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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508811-21 | Registry Identifier | EU CTR |
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The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHV-7000 50 mg | Experimental |
| |
| BHV-7000 75 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BHV-7000 | Drug | BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in 28-day average seizure frequency | To compare the efficacy of 75mg 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. | Baseline, Week 8 to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with at at least 50% reduction in seizure frequency per month | To compare the efficacy 75mg 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. |
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Key Inclusion Criteria:
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 Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onyx Clinical Trials | Peoria | Arizona | 85381 | United States | ||
| Xenoscience, Inc. |
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| BHV-7000 | Drug | BHV-7000 75 mg. Participants will take blinded investigational product (IP) once daily |
|
| Placebo | Drug | Matching placebo taken once daily |
|
| Baseline, Week 8 to Week 16 |
| Change from Baseline in 28-day average seizure frequency | To compare the efficacy of each of 50mg 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. | Baseline, Week 8 to Week 16 |
| Percentage of Participants with at at least 50% reduction in seizure frequency per month | To compare the efficacy of 50mg 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. | Baseline, Week 8 to Week 16 |
| 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 16 |
| 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 or 4 laboratory abnormalities. | Week 8 to Week 16 |
| Phoenix |
| Arizona |
| 85004 |
| United States |
| University of Arizona / Banner University Medical Center Phoenix | Phoenix | Arizona | 85006 | United States |
| ARENSIA Exploratory Medicine | Phoenix | Arizona | 85015 | United States |
| Clinical Trials, Inc. | Little Rock | Arkansas | 72205 | United States |
| Tri Valley Neurology Medical Associates, Inc. | Mission Hills | California | 91345 | United States |
| Profound Research LLC | Poway | California | 92065 | United States |
| UConn Health | Farmington | Connecticut | 06030 | United States |
| Nova Clinical Research, LLC | Bradenton | Florida | 34209 | United States |
| Las Mercedes Medical Research | Hialeah | Florida | 33012 | United States |
| Coral Clinic Research | Homestead | Florida | 33032 | United States |
| Y&L Advance Health Care, Inc d/b/a Elite Clinical Research | Miami | Florida | 33144 | United States |
| Serenity Research Center | Miami | Florida | 33176 | United States |
| Research Institute of Orlando | Orlando | Florida | 32806 | United States |
| Comprehensive Neurology Clinic | Orlando | Florida | 32825 | United States |
| Panhandle Research & Medical Clinic | Pensacola | Florida | 32502 | United States |
| Knight Neurology | Rockledge | Florida | 32955 | United States |
| Encore Medical Research of Weston LLC. | Weston | Florida | 33331 | United States |
| Accelerated Clinical Trials, LLC | Peachtree Corners | Georgia | 30071 | United States |
| Bluegrass Epilepsy Research | Lexington | Kentucky | 40504 | United States |
| DelRicht Research | Baton Rouge | Louisiana | 70810 | United States |
| Neurocare Of Louisiana | Covington | Louisiana | 70433 | United States |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | United States |
| DelRicht Research | New Orleans | Louisiana | 70119 | United States |
| LSU Health Shreveport | Shreveport | Louisiana | 71103 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Boston Neuro Research | South Dartmouth | Massachusetts | 02747 | United States |
| SRI International | Plymouth | Michigan | 48170 | United States |
| University of Missouri Health Care | Columbia | Missouri | 65212 | United States |
| Somnos Clinical Research | Lincoln | Nebraska | 68510 | United States |
| NEREG | Hackensack | New Jersey | 07601 | United States |
| Tekton Research | Marlboro | New Jersey | 07746 | United States |
| Dent Neurosciences Research Center | Amherst | New York | 14226 | United States |
| Northwell Health | Great Neck | New York | 11021 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Premier Health | Dayton | Ohio | 45409 | United States |
| Oregon Neurology Associates | Springfield | Oregon | 97477 | United States |
| AHN | Pittsburgh | Pennsylvania | 15212 | United States |
| MUSC | Charleston | South Carolina | 29425 | United States |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | United States |
| Horizon Clinical Research Group | Cypress | Texas | 77429 | United States |
| M3 Wake Research-Dallas | Dallas | Texas | 75246 | United States |
| ANESC Research | El Paso | Texas | 79912 | United States |
| UTHealth Houston | Houston | Texas | 77030 | United States |
| UTHSC | Houston | Texas | 77030 | United States |
| Stryde Research | Plano | Texas | 75093 | United States |
| Intermountain Health | Murray | Utah | 84107 | United States |
| Medstar Health Research Institute | McLean | Virginia | 22101 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia |
| Royal Brisbane & Women's Hospital | Herston | Queensland | 4029 | Australia |
| St Vincents Hospital Melbourne - PPDS | Fitzroy | Victoria | 3065 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Flinders Medical Centre | Bedford Park | 5042 | Australia |
| Odense Universitetshospital | Odense | Fyn | 5000 | Denmark |
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
| Epilepsihospitalet Filadelfia | Dianalund | 4293 | Denmark |
| Kuopion yliopistollinen sairaala | Kuopio | Northern Savonia | 70200 | Finland |
| Tampereen yliopistollinen sairaala | Tampere | Pirkanmaa | 33520 | Finland |
| Helsinki University Hospital | Helsinki | Uusimaa | 00290 | Finland |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Epilepsiezentrum Kork | Kehl | Baden-Wurttemberg | 77694 | Germany |
| Universitätsklinikum Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany |
| Universitätsklinikum Erlangen | Erlangen | Bavaria | 91054 | Germany |
| Epilepsieklinik Tabor | Bernau bei Berlin | Brandenburg | 16321 | Germany |
| Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg | Marburg | Hesse | 35043 | Germany |
| Klinikum Osnabrück GmbH | Osnabrück | Lower Saxony | 49076 | Germany |
| Krankenhaus Mara gGmbH | Bielefeld | North Rhine-Westphalia | 33617 | Germany |
| Universitätsklinikum Bonn | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Universitätsklinikum Münster | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitätsklinikum Leipzig | Leipzig | Saxony | 04103 | Germany |
| Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh | Radeberg | Saxony | 01454 | Germany |
| Vivantes - Humboldt Klinikum | Berlin | 13509 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | 60590 | Germany |
| Epilepsie-Zentrum Bodensee | Ravensburg | 88214 | Germany |
| University General Hospital of Alexandroupolis | Alexandroupoli | 681 00 | Greece |
| University General Hospital ''ATTIKON'' | Chaïdári | 124 62 | Greece |
| AHEPA University General Hospital of Thessaloniki | Thessaloniki | 546 36 | Greece |
| Georgios Papanikolaou General Hospital of Thessaloniki | Thessaloniki | 546 36 | Greece |
| Semmel Egyet Idegsebésze Neuro Klin | Budapest | 1145 | Hungary |
| Nizam's Insti. of Medical Sciences | Hyderabad | 500082 | India |
| Mallikatta Neuro Centre | Mangalore | 575002 | India |
| Jaslok Hospital and Research | Mumbai | 400026 | India |
| Dr G M Taori Memorial CIIMS | Nagpur | 440010 | India |
| All India Institute of Medical Sciences (AIIMS) | New Delhi | 110029 | India |
| Università degli Studi G. D'Annunzio Chieti-Pescara | Chieti | Abruzzo | 66013 | Italy |
| Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini | Catanzaro | Calabria | 88100 | Italy |
| AORN Antonio Cardarelli | Naples | Campania | 80131 | Italy |
| AUSL di Bologna - Ospedale Bellaria | Bologna | Emilia-Romagna | 40123 | Italy |
| Fondazione PTV Policlinico Tor Vergata | Rome | Lazio | 00133 | Italy |
| Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN | Genoa | Liguria | 16147 | Italy |
| Ospedale San Raffaele S.r.l. - PPDS | Milan | Lombardy | 20132 | Italy |
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Milan | Lombardy | 20133 | Italy |
| ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo | Milan | Lombardy | 20142 | Italy |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS | Pavia | Lombardy | 27100 | Italy |
| Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara | Baggiovara | Modena | 41126 | Italy |
| IRCCS Istituto Neurologico Mediterraneo Neuromed | Pozzilli | Molise | 86077 | Italy |
| Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN | Calambrone | Tuscany | 56018 | Italy |
| Fondazione Policlinico Universitario A Gemelli-Rome | Roma | 00168 | Italy |
| IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN | Rome | 00165 | Italy |
| Clinstile, S.A. de C.V. | Mexico City | 06700 | Mexico |
| Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city | Mexico City | 14050 | Mexico |
| Accelerium, S. de R.L. de C.V. - PPDS | Monterrey | 64000 | Mexico |
| Axis Heilsa S. de R.L. de C.V. | Obispado | 64060 | Mexico |
| Neurociencias Estudios Clinicos S.C. | Sinaloa | 80020 | Mexico |
| Clinical Research Institute SC-Mexico | Tlalnepantla | 54055 | Mexico |
| FAICIC S De RL De CV | Veracruz | 91900 | Mexico |
| MTZ Clinical Research | Krakow | 02-172 | Poland |
| Pratia MCM Krakow | Krakow | 30-727 | Poland |
| LANDA Specjalistyczne | Krakow | 31-156 | Poland |
| Neurosphera SP. Z O.O | Warsaw | 02-829 | Poland |
| Premium Clinic Wrocław | Wroclaw | 50-414 | Poland |
| ULS de Entre Douro e Vouga, EPE - Hospital de São Sebastião | Santa Maria da Feira | Aveiro District | 4520-211 | Portugal |
| ULS de Matosinhos, EPE - Hospital Pedro Hispano | Senhora da Hora | Porto District | 4454-509 | Portugal |
| Centro Clínico Académico, Braga - Hospital de Braga | Braga | 4710-243 | Portugal |
| ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz | Lisbon | 1449-005 | Portugal |
| Hospital da Luz Torres de Lisboa | Lisbon | 1600-209 | Portugal |
| Emergency University Hospital | Bucharest | 11635 | Romania |
| IN MEDIC, s.r.o. | Bardejov | 085 01 | Slovakia |
| Kraskova 2636, Neurologické oddelenie | Rimavská Sobota | 979 01 | Slovakia |
| Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitario de Navarra | Pamplona | Navarre | 31008 | Spain |
| CHUVI - H.U. Alvaro Cunqueiro | Vigo | Pontevedra | 36312 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitario Vall d'Hebron - PPDS | Barcelona | 08035 | Spain |
| Fundacio Assistencial Mutua de Terrassa | Barcelona | 08221 | Spain |
| Hospital Universitario Clínico San Cecilio | Granada | 18007 | Spain |
| Hospital Vithas Granada | Granada | 18008 | Spain |
| Hospital Universitario Virgen de Las Nieves | Granada | 18013 | Spain |
| Hospital Ruber Internacional (Grupo Quironsalud) | Madrid | 28034 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital blua sanitas valdebebas | Madrid | 28055 | Spain |
| Hospital Regional Universitario de Malaga - Hospital General | Málaga | 29010 | Spain |
| Centro de Neurologia Avanzada | Seville | 41013 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | 47003 | Spain |
| Morriston Hospital | Swansea | Glamorgan | SA6 6NL | United Kingdom |
| Queen Elizabeth University Hospital-PPDS | Glasgow | Glasgow City | G51 4TF | United Kingdom |
| Salford Royal Hospital - PPDS | Salford | Manchester | M6 8HD | United Kingdom |
| The Walton Centre - PPDS | Liverpool | Merseyside | L9 7LJ | United Kingdom |
| John Radcliffe Hospital | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| University Hospital of Wales | Cardiff | South Glamorgan | CF14 4XW | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| St Georges NHS Foundation Trust | London | SW17 0QT | United Kingdom |
| The Royal London Hospital | London | WC1N 3HR | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| D012640 | Seizures |
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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