matching placebo taken once daily

DRUGBHV-7000

BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily

DRUGPlacebo

Matching placebo taken once daily

Locations(124)

Barrow Neurological Institute

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

University of California, Los Angeles

Los Angeles, California, United States

Stanford Health Care

Palo Alto, California, United States

Profound Research LLC

Pasadena, California, United States

University of Colorado Anschultz Medical Campus

Aurora, Colorado, 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

University of Miami

Miami, Florida, United States

Floridian Research Institute

Miami, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Medsol Clinical Research Center

Port Charlotte, 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.

Elgin, Illinois, United States

Accellacare

Ames, Iowa, United States

Bluegrass Epilepsy Research

Lexington, Kentucky, United States

MAESC

Bethesda, Maryland, United States

Javara

Silver Spring, Maryland, United States

Revive Research Institute, Inc.

Rochester Hills, Michigan, United States

Minnesota Epilepsy Group, P.A.

Roseville, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, 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

BCHP

Hawthorne, New York, United States

Northwell Health

New York, New York, United States

Icahn School of Medicine at Mt. Sinai

New York, New York, United States

Stony Brook Medicine

Stony Brook, New York, United States

Five Towns Neuroscience Research

Woodmere, New York, 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

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, 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

Tarrant Neurology Consultants

Fort Worth, Texas, United States

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

UT Health San Antonio

San Antonio, Texas, United States

Road Runner Research, Ltd

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States

UVM MC

Burlington, Vermont, United States

University of Virginia

Charlottesville, 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 Province, Argentina

Sanatorio de la Trinidad - Mitre

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI

Buenos Aires, Argentina

Instituto Privado Kremer

Córdoba, Argentina

Conci Carpinella - Santa Rosa N° 748

Córdoba, Argentina

Kepler Universitätsklinikum Linz - Med Campus III

Linz, Upper Austria, Austria

Christian Doppler-Klinik - Universitätsklinikum der PMU

Salzburg, Austria

Universitätsklinikum St. Pölten

Sankt Pölten, Austria

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, Austria

UZ Antwerpen

Edegem, Antwerpen, Belgium

Hôpital Erasme

Anderlecht, Brussels Capital, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

CHU UCL Namur - Site Godinne

Yvoir, Namur, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

Centro de especialidades médicas Vanguardia

Temuco, Araucania, 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, Valparaiso, Chile

Clinical Hospital Sveti duh

Zagreb, City of Zagreb, Croatia

Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29

Zagreb, City of Zagreb, Croatia

Clinical Hospital Center Rijeka - PPDS

Rijeka, Croatia

Fakultni nemocnice v Motole

Prague, Praha, Hlavní Mesto, Czechia

Fakultni nemocnice u sv. Anny v Brne

Brno, South Moravian, Czechia

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, Nord, France

Hospices Civils de Lyon - 59 Bd Pinel

Lyon, Rhône, France

Hôpital Pontchaillou

Rennes, France

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

Kempenhaeghe - PPDS

Heeze, North Brabant, Netherlands

Stichting Epilepsie Instellingen Nederland - Heemstede

Heemstede, North Holland, Netherlands

Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20

Zwolle, Overijssel, Netherlands

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

Poznan, Greater Poland Voivodeship, Poland

Przychodnia VISTAMED

Wroclaw, Lower Silesian Voivodeship, Poland

Clinical Best Solutions - Lublin

Lublin, Lublin Voivodeship, Poland

NZOZ IGNIS dr med. Alicja Lobinska

Świdnik, Lublin Voivodeship, Poland

Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o

Nowa Sól, Lubusz Voivodeship, Poland

Santa Familia PTG Lodz

Lodz, Lódzkie, Poland

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship, Poland

Neurosphera SP. Z O.O

Warsaw, Masovian Voivodeship, Poland

Instytut Psychiatrii i Neurologii

Warsaw, Masovian Voivodeship, Poland

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, Poland

Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6

Gdansk, Poland

Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44

Katowice, Poland

Pratia MCM Kraków

Krakow, Poland

LANDA Specjalistyczne Gabinety Lekarskie

Krakow, Poland

University Clinical Centre Maribor

Maribor, Slovenia

InnoMed Clinical Trial Centre

Cape Town, Western Cape, South Africa

Groote Schuur Hospital

Cape Town, Western Cape, South Africa

Klinik Lengg AG

Zurich, Zürich (de), Switzerland

View Full Details on ClinicalTrials.gov

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NCT06132893

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