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

NCT06132893 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: BHV7000-3022023-508539-30
• Study Type: interventional
• Target: 390
• Locations: 14 countries
• Sites: 124

Brief Summary

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

Conditions

Focal Epilepsy

Keywords

Focal Epilepsy; Epilepsy; Seizure; Refractory Epilepsy; Partial Epilepsy

Outcome Measures

Primary Outcomes (3)

• Part B: Change from Baseline in 28-day average seizure frequency

  To compare the efficacy of each of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 12-week double-blind treatment phase.

  Baseline, Week 8 to Week 20 of Part B

• Part A: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs

  To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.

  Week 8 to Week 20 of Part A

• Part A: Number of Participants With Clinically Significant Laboratory Abnormalities

  To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.

  Week 8 to Week 20 of Part A

Secondary Outcomes (8)

• Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month

  Baseline, Week 8 to Week 20 of Part B

• Part B: Change from Baseline in 28-day average seizure frequency during first month of treatment

  Baseline, Week 8 to Week 12 of Part B

• Part B: Percentage of Participants with at at least 75% reduction in seizure frequency per month

  Baseline, Week 8 to Week 20 of Part B

• Part B: Percentage of Participants with seizure freedom during DB Phase

  Week 8 to Week 20 of Part B

• Part B: Change from baseline in 7-day adjusted seizure frequency during first week of treatment

  Baseline, Week 8 to Week 9 of Part B

Study Arms (5)

BHV-7000 25 mg Part A

EXPERIMENTAL

Drug: BHV-7000

BHV-7000 50 mg Part A

EXPERIMENTAL

Drug: BHV-7000

Placebo Part A

PLACEBO COMPARATOR

Drug: Placebo

BHV-7000 75 mg Part B

EXPERIMENTAL

Drug: BHV-7000

Placebo Part B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BHV-7000 DRUG

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

BHV-7000 25 mg Part A

Placebo DRUG

Matching placebo taken once daily

Placebo Part A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biohaven Therapeutics Ltd.: lead

Study Sites (124)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

RECRUITING

Center for Neurosciences

Tucson, Arizona, 85718, United States

RECRUITING

Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States

RECRUITING

WRN

Rogers, Arkansas, 72758, United States

WITHDRAWN

University of California San Diego

La Jolla, California, 92041, United States

RECRUITING

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Stanford Health Care

Palo Alto, California, 94304, United States

RECRUITING

Profound Research LLC

Pasadena, California, 91105, United States

RECRUITING

University of Colorado Anschultz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Yale School of Medicine - Yale-New Haven Hospital

New Haven, Connecticut, 06519, United States

RECRUITING

EZR Research LLC

Boca Raton, Florida, 33486, United States

RECRUITING

Nova Clinical Research, LLC

Bradenton, Florida, 34209, United States

RECRUITING

University of Florida (Jacksonville)

Jacksonville, Florida, 32209, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Floridian Research Institute

Miami, Florida, 33179, United States

WITHDRAWN

AdventHealth Orlando

Orlando, Florida, 32804, United States

WITHDRAWN

Medsol Clinical Research Center

Port Charlotte, Florida, 33952, United States

RECRUITING

Santos Research Center

Tampa, Florida, 33615, United States

RECRUITING

Encore Medical Research of Weston LLC.

Weston, Florida, 33331, United States

RECRUITING

Pediatrix Medical Group of Florida

Winter Park, Florida, 32789, United States

WITHDRAWN

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

RECRUITING

Consultants in Epilepsy & Neurology, PLLC

Boise, Idaho, 83702, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Revive Research Institute, Inc.

Elgin, Illinois, 60123, United States

RECRUITING

Accellacare

Ames, Iowa, 50010, United States

WITHDRAWN

Bluegrass Epilepsy Research

Lexington, Kentucky, 40504, United States

RECRUITING

MAESC

Bethesda, Maryland, 20817, United States

RECRUITING

Javara

Silver Spring, Maryland, 20901, United States

COMPLETED

Revive Research Institute, Inc.

Rochester Hills, Michigan, 48307, United States

WITHDRAWN

Minnesota Epilepsy Group, P.A.

Roseville, Minnesota, 55113, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

NEREG

Hackensack, New Jersey, 07601, United States

RECRUITING

Inst of Neurology

Livingston, New Jersey, 07039, United States

RECRUITING

Dent Neurosciences Research Center

Amherst, New York, 14226, United States

RECRUITING

BCHP

Hawthorne, New York, 10532, United States

RECRUITING

Northwell Health

New York, New York, 10021, United States

RECRUITING

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

WITHDRAWN

Stony Brook Medicine

Stony Brook, New York, 11794, United States

RECRUITING

Five Towns Neuroscience Research

Woodmere, New York, 11598, United States

RECRUITING

OnSite Clinical Solutions

Charlotte, North Carolina, 28211, United States

WITHDRAWN

Accellacare

Mooresville, North Carolina, 28117, United States

WITHDRAWN

Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

NeuroScience Research Center

Canton, Ohio, 44718, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

OSU

Columbus, Ohio, 43214, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

UPMC

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Clinical Research Solutions LLC

Cypress, Texas, 77433, United States

WITHDRAWN

Neurology Consultants of Dallas, PA

Dallas, Texas, 75243, United States

RECRUITING

Tarrant Neurology Consultants

Fort Worth, Texas, 76104, United States

NOT YET RECRUITING

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

WITHDRAWN

UT Health San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Road Runner Research, Ltd

San Antonio, Texas, 78249, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

UVM MC

Burlington, Vermont, 05401, United States

WITHDRAWN

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Henrico Doctors Neurology Associates, LLC

Richmond, Virginia, 23235, United States

RECRUITING

Carilion Clinic

Roanoke, Virginia, 24011, United States

RECRUITING

STAT Research S.A.

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1013AAB, Argentina

RECRUITING

Hospital General de Agudos Dr. José María Ramos Mejia

Balvanera, Ciudad Autónoma de BuenosAires, C1221ADC, Argentina

RECRUITING

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

Buenos Aires, Ciudad Autónoma de BuenosAires, C1431FWO, Argentina

RECRUITING

Hospital Británico de Buenos Aires

Buenos Aires, Ciudad Autónoma de BuenosAires, C1437JCH, Argentina

RECRUITING

Investigaciones Sanatorio Del Sur

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

RECRUITING

Sanatorio de la Trinidad - Mitre

Buenos Aires, C1039AAO, Argentina

RECRUITING

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

RECRUITING

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

Buenos Aires, C1428AQK, Argentina

RECRUITING

Instituto Privado Kremer

Córdoba, X5004AOA, Argentina

RECRUITING

Conci Carpinella - Santa Rosa N° 748

Córdoba, X5008HHW, Argentina

RECRUITING

Kepler Universitätsklinikum Linz - Med Campus III

Linz, Upper Austria, 4020, Austria

RECRUITING

Christian Doppler-Klinik - Universitätsklinikum der PMU

Salzburg, 5020, Austria

RECRUITING

Universitätsklinikum St. Pölten

Sankt Pölten, 3100, Austria

RECRUITING

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, 1090, Austria

RECRUITING

UZ Antwerpen

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Hôpital Erasme

Anderlecht, Brussels Capital, 1070, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

CHU UCL Namur - Site Godinne

Yvoir, Namur, 5530, Belgium

RECRUITING

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Centro de especialidades médicas Vanguardia

Temuco, Región de la Araucanía, 4780000, Chile

RECRUITING

Instituto Neurologico Thalamus

Viña del Mar, Región de Valparaíso, 2520021, Chile

RECRUITING

Hospital Padre Hurtado

Santiago, Región-MetropolitanadeSantiago, 8260094, Chile

RECRUITING

BIOCINETIC Ltda

Santiago, Región-MetropolitanadeSantiago, 8320000, Chile

RECRUITING

Centro de Investigacion Clinica UC

Santiago, Región-MetropolitanadeSantiago, 8320000, Chile

RECRUITING

Clinical Hospital Sveti duh

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

Clinical Hospital Center Rijeka - PPDS

Rijeka, 51000, Croatia

RECRUITING

Fakultni nemocnice v Motole

Prague, Praha, Hlavní Mesto, 150 06, Czechia

RECRUITING

Fakultni nemocnice u sv. Anny v Brne

Brno, South Moravian, 602 00, Czechia

RECRUITING

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, Bas-Rhin, 67000, France

NOT YET RECRUITING

CHU Dijon Bourgogne

Dijon, Côte-d'Or, 21000, France

RECRUITING

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

Toulouse, Haute-Garonne, 31059, France

RECRUITING

CHU de Montpellier- Hôpital Gui De Chauliac

Montpellier, Hérault, 34295, France

RECRUITING

CHRU de Tours - Hôpital Bretonneau

Tours, Indre-et-Loire, 37000, France

RECRUITING

CHRU Nancy

Nancy, Meurthe-et-Moselle, 54000, France

RECRUITING

CHU de Lille - Hopital Claude Huriez

Lille, Nord, 59037, France

RECRUITING

Hospices Civils de Lyon - 59 Bd Pinel

Lyon, Rhône, 69003, France

RECRUITING

Hôpital Pontchaillou

Rennes, 35033, France

RECRUITING

Pécsi Tudományegyetem Klinikai Kozpont -Ret u.

Pécs, Baranya, 7623, Hungary

RECRUITING

Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus

Debrecen, Hajdú-Bihar, 4031, Hungary

RECRUITING

Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, 1106, Hungary

RECRUITING

SE INK Juhasz Pal Epilepszia Központ

Budapest, 1145, Hungary

NOT YET RECRUITING

Kempenhaeghe - PPDS

Heeze, North Brabant, 5591 VE, Netherlands

RECRUITING

Stichting Epilepsie Instellingen Nederland - Heemstede

Heemstede, North Holland, 2103 SW, Netherlands

RECRUITING

Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20

Zwolle, Overijssel, 8025 BV, Netherlands

RECRUITING

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

Poznan, Greater Poland Voivodeship, 60-702, Poland

RECRUITING

Przychodnia VISTAMED

Wroclaw, Lower Silesian Voivodeship, 53-149, Poland

RECRUITING

Clinical Best Solutions - Lublin

Lublin, Lublin Voivodeship, 20-078, Poland

RECRUITING

NZOZ IGNIS dr med. Alicja Lobinska

Świdnik, Lublin Voivodeship, 21-040, Poland

RECRUITING

Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

RECRUITING

Santa Familia PTG Lodz

Lodz, Lódzkie, 90-302, Poland

RECRUITING

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship, 02-172, Poland

RECRUITING

Neurosphera SP. Z O.O

Warsaw, Masovian Voivodeship, 02-829, Poland

RECRUITING

Instytut Psychiatrii i Neurologii

Warsaw, Masovian Voivodeship, 02-957, Poland

RECRUITING

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

Gdansk, Pomeranian Voivodeship, 80-546, Poland

RECRUITING

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

Gdansk, 80-803, Poland

RECRUITING

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

Katowice, 40-594, Poland

RECRUITING

Pratia MCM Kraków

Krakow, 30-727, Poland

RECRUITING

LANDA Specjalistyczne Gabinety Lekarskie

Krakow, 31-156, Poland

RECRUITING

University Clinical Centre Maribor

Maribor, 2000, Slovenia

RECRUITING

InnoMed Clinical Trial Centre

Cape Town, Western Cape, 7530, South Africa

RECRUITING

Groote Schuur Hospital

Cape Town, Western Cape, 7700, South Africa

RECRUITING

Klinik Lengg AG

Zurich, Zürich (de), 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy; Seizures; Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chief Medical Officer

CONTACT

203-404-0410; clinicaltrials@biohavenpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: March 14, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

CR (3); CZ (2); FR (9); ZA (2); CH (1); AU (4); PL (14); SL (1); AR (10); BE (5); CL (5); US (61); NL (3); HU (4)