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NCT06132893PHASE2, PHASE3Recruiting

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

Biohaven Therapeutics Ltd.

Start Date

3/14/2024

Completion Date

12/1/2026

Summary

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

Detailed Description

This study has two parts, Part A and Part B. Part A is randomized 1:1:1 25 mg of BHV-7000, 50 mg of BHV-7000 or matching placebo. Part B is randomized 1:1 75mg BHV-7000 or matching placebo. Part B will start after Part A.

Eligibility Criteria

Age Range: 18 years to 75 years

Key Inclusion Criteria: 1. Male and Female participants 18 to 75 years of age at time of consent. 2. 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 3. 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. 4. Ability to keep accurate seizure diaries 5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total Key Exclusion Criteria: 1. History of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired consciousness for \> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure. 2. History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase. 3. Resection neurosurgery for seizures \<4 months prior to the screening visit. 4. Radiosurgery performed \<2 years prior to the screening visit. 5. Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms. 6. Any condition 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

Interventions

DRUG

BHV-7000

DRUG

BHV-7000

DRUG

Placebo

DRUG

BHV-7000

DRUG

Placebo

Interested in This Trial?

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Conditions

Focal Epilepsy

Locations

Barrow Neurological Institute

Phoenix, Arizona 85013

United States

Center for Neurosciences

Tucson, Arizona 85718

United States

Clinical Trials, Inc.

Little Rock, Arkansas 72205

United States

WRN

Rogers, Arkansas 72758

United States

University of California San Diego

La Jolla, California 92041

United States

University of California, Los Angeles

Los Angeles, California 90095

United States

Stanford Health Care

Palo Alto, California 94304

United States

Profound Research LLC

Pasadena, California 91105

United States

University of Colorado Anschultz Medical Campus

Aurora, Colorado 80045

United States

Yale School of Medicine - Yale-New Haven Hospital

New Haven, Connecticut 06519

United States

EZR Research LLC

Boca Raton, Florida 33486

United States

Nova Clinical Research, LLC

Bradenton, Florida 34209

United States

University of Florida (Jacksonville)

Jacksonville, Florida 32209

United States

University of Miami

Miami, Florida 33136

United States

Floridian Research Institute

Miami, Florida 33179

United States

AdventHealth Orlando

Orlando, Florida 32804

United States

Medsol Clinical Research Center

Port Charlotte, Florida 33952

United States

Santos Research Center

Tampa, Florida 33615

United States

Encore Medical Research of Weston LLC.

Weston, Florida 33331

United States

Pediatrix Medical Group of Florida

Winter Park, Florida 32789

United States

Augusta University

Augusta, Georgia 30912

United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii 96817

United States

Consultants in Epilepsy & Neurology, PLLC

Boise, Idaho 83702

United States

Northwestern University

Chicago, Illinois 60611

United States

Revive Research Institute, Inc.

Elgin, Illinois 60123

United States

Accellacare

Ames, Iowa 50010

United States

Bluegrass Epilepsy Research

Lexington, Kentucky 40504

United States

MAESC

Bethesda, Maryland 20817

United States

Javara

Silver Spring, Maryland 20901

United States

Revive Research Institute, Inc.

Rochester Hills, Michigan 48307

United States

Minnesota Epilepsy Group, P.A.

Roseville, Minnesota 55113

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

NEREG

Hackensack, New Jersey 07601

United States

Inst of Neurology

Livingston, New Jersey 07039

United States

Dent Neurosciences Research Center

Amherst, New York 14226

United States

BCHP

Hawthorne, New York 10532

United States

Northwell Health

New York, New York 10021

United States

Icahn School of Medicine at Mt. Sinai

New York, New York 10029

United States

Stony Brook Medicine

Stony Brook, New York 11794

United States

Five Towns Neuroscience Research

Woodmere, New York 11598

United States

OnSite Clinical Solutions

Charlotte, North Carolina 28211

United States

Accellacare

Mooresville, North Carolina 28117

United States

Wake Forest Baptist

Winston-Salem, North Carolina 27157

United States

NeuroScience Research Center

Canton, Ohio 44718

United States

University of Cincinnati

Cincinnati, Ohio 45267

United States

OSU

Columbus, Ohio 43214

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

UPMC

Pittsburgh, Pennsylvania 15213

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Clinical Research Solutions LLC

Cypress, Texas 77433

United States

Neurology Consultants of Dallas, PA

Dallas, Texas 75243

United States

Tarrant Neurology Consultants

Fort Worth, Texas 76104

United States

Michael E. DeBakey VA Medical Center

Houston, Texas 77030

United States

UT Health San Antonio

San Antonio, Texas 78229

United States

Road Runner Research, Ltd

San Antonio, Texas 78249

United States

University of Utah

Salt Lake City, Utah 84132

United States

UVM MC

Burlington, Vermont 05401

United States

University of Virginia

Charlottesville, Virginia 22903

United States

Henrico Doctors Neurology Associates, LLC

Richmond, Virginia 23235

United States

Carilion Clinic

Roanoke, Virginia 24011

United States

STAT Research S.A.

Ciudad Autónoma de Buenos Aires, Buenos Aires C1013AAB

Argentina

Hospital General de Agudos Dr. José María Ramos Mejia

Balvanera, Ciudad Autónoma de BuenosAires C1221ADC

Argentina

Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102

Buenos Aires, Ciudad Autónoma de BuenosAires C1431FWO

Argentina

Hospital Británico de Buenos Aires

Buenos Aires, Ciudad Autónoma de BuenosAires C1437JCH

Argentina

Investigaciones Sanatorio Del Sur

San Miguel de Tucumán, Tucumán Province T4000AXL

Argentina

Sanatorio de la Trinidad - Mitre

Buenos Aires, C1039AAO

Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH

Argentina

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

Buenos Aires, C1428AQK

Argentina

Instituto Privado Kremer

Córdoba, X5004AOA

Argentina

Conci Carpinella - Santa Rosa N° 748

Córdoba, X5008HHW

Argentina

Kepler Universitätsklinikum Linz - Med Campus III

Linz, Upper Austria 4020

Austria

Christian Doppler-Klinik - Universitätsklinikum der PMU

Salzburg, 5020

Austria

Universitätsklinikum St. Pölten

Sankt Pölten, 3100

Austria

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, 1090

Austria

UZ Antwerpen

Edegem, Antwerpen 2650

Belgium

Hôpital Erasme

Anderlecht, Brussels Capital 1070

Belgium

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital 1200

Belgium

CHU UCL Namur - Site Godinne

Yvoir, Namur 5530

Belgium

UZ Gent

Ghent, Oost-Vlaanderen 9000

Belgium

Centro de especialidades médicas Vanguardia

Temuco, Araucania 4780000

Chile

Hospital Padre Hurtado

Santiago, Región-MetropolitanadeSantiago 8260094

Chile

BIOCINETIC Ltda

Santiago, Región-MetropolitanadeSantiago 8320000

Chile

Centro de Investigacion Clinica UC

Santiago, Región-MetropolitanadeSantiago 8320000

Chile

Instituto Neurologico Thalamus

Viña del Mar, Valparaiso 2520021

Chile

Clinical Hospital Sveti duh

Zagreb, City of Zagreb 10000

Croatia

Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29

Zagreb, City of Zagreb 10000

Croatia

Clinical Hospital Center Rijeka - PPDS

Rijeka, 51000

Croatia

Fakultni nemocnice v Motole

Prague, Praha, Hlavní Mesto 150 06

Czechia

Fakultni nemocnice u sv. Anny v Brne

Brno, South Moravian 602 00

Czechia

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, Bas-Rhin 67000

France

CHU Dijon Bourgogne

Dijon, Côte-d'Or 21000

France

CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan

Toulouse, Haute-Garonne 31059

France

CHU de Montpellier- Hôpital Gui De Chauliac

Montpellier, Hérault 34295

France

CHRU de Tours - Hôpital Bretonneau

Tours, Indre-et-Loire 37000

France

CHRU Nancy

Nancy, Meurthe-et-Moselle 54000

France

CHU de Lille - Hopital Claude Huriez

Lille, Nord 59037

France

Hospices Civils de Lyon - 59 Bd Pinel

Lyon, Rhône 69003

France

Hôpital Pontchaillou

Rennes, 35033

France

Pécsi Tudományegyetem Klinikai Kozpont -Ret u.

Pécs, Baranya 7623

Hungary

Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus

Debrecen, Hajdú-Bihar 4031

Hungary

Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, 1106

Hungary

SE INK Juhasz Pal Epilepszia Központ

Budapest, 1145

Hungary

Kempenhaeghe - PPDS

Heeze, North Brabant 5591 VE

Netherlands

Stichting Epilepsie Instellingen Nederland - Heemstede

Heemstede, North Holland 2103 SW

Netherlands

Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20

Zwolle, Overijssel 8025 BV

Netherlands

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

Poznan, Greater Poland Voivodeship 60-702

Poland

Przychodnia VISTAMED

Wroclaw, Lower Silesian Voivodeship 53-149

Poland

Clinical Best Solutions - Lublin

Lublin, Lublin Voivodeship 20-078

Poland

NZOZ IGNIS dr med. Alicja Lobinska

Świdnik, Lublin Voivodeship 21-040

Poland

Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o

Nowa Sól, Lubusz Voivodeship 67-100

Poland

Santa Familia PTG Lodz

Lodz, Lódzkie 90-302

Poland

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship 02-172

Poland

Neurosphera SP. Z O.O

Warsaw, Masovian Voivodeship 02-829

Poland

Instytut Psychiatrii i Neurologii

Warsaw, Masovian Voivodeship 02-957

Poland

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

Gdansk, Pomeranian Voivodeship 80-546

Poland

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

Gdansk, 80-803

Poland

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

Katowice, 40-594

Poland

Pratia MCM Kraków

Krakow, 30-727

Poland

LANDA Specjalistyczne Gabinety Lekarskie

Krakow, 31-156

Poland

University Clinical Centre Maribor

Maribor, 2000

Slovenia

InnoMed Clinical Trial Centre

Cape Town, Western Cape 7530

South Africa

Groote Schuur Hospital

Cape Town, Western Cape 7700

South Africa

Klinik Lengg AG

Zurich, Zürich (de) 8008

Switzerland