A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy | NCT06132893 | Trialant

A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy | NCT06132893 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Key Inclusion Criteria:

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

Key Exclusion Criteria:

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.

History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.

Resection neurosurgery for seizures <4 months prior to the screening visit.

Radiosurgery performed <2 years prior to the screening visit.

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.

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

Barrow Neurological InstituteRecruiting

Phoenix, Arizona 85013, United States

Caitlin GoodmanContact

Caitlin.Goodman@CommonSpirit.org602-406-6262

Center for NeurosciencesRecruiting

Tucson, Arizona 85718, United States

Clinical Trials, Inc.Recruiting

Little Rock, Arkansas 72205, United States

WRNWithdrawn

Rogers, Arkansas 72758, United States

University of California San DiegoRecruiting

La Jolla, California 92041, United States

University of California, Los AngelesRecruiting

Los Angeles, California 90095, United States

Stanford Health CareRecruiting

Palo Alto, California 94304, United States

Profound Research LLCCompleted

Pasadena, California 91105, United States

University of Colorado Anschultz Medical CampusRecruiting

Aurora, Colorado 80045, United States

Yale School of Medicine - Yale-New Haven HospitalRecruiting

New Haven, Connecticut 06519, United States

EZR Research LLCCompleted

Boca Raton, Florida 33486, United States

Nova Clinical Research, LLCRecruiting

Bradenton, Florida 34209, United States

University of Florida (Jacksonville)Recruiting

Jacksonville, Florida 32209, United States

University of MiamiRecruiting

Miami, Florida 33136, United States

Floridian Research InstituteWithdrawn

Miami, Florida 33179, United States

AdventHealth OrlandoWithdrawn

Orlando, Florida 32804, United States

Medsol Clinical Research CenterRecruiting

Port Charlotte, Florida 33952, United States

Santos Research CenterRecruiting

Tampa, Florida 33615, United States

Encore Medical Research of Weston LLC.Recruiting

Weston, Florida 33331, United States

Pediatrix Medical Group of FloridaWithdrawn

Winter Park, Florida 32789, United States

Augusta UniversityRecruiting

Augusta, Georgia 30912, United States

Hawaii Pacific NeuroscienceRecruiting

Honolulu, Hawaii 96817, United States

Consultants in Epilepsy & Neurology, PLLCRecruiting

Boise, Idaho 83702, United States

Northwestern UniversityRecruiting

Chicago, Illinois 60611, United States

Revive Research Institute, Inc.Completed

Elgin, Illinois 60123, United States

AccellacareWithdrawn

Ames, Iowa 50010, United States

Bluegrass Epilepsy ResearchRecruiting

Lexington, Kentucky 40504, United States

MAESCRecruiting

Bethesda, Maryland 20817, United States

JavaraCompleted

Silver Spring, Maryland 20901, United States

Revive Research Institute, Inc.Withdrawn

Rochester Hills, Michigan 48307, United States

Minnesota Epilepsy Group, P.A.Recruiting

Roseville, Minnesota 55113, United States

Washington University School of MedicineRecruiting

St Louis, Missouri 63110, United States

NEREGRecruiting

Hackensack, New Jersey 07601, United States

Inst of NeurologyRecruiting

Livingston, New Jersey 07039, United States

Dent Neurosciences Research CenterRecruiting

Amherst, New York 14226, United States

BCHPRecruiting

Hawthorne, New York 10532, United States

Northwell HealthRecruiting

New York, New York 10021, United States

Icahn School of Medicine at Mt. SinaiWithdrawn

New York, New York 10029, United States

Stony Brook MedicineRecruiting

Stony Brook, New York 11794, United States

Five Towns Neuroscience ResearchRecruiting

Woodmere, New York 11598, United States

OnSite Clinical SolutionsWithdrawn

Charlotte, North Carolina 28211, United States

AccellacareWithdrawn

Mooresville, North Carolina 28117, United States

Wake Forest BaptistRecruiting

Winston-Salem, North Carolina 27157, United States

NeuroScience Research CenterRecruiting

Canton, Ohio 44718, United States

University of CincinnatiRecruiting

Cincinnati, Ohio 45267, United States

OSURecruiting

Columbus, Ohio 43214, United States

University of PennsylvaniaRecruiting

Philadelphia, Pennsylvania 19104, United States

Thomas Jefferson UniversityRecruiting

Philadelphia, Pennsylvania 19107, United States

UPMCRecruiting

Pittsburgh, Pennsylvania 15213, United States

Vanderbilt University Medical CenterRecruiting

Nashville, Tennessee 37232, United States

Clinical Research Solutions LLCWithdrawn

Cypress, Texas 77433, United States

Neurology Consultants of Dallas, PARecruiting

Dallas, Texas 75243, United States

Tarrant Neurology ConsultantsNot yet recruiting

Fort Worth, Texas 76104, United States

Michael E. DeBakey VA Medical CenterWithdrawn

Houston, Texas 77030, United States

UT Health San AntonioRecruiting

San Antonio, Texas 78229, United States

Road Runner Research, LtdRecruiting

San Antonio, Texas 78249, United States

University of UtahRecruiting

Salt Lake City, Utah 84132, United States

UVM MCWithdrawn

Burlington, Vermont 05401, United States

University of VirginiaRecruiting

Charlottesville, Virginia 22903, United States

Henrico Doctors Neurology Associates, LLCRecruiting

Richmond, Virginia 23235, United States

Carilion ClinicRecruiting

Roanoke, Virginia 24011, United States

STAT Research S.A.Recruiting

Ciudad Autónoma de Buenos Aires, Buenos Aires C1013AAB, Argentina

Hospital General de Agudos Dr. José María Ramos MejiaRecruiting

Balvanera, Ciudad Autónoma de BuenosAires C1221ADC, Argentina

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

Buenos Aires, Ciudad Autónoma de BuenosAires C1431FWO, Argentina

Hospital Británico de Buenos AiresRecruiting

Buenos Aires, Ciudad Autónoma de BuenosAires C1437JCH, Argentina

Investigaciones Sanatorio Del SurRecruiting

San Miguel de Tucumán, Tucumán Province T4000AXL, Argentina

Sanatorio de la Trinidad - MitreRecruiting

Buenos Aires, C1039AAO, Argentina

Hospital Italiano de Buenos AiresRecruiting

Buenos Aires, C1181ACH, Argentina

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

Buenos Aires, C1428AQK, Argentina

Instituto Privado KremerRecruiting

Córdoba, X5004AOA, Argentina

Conci Carpinella - Santa Rosa N° 748Recruiting

Córdoba, X5008HHW, Argentina

Kepler Universitätsklinikum Linz - Med Campus IIIRecruiting

Linz, Upper Austria 4020, Austria

Christian Doppler-Klinik - Universitätsklinikum der PMURecruiting

Salzburg, 5020, Austria

Universitätsklinikum St. PöltenRecruiting

Sankt Pölten, 3100, Austria

Medizinische Universitat Wien (Medical University of Vienna)Recruiting

Vienna, 1090, Austria

UZ AntwerpenRecruiting

Edegem, Antwerpen 2650, Belgium

Hôpital ErasmeRecruiting

Anderlecht, Brussels Capital 1070, Belgium

Cliniques Universitaires Saint-LucRecruiting

Brussels, Brussels Capital 1200, Belgium

CHU UCL Namur - Site GodinneRecruiting

Yvoir, Namur 5530, Belgium

UZ GentRecruiting

Ghent, Oost-Vlaanderen 9000, Belgium

Centro de especialidades médicas VanguardiaRecruiting

Temuco, Araucania 4780000, Chile

Hospital Padre HurtadoRecruiting

Santiago, Región-MetropolitanadeSantiago 8260094, Chile

BIOCINETIC LtdaRecruiting

Santiago, Región-MetropolitanadeSantiago 8320000, Chile

Centro de Investigacion Clinica UCRecruiting

Santiago, Región-MetropolitanadeSantiago 8320000, Chile

Instituto Neurologico ThalamusRecruiting

Viña del Mar, Valparaiso 2520021, Chile

Clinical Hospital Sveti duhWithdrawn

Zagreb, City of Zagreb 10000, Croatia

Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29Withdrawn

Zagreb, City of Zagreb 10000, Croatia

Clinical Hospital Center Rijeka - PPDSWithdrawn

Rijeka, 51000, Croatia

Fakultni nemocnice v MotoleRecruiting

Prague, Praha, Hlavní Mesto 150 06, Czechia

Fakultni nemocnice u sv. Anny v BrneRecruiting

Brno, South Moravian 602 00, Czechia

CHU de Strasbourg - Hôpital de HautepierreNot yet recruiting

Strasbourg, Bas-Rhin 67000, France

CHU Dijon BourgogneRecruiting

Dijon, Côte-d'Or 21000, France

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

Toulouse, Haute-Garonne 31059, France

CHU de Montpellier- Hôpital Gui De ChauliacRecruiting

Montpellier, Hérault 34295, France

CHRU de Tours - Hôpital BretonneauRecruiting

Tours, Indre-et-Loire 37000, France

CHRU NancyRecruiting

Nancy, Meurthe-et-Moselle 54000, France

CHU de Lille - Hopital Claude HuriezCompleted

Lille, Nord 59037, France

Hospices Civils de Lyon - 59 Bd PinelRecruiting

Lyon, Rhône 69003, France

Hôpital PontchaillouRecruiting

Rennes, 35033, France

Pécsi Tudományegyetem Klinikai Kozpont -Ret u.Recruiting

Pécs, Baranya 7623, Hungary

Debreceni Egyetem Klinikai Kozpont Kenezy Gyula CampusRecruiting

Debrecen, Hajdú-Bihar 4031, Hungary

Budapesti Bajcsy-Zsilinszky Korhaz es RendelointezetRecruiting

Budapest, 1106, Hungary

SE INK Juhasz Pal Epilepszia KözpontNot yet recruiting

Budapest, 1145, Hungary

Kempenhaeghe - PPDSRecruiting

Heeze, North Brabant 5591 VE, Netherlands

Stichting Epilepsie Instellingen Nederland - HeemstedeRecruiting

Heemstede, North Holland 2103 SW, Netherlands

Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20Recruiting

Zwolle, Overijssel 8025 BV, Netherlands

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

Poznan, Greater Poland Voivodeship 60-702, Poland

Przychodnia VISTAMEDWithdrawn

Wroclaw, Lower Silesian Voivodeship 53-149, Poland

Clinical Best Solutions - LublinRecruiting

Lublin, Lublin Voivodeship 20-078, Poland

NZOZ IGNIS dr med. Alicja LobinskaRecruiting

Świdnik, Lublin Voivodeship 21-040, Poland

Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.oRecruiting

Nowa Sól, Lubusz Voivodeship 67-100, Poland

Santa Familia PTG LodzRecruiting

Lodz, Lódzkie 90-302, Poland

MTZ Clinical Research Powered by PRATIA - PPDSRecruiting

Warsaw, Masovian Voivodeship 02-172, Poland

Neurosphera SP. Z O.ORecruiting

Warsaw, Masovian Voivodeship 02-829, Poland

Instytut Psychiatrii i NeurologiiRecruiting

Warsaw, Masovian Voivodeship 02-957, Poland

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

Gdansk, Pomeranian Voivodeship 80-546, Poland

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

Gdansk, 80-803, Poland

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

Katowice, 40-594, Poland

Pratia MCM KrakówRecruiting

Krakow, 30-727, Poland

LANDA Specjalistyczne Gabinety LekarskieRecruiting

Krakow, 31-156, Poland

University Clinical Centre MariborRecruiting

Maribor, 2000, Slovenia

InnoMed Clinical Trial CentreWithdrawn

Cape Town, Western Cape 7530, South Africa

Groote Schuur HospitalWithdrawn

Cape Town, Western Cape 7700, South Africa

Klinik Lengg AGRecruiting

Zurich, Zürich (de) 8008, Switzerland