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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508539-30 | 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.
This study has two parts, Part A and Part B. Part A is randomized 1:1:1 25 mg of BHV-7000, 50 mg of BHV-7000 or matching placebo. Part B is randomized 1:1 75mg BHV-7000 or matching placebo. Part B will start after Part A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHV-7000 25 mg Part A | Experimental |
| |
| BHV-7000 50 mg Part A | Experimental |
| |
| Placebo Part A | Placebo Comparator |
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| BHV-7000 75 mg Part B | Experimental |
| |
| Placebo Part B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BHV-7000 | Drug | BHV-7000 25 mg. Participants will take blinded investigational product (IP) once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Change from Baseline in 28-day average seizure frequency | 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. | Baseline, Week 8 to Week 20 of Part B |
| Part A: 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 20 of Part A |
| Part A: 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 and 4 laboratory abnormalities. | Week 8 to Week 20 of Part A |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Percentage of Participants with at at least 50% reduction in seizure frequency per month | 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. |
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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 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Contact | 203-404-0410 | clinicaltrials@biohavenpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Recruiting | Phoenix | Arizona | 85013 | United States |
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| BHV-7000 | Drug | BHV-7000 50 mg. Participants will take blinded investigational product (IP) once daily |
|
| Placebo | Drug | Matching placebo taken once daily |
|
| BHV-7000 | Drug | BHV-7000 75 mg. Participants willtake blinded investigational product(IP) once daily |
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| Placebo | Drug | Matching placebo taken once daily |
|
| Baseline, Week 8 to Week 20 of Part B |
| Part B: Change from Baseline in 28-day average seizure frequency during first month of treatment | 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. | Baseline, Week 8 to Week 12 of Part B |
| Part B: Percentage of Participants with at at least 75% reduction in seizure frequency per month | 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. | Baseline, Week 8 to Week 20 of Part B |
| Part B: Percentage of Participants with seizure freedom during DB Phase | 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. | Week 8 to Week 20 of Part B |
| Part B: Change from baseline in 7-day adjusted seizure frequency during first week of treatment | 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. | Baseline, Week 8 to Week 9 of Part B |
| Part B: Change from baseline in Patient Global Impression of Change (PGI-C) | 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" | Baseline, Week 20 of Part B |
| Part B: 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 20 of Part B |
| Part B: 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 and 4 laboratory abnormalities. | Week 8 to Week 20 of Part B |
| Center for Neurosciences | Recruiting | Tucson | Arizona | 85718 | United States |
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| Clinical Trials, Inc. | Recruiting | Little Rock | Arkansas | 72205 | United States |
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| WRN | Withdrawn | Rogers | Arkansas | 72758 | United States |
| University of California San Diego | Recruiting | La Jolla | California | 92041 | United States |
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| University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
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| Stanford Health Care | Recruiting | Palo Alto | California | 94304 | United States |
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| Profound Research LLC | Recruiting | Pasadena | California | 91105 | United States |
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| University of Colorado Anschultz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
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| Yale School of Medicine - Yale-New Haven Hospital | Recruiting | New Haven | Connecticut | 06519 | United States |
| EZR Research LLC | Recruiting | Boca Raton | Florida | 33486 | United States |
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| Nova Clinical Research, LLC | Recruiting | Bradenton | Florida | 34209 | United States |
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| University of Florida (Jacksonville) | Recruiting | Jacksonville | Florida | 32209 | United States |
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| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| Floridian Research Institute | Withdrawn | Miami | Florida | 33179 | United States |
| AdventHealth Orlando | Withdrawn | Orlando | Florida | 32804 | United States |
| Medsol Clinical Research Center | Recruiting | Port Charlotte | Florida | 33952 | United States |
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| Santos Research Center | Recruiting | Tampa | Florida | 33615 | United States |
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| Encore Medical Research of Weston LLC. | Recruiting | Weston | Florida | 33331 | United States |
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| Pediatrix Medical Group of Florida | Withdrawn | Winter Park | Florida | 32789 | United States |
| Augusta University | Recruiting | Augusta | Georgia | 30912 | United States |
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| Hawaii Pacific Neuroscience | Recruiting | Honolulu | Hawaii | 96817 | United States |
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| Consultants in Epilepsy & Neurology, PLLC | Recruiting | Boise | Idaho | 83702 | United States |
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| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| Revive Research Institute, Inc. | Recruiting | Elgin | Illinois | 60123 | United States |
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| Accellacare | Withdrawn | Ames | Iowa | 50010 | United States |
| Bluegrass Epilepsy Research | Recruiting | Lexington | Kentucky | 40504 | United States |
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| MAESC | Recruiting | Bethesda | Maryland | 20817 | United States |
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| Javara | Completed | Silver Spring | Maryland | 20901 | United States |
| Revive Research Institute, Inc. | Withdrawn | Rochester Hills | Michigan | 48307 | United States |
| Minnesota Epilepsy Group, P.A. | Recruiting | Roseville | Minnesota | 55113 | United States |
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| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| NEREG | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Inst of Neurology | Recruiting | Livingston | New Jersey | 07039 | United States |
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| Dent Neurosciences Research Center | Recruiting | Amherst | New York | 14226 | United States |
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| BCHP | Recruiting | Hawthorne | New York | 10532 | United States |
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| Northwell Health | Recruiting | New York | New York | 10021 | United States |
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| Icahn School of Medicine at Mt. Sinai | Withdrawn | New York | New York | 10029 | United States |
| Stony Brook Medicine | Recruiting | Stony Brook | New York | 11794 | United States |
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| Five Towns Neuroscience Research | Recruiting | Woodmere | New York | 11598 | United States |
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| OnSite Clinical Solutions | Withdrawn | Charlotte | North Carolina | 28211 | United States |
| Accellacare | Withdrawn | Mooresville | North Carolina | 28117 | United States |
| Wake Forest Baptist | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| NeuroScience Research Center | Recruiting | Canton | Ohio | 44718 | United States |
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| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45267 | United States |
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| OSU | Recruiting | Columbus | Ohio | 43214 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| UPMC | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Clinical Research Solutions LLC | Withdrawn | Cypress | Texas | 77433 | United States |
| Neurology Consultants of Dallas, PA | Recruiting | Dallas | Texas | 75243 | United States |
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| Tarrant Neurology Consultants | Not yet recruiting | Fort Worth | Texas | 76104 | United States |
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| Michael E. DeBakey VA Medical Center | Withdrawn | Houston | Texas | 77030 | United States |
| UT Health San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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| Road Runner Research, Ltd | Recruiting | San Antonio | Texas | 78249 | United States |
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| University of Utah | Recruiting | Salt Lake City | Utah | 84132 | United States |
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| UVM MC | Withdrawn | Burlington | Vermont | 05401 | United States |
| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
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| Henrico Doctors Neurology Associates, LLC | Recruiting | Richmond | Virginia | 23235 | United States |
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| Carilion Clinic | Recruiting | Roanoke | Virginia | 24011 | United States |
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| STAT Research S.A. | Recruiting | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1013AAB | Argentina |
| Hospital General de Agudos Dr. José María Ramos Mejia | Recruiting | Balvanera | Ciudad Autónoma de BuenosAires | C1221ADC | Argentina |
| Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102 | Recruiting | Buenos Aires | Ciudad Autónoma de BuenosAires | C1431FWO | Argentina |
| Hospital Británico de Buenos Aires | Recruiting | Buenos Aires | Ciudad Autónoma de BuenosAires | C1437JCH | Argentina |
| Investigaciones Sanatorio Del Sur | Recruiting | San Miguel de Tucumán | Tucumán Province | T4000AXL | Argentina |
| Sanatorio de la Trinidad - Mitre | Recruiting | Buenos Aires | C1039AAO | Argentina |
| Hospital Italiano de Buenos Aires | Recruiting | Buenos Aires | C1181ACH | Argentina |
| Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI | Recruiting | Buenos Aires | C1428AQK | Argentina |
| Instituto Privado Kremer | Recruiting | Córdoba | X5004AOA | Argentina |
| Conci Carpinella - Santa Rosa N° 748 | Recruiting | Córdoba | X5008HHW | Argentina |
| Kepler Universitätsklinikum Linz - Med Campus III | Recruiting | Linz | Upper Austria | 4020 | Austria |
| Christian Doppler-Klinik - Universitätsklinikum der PMU | Recruiting | Salzburg | 5020 | Austria |
| Universitätsklinikum St. Pölten | Recruiting | Sankt Pölten | 3100 | Austria |
| Medizinische Universitat Wien (Medical University of Vienna) | Recruiting | Vienna | 1090 | Austria |
| UZ Antwerpen | Recruiting | Edegem | Antwerpen | 2650 | Belgium |
| Hôpital Erasme | Recruiting | Anderlecht | Brussels Capital | 1070 | Belgium |
| Cliniques Universitaires Saint-Luc | Recruiting | Brussels | Brussels Capital | 1200 | Belgium |
| CHU UCL Namur - Site Godinne | Recruiting | Yvoir | Namur | 5530 | Belgium |
| UZ Gent | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Centro de especialidades médicas Vanguardia | Recruiting | Temuco | Araucania | 4780000 | Chile |
| Hospital Padre Hurtado | Recruiting | Santiago | Región-MetropolitanadeSantiago | 8260094 | Chile |
| BIOCINETIC Ltda | Recruiting | Santiago | Región-MetropolitanadeSantiago | 8320000 | Chile |
| Centro de Investigacion Clinica UC | Recruiting | Santiago | Región-MetropolitanadeSantiago | 8320000 | Chile |
| Instituto Neurologico Thalamus | Recruiting | Viña del Mar | Valparaiso | 2520021 | Chile |
| Clinical Hospital Sveti duh | Recruiting | Zagreb | City of Zagreb | 10000 | Croatia |
| Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29 | Recruiting | Zagreb | City of Zagreb | 10000 | Croatia |
| Clinical Hospital Center Rijeka - PPDS | Recruiting | Rijeka | 51000 | Croatia |
| Fakultni nemocnice v Motole | Recruiting | Prague | Praha, Hlavní Mesto | 150 06 | Czechia |
| Fakultni nemocnice u sv. Anny v Brne | Recruiting | Brno | South Moravian | 602 00 | Czechia |
| CHU de Strasbourg - Hôpital de Hautepierre | Not yet recruiting | Strasbourg | Bas-Rhin | 67000 | France |
| CHU Dijon Bourgogne | Recruiting | Dijon | Côte-d'Or | 21000 | France |
| CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan | Recruiting | Toulouse | Haute-Garonne | 31059 | France |
| CHU de Montpellier- Hôpital Gui De Chauliac | Recruiting | Montpellier | Hérault | 34295 | France |
| CHRU de Tours - Hôpital Bretonneau | Recruiting | Tours | Indre-et-Loire | 37000 | France |
| CHRU Nancy | Recruiting | Nancy | Meurthe-et-Moselle | 54000 | France |
| CHU de Lille - Hopital Claude Huriez | Recruiting | Lille | Nord | 59037 | France |
| Hospices Civils de Lyon - 59 Bd Pinel | Recruiting | Lyon | Rhône | 69003 | France |
| Hôpital Pontchaillou | Recruiting | Rennes | 35033 | France |
| Pécsi Tudományegyetem Klinikai Kozpont -Ret u. | Recruiting | Pécs | Baranya | 7623 | Hungary |
| Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus | Recruiting | Debrecen | Hajdú-Bihar | 4031 | Hungary |
| Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet | Recruiting | Budapest | 1106 | Hungary |
| SE INK Juhasz Pal Epilepszia Központ | Not yet recruiting | Budapest | 1145 | Hungary |
| Kempenhaeghe - PPDS | Recruiting | Heeze | North Brabant | 5591 VE | Netherlands |
| Stichting Epilepsie Instellingen Nederland - Heemstede | Recruiting | Heemstede | North Holland | 2103 SW | Netherlands |
| Stichting Epilepsie Instellingen Nederland - Dokter Denekampweg 20 | Recruiting | Zwolle | Overijssel | 8025 BV | Netherlands |
| AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu | Recruiting | Poznan | Greater Poland Voivodeship | 60-702 | Poland |
| Przychodnia VISTAMED | Recruiting | Wroclaw | Lower Silesian Voivodeship | 53-149 | Poland |
| Clinical Best Solutions - Lublin | Recruiting | Lublin | Lublin Voivodeship | 20-078 | Poland |
| NZOZ IGNIS dr med. Alicja Lobinska | Recruiting | Świdnik | Lublin Voivodeship | 21-040 | Poland |
| Twoja Przychodnia Nowosolskie Centrum Medyczne sp. z o.o | Recruiting | Nowa Sól | Lubusz Voivodeship | 67-100 | Poland |
| Santa Familia PTG Lodz | Recruiting | Lodz | Lódzkie | 90-302 | Poland |
| MTZ Clinical Research Powered by PRATIA - PPDS | Recruiting | Warsaw | Masovian Voivodeship | 02-172 | Poland |
| Neurosphera SP. Z O.O | Recruiting | Warsaw | Masovian Voivodeship | 02-829 | Poland |
| Instytut Psychiatrii i Neurologii | Recruiting | Warsaw | Masovian Voivodeship | 02-957 | Poland |
| Centrum Badan Klinicznych PI-House sp. z o.o. | Recruiting | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| Copernicus Podmiot Leczniczy Sp. z o.o. - ul. Nowe Ogrody 1-6 | Recruiting | Gdansk | 80-803 | Poland |
| Novo-Med Zielinski i wsp. Sp.J. - ul. Brynowska 44 | Recruiting | Katowice | 40-594 | Poland |
| Pratia MCM Kraków | Recruiting | Krakow | 30-727 | Poland |
| LANDA Specjalistyczne Gabinety Lekarskie | Recruiting | Krakow | 31-156 | Poland |
| University Clinical Centre Maribor | Recruiting | Maribor | 2000 | Slovenia |
| InnoMed Clinical Trial Centre | Recruiting | Cape Town | Western Cape | 7530 | South Africa |
| Groote Schuur Hospital | Recruiting | Cape Town | Western Cape | 7700 | South Africa |
| Klinik Lengg AG | Recruiting | Zurich | Zürich (de) | 8008 | Switzerland |
| 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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