Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
- Registration Number
- NCT06309966
- Lead Sponsor
- Biohaven Therapeutics Ltd.
- Brief Summary
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 390
-
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 with clinically observable signs and/or symptoms 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BHV-7000 50 mg BHV-7000 - BHV-7000 75 mg BHV-7000 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from Baseline in 28-day average seizure frequency Baseline, Week 8 to Week 16 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 8-week double-blind treatment phase.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with at at least 50% reduction in seizure frequency per month Baseline, Week 8 to Week 16 To compare the efficacy of 2 dose strengths of BHV-7000 to placebo as adjunctive therapy for refractory focal onset epilepsy as measured by the proportion of subjects that have at least a 50% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the 8 week double-blind phase to the observation phase.
Change from Baseline in 28-day average seizure frequency during first month of treatment Baseline, Week 8 to Week 12 To compare the efficacy of BHV-7000 to placebo during the first month of treatment. This objective will be measured by the change in log-transformed 28-day adjusted seizure frequency from observation phase over the first month of the double blind phase.
Percentage of Participants with at at least 75% reduction in seizure frequency per month Baseline, Week 8 to Week 16 To compare the efficacy of BHV-7000 to placebo as measured by the proportion of subjects that have at least a 75% reduction in seizures per month (28 days). This objective will be measured by comparing the proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the double-blind phase compared to the observation phase.
Percentage of Participants with seizure freedom during DB Phase Week 8 to Week 16 To compare the efficacy of BHV-7000 to placebo on seizure freedom (100% seizure reduction during the DBP phase). This objective will be measured by proportion of subjects that are seizure free during the double-blind phase.
Change from baseline in 7-day adjusted seizure frequency during first week of treatment Baseline, Week 8 to Week 9 To compare the efficacy of BHV-7000 to placebo during the first week of treatment. This objective will be measured by the change in log-transformed 7-day adjusted seziure frequency from observation phase over the first week of the double-blind phase.
Change from baseline in Patient Global Impression of Change (PGI-C) Baseline, Week 16 To compare the efficacy of BHV-7000 to placebo on the patient global impression of change (PGI-C). This objective will be measured by proportion of subjects at week 8 of double-blind treatment phase with a PGI-C response of "minimally improved", "much improved" or "very much improved". This scale is a 7-point Likert scale with response options of:
(1) "very much improved" , (2) "much improved", (3) "minimally improved", (4) "no change", (5) "minimally worse", (6) "much worse", (7) and "very much worse"Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs Week 8 to Week 16 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.
Number of Participants With Clinically Significant Laboratory Abnormalities Week 8 to Week 16 To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.
Trial Locations
- Locations (158)
Fondazione Policlinico Universitario A Gemelli-Rome
🇮🇹Roma, Italy
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
🇮🇹Rome, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
🇮🇹Verona, Italy
Universitätsklinikum Leipzig
🇩🇪Leipzig, Sachsen, Germany
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
🇩🇪Radeberg, Sachsen, Germany
Vivantes - Humboldt Klinikum
🇩🇪Berlin, Germany
Epilepsie-Zentrum Bodensee
🇩🇪Ravensburg, Germany
Università degli Studi G. D'Annunzio Chieti-Pescara
🇮🇹Chieti, Abruzzo, Italy
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
🇮🇹Catanzaro, Calabria, Italy
AORN Antonio Cardarelli
🇮🇹Napoli, Campania, Italy
AUSL di Bologna - Ospedale Bellaria
🇮🇹Bologna, Emilia-Romagna, Italy
Fondazione PTV Policlinico Tor Vergata
🇮🇹Roma, Lazio, Italy
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
🇮🇹Genova, Liguria, Italy
Ospedale San Raffaele S.r.l. - PPDS
🇮🇹Milano, Lombardia, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Lombardia, Italy
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
🇮🇹Milano, Lombardia, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
🇮🇹Pavia, Lombardia, Italy
Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
🇮🇹Ancona, Marche, Italy
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
🇮🇹Baggiovara, Modena, Italy
IRCCS Istituto Neurologico Mediterraneo Neuromed
🇮🇹Pozzilli, Molise, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
🇮🇹Calambrone, Toscana, Italy
ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
🇵🇹Santa Maria Da Feira, Aveiro, Portugal
ULS de Matosinhos, EPE - Hospital Pedro Hispano
🇵🇹Senhora da Hora, Porto, Portugal
Centro ClÃnico Académico, Braga - Hospital de Braga
🇵🇹Braga, Portugal
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
🇵🇹Coimbra, Portugal
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
🇵🇹Lisboa, Portugal
Hospital da Luz Torres de Lisboa
🇵🇹Lisboa, Portugal
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario de Bellvitge
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Universitario de Navarra
🇪🇸Pamplona, Navarra, Spain
CHUVI - H.U. Alvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Vall d'Hebron - PPDS
🇪🇸Barcelona, Spain
Hospital Universitario ClÃnico San Cecilio
🇪🇸Granada, Spain
Hospital Vithas Granada
🇪🇸Granada, Spain
Hospital Universitario Virgen de Las Nieves
🇪🇸Granada, Spain
Hospital Ruber Internacional (Grupo Quironsalud)
🇪🇸Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga - Hospital General
🇪🇸Málaga, Spain
Centro de Neurologia Avanzada
🇪🇸Sevilla, Spain
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain
Morriston Hospital
🇬🇧Swansea, Glamorgan, United Kingdom
Queen Elizabeth University Hospital-PPDS
🇬🇧Glasgow, Glasgow City, United Kingdom
Salford Royal Hospital - PPDS
🇬🇧Salford, Manchester, United Kingdom
The Walton Centre - PPDS
🇬🇧Liverpool, Merseyside, United Kingdom
University College London Hospitals (UCLH)
🇬🇧London, Middlesex, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, South Glamorgan, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle Upon Tyne, United Kingdom
Oregon Neurology Associates
🇺🇸Springfield, Oregon, United States
Accel Research
🇺🇸Birmingham, Alabama, United States
Xenoscience, Inc.
🇺🇸Phoenix, Arizona, United States
ARENSIA Exploratory Medicine
🇺🇸Phoenix, Arizona, United States
Amicis Research Center
🇺🇸Lancaster, California, United States
Memorialcare Miller Children's & Women's Hospital Long Beach
🇺🇸Long Beach, California, United States
Profound Research LLC
🇺🇸Poway, California, United States
Kaiser Permanente
🇺🇸Aurora, Colorado, United States
UConn Health
🇺🇸Farmington, Connecticut, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Dm Healthworks
🇺🇸Kissimmee, Florida, United States
Y&L Advance Health Care, Inc d/b/a Elite Clinical Research
🇺🇸Miami, Florida, United States
Serenity Research Center
🇺🇸Miami, Florida, United States
Research Institute of Orlando
🇺🇸Orlando, Florida, United States
Comprehensive Neurology Clinic
🇺🇸Orlando, Florida, United States
Knight Neurology
🇺🇸Rockledge, Florida, United States
PENS
🇺🇸Tampa, Florida, United States
OLORMC
🇺🇸Baton Rouge, Louisiana, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
University Medical Center New Orleans
🇺🇸New Orleans, Louisiana, United States
LSU Health Shreveport
🇺🇸Shreveport, Louisiana, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Somnos Clinical Research
🇺🇸Lincoln, Nebraska, United States
Northwell Health
🇺🇸Great Neck, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
UNC-Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Cincinatti Children's Hospital
🇺🇸Cincinnati, Ohio, United States
AHN
🇺🇸Pittsburgh, Pennsylvania, United States
MUSC
🇺🇸Charleston, South Carolina, United States
WR-ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
ANESC Research
🇺🇸El Paso, Texas, United States
UTHealth Houston
🇺🇸Houston, Texas, United States
Intermountain Health
🇺🇸Murray, Utah, United States
Medstar Health Research Institute
🇺🇸McLean, Virginia, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Royal Brisbane & Women's Hospital
🇦🇺Herston, Queensland, Australia
St Vincents Hospital Melbourne - PPDS
🇦🇺Fitzroy, Victoria, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Odense Universitetshospital
🇩🇰Odense, Fyn, Denmark
Tampereen yliopistollinen sairaala
🇫🇮Tampere, Pirkanmaa, Finland
Kuopion yliopistollinen sairaala
🇫🇮Kuopio, Pohjois-Savo, Finland
Helsinki University Hospital
🇫🇮Helsinki, Uusimaa, Finland
Universitätsklinikum Freiburg
🇩🇪Freiburg, Baden-Württemberg, Germany
Epilepsiezentrum Kork
🇩🇪Kehl, Baden-Württemberg, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Baden-Württemberg, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Bayern, Germany
LMU Klinikum der Universität München - Campus Großhadern
🇩🇪München, Bayern, Germany
Epilepsieklinik Tabor
🇩🇪Bernau bei Berlin, Brandenburg, Germany
Klinikum der Johann-Wolfgang Goethe-Universitat - Schleusenweg 2-16
🇩🇪Frankfurt am Main, Hessen, Germany
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
🇩🇪Marburg, Hessen, Germany
Klinikum Osnabrück GmbH
🇩🇪Osnabrück, Niedersachsen, Germany
Krankenhaus Mara gGmbH
🇩🇪Bielefeld, Nordrhein-Westfalen, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Universitätsklinikum Münster
🇩🇪Münster, Nordrhein-Westfalen, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Sachsen, Germany
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
🇩🇪Radeberg, Sachsen, Germany
Vivantes - Humboldt Klinikum
🇩🇪Berlin, Germany
Epilepsie-Zentrum Bodensee
🇩🇪Ravensburg, Germany
Università degli Studi G. D'Annunzio Chieti-Pescara
🇮🇹Chieti, Abruzzo, Italy
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
🇮🇹Catanzaro, Calabria, Italy
AORN Antonio Cardarelli
🇮🇹Napoli, Campania, Italy
AUSL di Bologna - Ospedale Bellaria
🇮🇹Bologna, Emilia-Romagna, Italy
Fondazione PTV Policlinico Tor Vergata
🇮🇹Roma, Lazio, Italy
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
🇮🇹Genova, Liguria, Italy
Ospedale San Raffaele S.r.l. - PPDS
🇮🇹Milano, Lombardia, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Lombardia, Italy
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
🇮🇹Milano, Lombardia, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
🇮🇹Pavia, Lombardia, Italy
Università Politecnica delle Marche Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
🇮🇹Ancona, Marche, Italy
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
🇮🇹Baggiovara, Modena, Italy
IRCCS Istituto Neurologico Mediterraneo Neuromed
🇮🇹Pozzilli, Molise, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
🇮🇹Calambrone, Toscana, Italy
Fondazione Policlinico Universitario A Gemelli-Rome
🇮🇹Roma, Italy
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
🇮🇹Rome, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
🇮🇹Verona, Italy
ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião
🇵🇹Santa Maria Da Feira, Aveiro, Portugal
ULS de Matosinhos, EPE - Hospital Pedro Hispano
🇵🇹Senhora da Hora, Porto, Portugal
Centro ClÃnico Académico, Braga - Hospital de Braga
🇵🇹Braga, Portugal
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
🇵🇹Coimbra, Portugal
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
🇵🇹Lisboa, Portugal
Hospital da Luz Torres de Lisboa
🇵🇹Lisboa, Portugal
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario de Bellvitge
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Universitario de Navarra
🇪🇸Pamplona, Navarra, Spain
CHUVI - H.U. Alvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Vall d'Hebron - PPDS
🇪🇸Barcelona, Spain
Hospital Universitario ClÃnico San Cecilio
🇪🇸Granada, Spain
Hospital Vithas Granada
🇪🇸Granada, Spain
Hospital Universitario Virgen de Las Nieves
🇪🇸Granada, Spain
Hospital Ruber Internacional (Grupo Quironsalud)
🇪🇸Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga - Hospital General
🇪🇸Málaga, Spain
Centro de Neurologia Avanzada
🇪🇸Sevilla, Spain
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain
Morriston Hospital
🇬🇧Swansea, Glamorgan, United Kingdom
Queen Elizabeth University Hospital-PPDS
🇬🇧Glasgow, Glasgow City, United Kingdom
Salford Royal Hospital - PPDS
🇬🇧Salford, Manchester, United Kingdom
The Walton Centre - PPDS
🇬🇧Liverpool, Merseyside, United Kingdom
University College London Hospitals (UCLH)
🇬🇧London, Middlesex, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, South Glamorgan, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle Upon Tyne, United Kingdom