Clinical trial NCT06132893: A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Focal Epilepsy
Keywords: Focal Epilepsy
Epilepsy
Seizure
Refractory Epilepsy
Partial Epilepsy
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-15
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in 28-day average seizure frequency
timeFrame: Baseline, Week 8 to Week 20
Secondary outcomes:
measure: Percentage of Participants with at at least 50% reduction in seizure frequency per month
timeFrame: Baseline, Week 8 to Week 20
measure: Change from Baseline in 28-day average seizure frequency during first month of treatment
timeFrame: Baseline, Week 8 to Week 12
measure: Percentage of Participants with at at least 75% reduction in seizure frequency per month
timeFrame: Baseline, Week 8 to Week 20
measure: Percentage of Participants with seizure freedom during DB Phase
timeFrame: Week 8 to Week 20
measure: Change from baseline in 7-day adjusted seizure frequency during first week of treatment
timeFrame: Baseline, Week 8 to Week 9
measure: Change from baseline in Patient Global Impression of Change (PGI-C)
timeFrame: Baseline, Week 20
measure: Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
timeFrame: Week 8 to Week 20
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Week 8 to Week 20
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Little Rock
country: United States
facility: Clinical Trials, Inc.
state: Arkansas
city: Rogers
country: United States
facility: WRN
state: Arkansas
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Palo Alto
country: United States
facility: Stanford Health Care
state: California
city: Pasadena
country: United States
facility: Profound Research LLC
state: California
city: Aurora
country: United States
facility: University of Colorado Anschultz Medical Campus
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine - Yale-New Haven Hospital
state: Connecticut
city: Boca Raton
country: United States
facility: EZR Research LLC
state: Florida
city: Bradenton
country: United States
facility: Nova Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: University of Florida (Jacksonville)
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Port Charlotte
country: United States
facility: Medsol Clinical Research Center
state: Florida
city: Tampa
country: United States
facility: Santos Research Center
state: Florida
city: Weston
country: United States
facility: Encore Medical Research of Weston LLC.
state: Florida
city: Winter Park
country: United States
facility: Pediatrix Medical Group of Florida
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience
state: Hawaii
city: Boise
country: United States
facility: Consultants in Epilepsy & Neurology, PLLC
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Elgin
country: United States
facility: Revive Research Institute, Inc.
state: Illinois
city: Ames
country: United States
facility: Accellacare
state: Iowa
city: Lexington
country: United States
facility: Bluegrass Epilepsy Research
state: Kentucky
city: Bethesda
country: United States
facility: MAESC
state: Maryland
city: Silver Spring
country: United States
facility: Javara
state: Maryland
city: Rochester Hills
country: United States
facility: Revive Research Institute, Inc.
state: Michigan
city: Roseville
country: United States
facility: Minnesota Epilepsy Group, P.A.
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: NEREG
state: New Jersey
city: Livingston
country: United States
facility: Inst of Neurology
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Hawthorne
country: United States
facility: BCHP
state: New York
city: New York
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Woodmere
country: United States
facility: Five Towns Neuroscience Research
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions
state: North Carolina
city: Mooresville
country: United States
facility: Accellacare
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist
state: North Carolina
city: Canton
country: United States
facility: NeuroScience Research Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: OSU
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Cypress
country: United States
facility: Clinical Research Solutions LLC
state: Texas
city: Dallas
country: United States
facility: Neurology Consultants of Dallas, PA
state: Texas
city: Fort Worth
country: United States
facility: Tarrant Neurology Consultants
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, Ltd
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Burlington
country: United States
facility: UVM MC
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctors Neurology Associates, LLC
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: STAT Research S.A.
state: Buenos Aires
city: Balvanera
country: Argentina
facility: Hospital General de Agudos Dr. José María Ramos Mejia
state: Ciudad Autónoma De BuenosAires
city: Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102
state: Ciudad Autónoma De BuenosAires
city: Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires
state: Ciudad Autónoma De BuenosAires
city: San Miguel de Tucumán
country: Argentina
facility: Investigaciones Sanatorio Del Sur
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
city: Córdoba
country: Argentina
facility: Instituto Privado Kremer
city: Córdoba
country: Argentina
facility: Conci Carpinella - Santa Rosa N° 748
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Linz - Med Campus III
state: Oberösterreich
city: Salzburg
country: Austria
facility: Christian Doppler-Klinik - Universitätsklinikum der PMU
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
city: Wien
country: Austria
facility: Medizinische Universitat Wien (Medical University of Vienna)
city: Edegem
country: Belgium
facility: UZ Antwerpen
state: Antwerpen
city: Anderlecht
country: Belgium
facility: Hôpital Erasme
state: Brussels
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
state: Brussels
city: Yvoir
country: Belgium
facility: CHU UCL Namur - Site Godinne
state: Namur
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Temuco
country: Chile
facility: Centro de especialidades médicas Vanguardia
state: Araucanía
city: Santiago
country: Chile
facility: Hospital Padre Hurtado
state: Región-MetropolitanadeSantiago
city: Santiago
country: Chile
facility: BIOCINETIC Ltda
state: Región-MetropolitanadeSantiago
city: Santiago
country: Chile
facility: Centro de Investigacion Clinica UC
state: Región-MetropolitanadeSantiago
city: Viña del Mar
country: Chile
facility: Instituto Neurologico Thalamus
state: Valparaíso
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Clinical Hospital Sveti duh
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb
state: Grad Zagreb
city: Rijeka
country: Croatia
facility: Clinical Hospital Center Rijeka - PPDS
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
state: Jihomoravský Kraj
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole
state: Praha, Hlavní Mesto
city: Strasbourg
country: France
facility: CHU de Strasbourg - Hôpital de Hautepierre
state: Bas-Rhin
city: Dijon
country: France
facility: CHU Dijon Bourgogne
state: Côte-d'Or
city: Toulouse
country: France
facility: CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
state: Haute-Garonne
city: Montpellier
country: France
facility: CHU de Montpellier- Hôpital Gui De Chauliac
state: Hérault
city: Tours
country: France
facility: CHRU de Tours - Hôpital Bretonneau
state: Indre-et-Loire
city: Nancy
country: France
facility: CHRU Nancy
state: Meurthe-et-Moselle
city: Lille Cedex
country: France
facility: CHU de Lille - Hopital Claude Huriez
state: Nord
city: Lyon
country: France
facility: Hospices Civils de Lyon - 59 Bd Pinel
state: Rhône
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
state: Baranya
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus
state: Hajdú-Bihar
city: Budapest
country: Hungary
facility: Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
city: Budapest
country: Hungary
facility: SE INK Juhasz Pal Epilepszia Központ
city: Heeze
country: Netherlands
facility: Kempenhaeghe - PPDS
state: Noord-Brabant
city: Heemstede
country: Netherlands
facility: Stichting Epilepsie Instellingen Nederland - Heemstede
state: Noord-Holland
city: Zwolle
country: Netherlands
facility: Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20
state: Overijssel
city: Wrocław
country: Poland
facility: Przychodnia VISTAMED
state: Dolnoslaskie
city: Lublin
country: Poland
facility: Clinical Best Solutions - Lublin
state: Lubelskie
city: Świdnik
country: Poland
facility: NZOZ IGNIS dr med. Alicja Lobinska
state: Lubelskie
city: Nowa Sól
country: Poland
facility: Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
state: Lubuskie
city: Łódź
country: Poland
facility: Santa Familia PTG Lodz
state: Lódzkie
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by PRATIA - PPDS
state: Mazowieckie
city: Warszawa
country: Poland
facility: Neurosphera SP. Z O.O
state: Mazowieckie
city: Warszawa
country: Poland
facility: Instytut Psychiatrii i Neurologii
state: Mazowieckie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Poznań
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
state: Wielkopolskie
city: Gdańsk
country: Poland
facility: Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6
city: Katowice
country: Poland
facility: Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44
city: Kraków
country: Poland
facility: Pratia MCM Kraków
city: Kraków
country: Poland
facility: LANDA Specjalistyczne Gabinety Lekarskie
city: Maribor
country: Slovenia
facility: University Clinical Centre Maribor
city: Cape Town
country: South Africa
facility: InnoMed Clinical Trial Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western Cape
city: Zürich
country: Switzerland
facility: Klinik Lengg AG
state: Zürich (de)
Study officials:
References: