Clinical trial NCT06309966: Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Official title: A Phase 2/3 Multicenter, Randomization, 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: 2024-03-13
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 with clinically observable signs and/or symptoms 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 16
Secondary outcomes:
measure: Percentage of Participants with at at least 50% reduction in seizure frequency per month
timeFrame: Baseline, Week 8 to Week 16
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 16
measure: Percentage of Participants with seizure freedom during DB Phase
timeFrame: Week 8 to Week 16
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 16
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 16
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Week 8 to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research
state: Alabama
city: Phoenix
country: United States
facility: Xenoscience, Inc.
state: Arizona
city: Phoenix
country: United States
facility: ARENSIA Exploratory Medicine
state: Arizona
city: Lancaster
country: United States
facility: Amicis Research Center
state: California
city: Long Beach
country: United States
facility: Memorialcare Miller Children's & Women's Hospital Long Beach
state: California
city: Poway
country: United States
facility: Profound Research LLC
state: California
city: Aurora
country: United States
facility: Kaiser Permanente
state: Colorado
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Kissimmee
country: United States
facility: Dm Healthworks
state: Florida
city: Miami
country: United States
facility: Y&L Advance Health Care, Inc d/b/a Elite Clinical Research
state: Florida
city: Miami
country: United States
facility: Serenity Research Center
state: Florida
city: Orlando
country: United States
facility: Research Institute of Orlando
state: Florida
city: Orlando
country: United States
facility: Comprehensive Neurology Clinic
state: Florida
city: Rockledge
country: United States
facility: Knight Neurology
state: Florida
city: Tampa
country: United States
facility: PENS
state: Florida
city: Baton Rouge
country: United States
facility: OLORMC
state: Louisiana
city: Baton Rouge
country: United States
facility: DelRicht Research
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Lincoln
country: United States
facility: Somnos Clinical Research
state: Nebraska
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinatti Children's Hospital
state: Ohio
city: Springfield
country: United States
facility: Oregon Neurology Associates
state: Oregon
city: Pittsburgh
country: United States
facility: AHN
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Chattanooga
country: United States
facility: WR-ClinSearch
state: Tennessee
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
city: El Paso
country: United States
facility: ANESC Research
state: Texas
city: Houston
country: United States
facility: UTHealth Houston
state: Texas
city: Murray
country: United States
facility: Intermountain Health
state: Utah
city: McLean
country: United States
facility: Medstar Health Research Institute
state: Virginia
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne - PPDS
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Odense
country: Denmark
facility: Odense Universitetshospital
state: Fyn
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
state: Pirkanmaa
city: Kuopio
country: Finland
facility: Kuopion yliopistollinen sairaala
state: Pohjois-Savo
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
state: Baden-Württemberg
city: Kehl
country: Germany
facility: Epilepsiezentrum Kork
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Württemberg
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: München
country: Germany
facility: LMU Klinikum der Universität München - Campus Großhadern
state: Bayern
city: Bernau bei Berlin
country: Germany
facility: Epilepsieklinik Tabor
state: Brandenburg
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann-Wolfgang Goethe-Universitat - Schleusenweg 2-16
state: Hessen
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
state: Hessen
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück GmbH
state: Niedersachsen
city: Bielefeld
country: Germany
facility: Krankenhaus Mara gGmbH
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Radeberg
country: Germany
facility: Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
state: Sachsen
city: Berlin
country: Germany
facility: Vivantes - Humboldt Klinikum
city: Ravensburg
country: Germany
facility: Epilepsie-Zentrum Bodensee
city: Alexandroupoli
country: Greece
facility: University General Hospital of Alexandroupolis
city: Thessaloniki
country: Greece
facility: AHEPA University General Hospital of Thessaloniki
city: Chieti
country: Italy
facility: Università degli Studi G. D'Annunzio Chieti-Pescara
state: Abruzzo
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
state: Calabria
city: Napoli
country: Italy
facility: AORN Antonio Cardarelli
state: Campania
city: Bologna
country: Italy
facility: AUSL di Bologna - Ospedale Bellaria
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
state: Lazio
city: Genova
country: Italy
facility: Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
state: Liguria
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l. - PPDS
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
state: Lombardia
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
state: Lombardia
city: Ancona
country: Italy
facility: Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
state: Marche
city: Baggiovara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
state: Modena
city: Pozzilli
country: Italy
facility: IRCCS Istituto Neurologico Mediterraneo Neuromed
state: Molise
city: Calambrone
country: Italy
facility: Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
state: Toscana
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli-Rome
city: Rome
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Di Verona
city: Santa Maria Da Feira
country: Portugal
facility: ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
state: Aveiro
city: Senhora da Hora
country: Portugal
facility: ULS de Matosinhos, EPE - Hospital Pedro Hispano
state: Porto
city: Braga
country: Portugal
facility: Centro Clínico Académico, Braga - Hospital de Braga
city: Coimbra
country: Portugal
facility: ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
city: Lisboa
country: Portugal
facility: ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
city: Lisboa
country: Portugal
facility: Hospital da Luz Torres de Lisboa
city: Târgu-Mureş
country: Romania
facility: Targu-Mures Emergency Clinical County Hospital - Str. Gh. Marinescu nr.50
state: Mures
city: Bucuresti
country: Romania
facility: Emergency University Hospital
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
city: Vigo
country: Spain
facility: CHUVI - H.U. Alvaro Cunqueiro
state: Pontevedra
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS
city: Granada
country: Spain
facility: Hospital Universitario Clínico San Cecilio
city: Granada
country: Spain
facility: Hospital Vithas Granada
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Madrid
country: Spain
facility: Hospital Ruber Internacional (Grupo Quironsalud)
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga - Hospital General
city: Sevilla
country: Spain
facility: Centro de Neurologia Avanzada
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Swansea
country: United Kingdom
facility: Morriston Hospital
state: Glamorgan
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital-PPDS
state: Glasgow City
city: Salford
country: United Kingdom
facility: Salford Royal Hospital - PPDS
state: Manchester
city: Liverpool
country: United Kingdom
facility: The Walton Centre - PPDS
state: Merseyside
city: London
country: United Kingdom
facility: University College London Hospitals (UCLH)
state: Middlesex
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: South Glamorgan
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
References: