A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
- Registration Number
- NCT06132893
- 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 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 Placebo Placebo - BHV-7000 25 mg BHV-7000 - BHV-7000 50 mg BHV-7000 -
- Primary Outcome Measures
Name Time Method Change from Baseline in 28-day average seizure frequency Baseline, Week 8 to Week 20 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with seizure freedom during DB Phase Week 8 to Week 20 To compare the efficacy of BHV-7000 to placebo on seizure freedom (100% seizure reduction during the DB phase). This objective will be measured by proportion of subjects that are seizure free during the double-blind phase.
Percentage of Participants with at at least 50% reduction in seizure frequency per month Baseline, Week 8 to Week 20 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 12 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 20 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.
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 seizure 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 20 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 12 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 20 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 20 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.
Trial Locations
- Locations (122)
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Center for Neurosciences
🇺🇸Tucson, Arizona, United States
Clinical Trials, Inc.
🇺🇸Little Rock, Arkansas, United States
WRN
🇺🇸Rogers, Arkansas, United States
University of California San Diego
🇺🇸La Jolla, California, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Stanford Health Care
🇺🇸Palo Alto, California, United States
Profound Research LLC
🇺🇸Pasadena, California, United States
University of Colorado Anschultz Medical Campus
🇺🇸Aurora, Colorado, United States
Yale School of Medicine - Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
EZR Research LLC
🇺🇸Boca Raton, Florida, United States
Nova Clinical Research, LLC
🇺🇸Bradenton, Florida, United States
University of Florida (Jacksonville)
🇺🇸Jacksonville, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Floridian Research Institute
🇺🇸Miami, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Medsol Clinical Research Center
🇺🇸Port Charlotte, Florida, United States
Santos Research Center
🇺🇸Tampa, Florida, United States
Encore Medical Research of Weston LLC.
🇺🇸Weston, Florida, United States
Pediatrix Medical Group of Florida
🇺🇸Winter Park, Florida, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Hawaii Pacific Neuroscience
🇺🇸Honolulu, Hawaii, United States
Consultants in Epilepsy & Neurology, PLLC
🇺🇸Boise, Idaho, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Revive Research Institute, Inc.
🇺🇸Rochester Hills, Michigan, United States
Accellacare
🇺🇸Mooresville, North Carolina, United States
Bluegrass Epilepsy Research
🇺🇸Lexington, Kentucky, United States
MAESC
🇺🇸Bethesda, Maryland, United States
Javara
🇺🇸Silver Spring, Maryland, United States
Minnesota Epilepsy Group, P.A.
🇺🇸Roseville, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
NEREG
🇺🇸Hackensack, New Jersey, United States
Inst of Neurology
🇺🇸Livingston, New Jersey, United States
Dent Neurosciences Research Center
🇺🇸Amherst, New York, United States
Centro de especialidades médicas Vanguardia
🇨🇱Temuco, Araucanía, Chile
BCHP
🇺🇸Hawthorne, New York, United States
UVM MC
🇺🇸Burlington, Vermont, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Henrico Doctors Neurology Associates, LLC
🇺🇸Richmond, Virginia, United States
Carilion Clinic
🇺🇸Roanoke, Virginia, United States
STAT Research S.A.
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital General de Agudos Dr. José María Ramos Mejia
🇦🇷Balvanera, Ciudad Autónoma De BuenosAires, Argentina
Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102
🇦🇷Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
Hospital Británico de Buenos Aires
🇦🇷Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
Investigaciones Sanatorio Del Sur
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Instituto Privado Kremer
🇦🇷Córdoba, Argentina
Conci Carpinella - Santa Rosa N° 748
🇦🇷Córdoba, Argentina
Kepler Universitätsklinikum Linz - Med Campus III
🇦🇹Linz, Oberösterreich, Austria
Christian Doppler-Klinik - Universitätsklinikum der PMU
🇦🇹Salzburg, Austria
Universitätsklinikum St. Pölten
🇦🇹St. Pölten, Austria
Medizinische Universitat Wien (Medical University of Vienna)
🇦🇹Wien, Austria
UZ Antwerpen
🇧🇪Edegem, Antwerpen, Belgium
Hôpital Erasme
🇧🇪Anderlecht, Brussels, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Brussels, Belgium
CHU UCL Namur - Site Godinne
🇧🇪Yvoir, Namur, Belgium
UZ Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
Northwell Health
🇺🇸New York, New York, United States
Icahn School of Medicine at Mt. Sinai
🇺🇸New York, New York, United States
Stony Brook Medicine
🇺🇸Stony Brook, New York, United States
Five Towns Neuroscience Research
🇺🇸Woodmere, New York, United States
OnSite Clinical Solutions
🇺🇸Charlotte, North Carolina, United States
Wake Forest Baptist
🇺🇸Winston-Salem, North Carolina, United States
NeuroScience Research Center
🇺🇸Canton, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
OSU
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Clinical Research Solutions LLC
🇺🇸Cypress, Texas, United States
Neurology Consultants of Dallas, PA
🇺🇸Dallas, Texas, United States
Tarrant Neurology Consultants
🇺🇸Fort Worth, Texas, United States
Michael E. DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
UT Health San Antonio
🇺🇸San Antonio, Texas, United States
Road Runner Research, Ltd
🇺🇸San Antonio, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Hospital Padre Hurtado
🇨🇱Santiago, Región-MetropolitanadeSantiago, Chile
BIOCINETIC Ltda
🇨🇱Santiago, Región-MetropolitanadeSantiago, Chile
Centro de Investigacion Clinica UC
🇨🇱Santiago, Región-MetropolitanadeSantiago, Chile
Instituto Neurologico Thalamus
🇨🇱Viña del Mar, Valparaíso, Chile
Clinical Hospital Dubrava
🇭🇷Zagreb, Grad Zagreb, Croatia
Clinical Hospital Sveti duh
🇭🇷Zagreb, Grad Zagreb, Croatia
Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29
🇭🇷Zagreb, Grad Zagreb, Croatia
Klinicki bolnicki centar Zagreb
🇭🇷Zagreb, Grad Zagreb, Croatia
Clinical Hospital Center Rijeka - PPDS
🇭🇷Rijeka, Croatia
Fakultni nemocnice u sv. Anny v Brne
🇨🇿Brno, Jihomoravský Kraj, Czechia
Fakultni nemocnice v Motole
🇨🇿Praha, Praha, Hlavní Mesto, Czechia
CHU de Strasbourg - Hôpital de Hautepierre
🇫🇷Strasbourg, Bas-Rhin, France
CHU Dijon Bourgogne
🇫🇷Dijon, Côte-d'Or, France
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
🇫🇷Toulouse, Haute-Garonne, France
CHU de Montpellier- Hôpital Gui De Chauliac
🇫🇷Montpellier, Hérault, France
CHRU de Tours - Hôpital Bretonneau
🇫🇷Tours, Indre-et-Loire, France
CHRU Nancy
🇫🇷Nancy, Meurthe-et-Moselle, France
CHU de Lille - Hopital Claude Huriez
🇫🇷Lille Cedex, Nord, France
Hospices Civils de Lyon - 59 Bd Pinel
🇫🇷Lyon, Rhône, France
Hôpital Pontchaillou
🇫🇷Rennes, France
Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
🇭🇺Pécs, Baranya, Hungary
Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus
🇭🇺Debrecen, Hajdú-Bihar, Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
🇭🇺Budapest, Hungary
SE INK Juhasz Pal Epilepszia Központ
🇭🇺Budapest, Hungary
Kempenhaeghe - PPDS
🇳🇱Heeze, Noord-Brabant, Netherlands
Stichting Epilepsie Instellingen Nederland - Heemstede
🇳🇱Heemstede, Noord-Holland, Netherlands
Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20
🇳🇱Zwolle, Overijssel, Netherlands
Przychodnia VISTAMED
🇵🇱Wrocław, Dolnoslaskie, Poland
Clinical Best Solutions - Lublin
🇵🇱Lublin, Lubelskie, Poland
NZOZ IGNIS dr med. Alicja Lobinska
🇵🇱Świdnik, Lubelskie, Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o
🇵🇱Nowa Sól, Lubuskie, Poland
Santa Familia PTG Lodz
🇵🇱Łódź, Lódzkie, Poland
MTZ Clinical Research Powered by PRATIA - PPDS
🇵🇱Warszawa, Mazowieckie, Poland
Neurosphera SP. Z O.O
🇵🇱Warszawa, Mazowieckie, Poland
Instytut Psychiatrii i Neurologii
🇵🇱Warszawa, Mazowieckie, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
🇵🇱Gdansk, Pomorskie, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
🇵🇱Poznań, Wielkopolskie, Poland
Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6
🇵🇱Gdańsk, Poland
Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44
🇵🇱Katowice, Poland
Pratia MCM Kraków
🇵🇱Kraków, Poland
LANDA Specjalistyczne Gabinety Lekarskie
🇵🇱Kraków, Poland
University Clinical Centre Maribor
🇸🇮Maribor, Slovenia
InnoMed Clinical Trial Centre
🇿🇦Cape Town, Western Cape, South Africa
Groote Schuur Hospital
🇿🇦Cape Town, Western Cape, South Africa
Klinik Lengg AG
🇨🇭Zürich, Zürich (de), Switzerland