Език: EN EN
← Назад към резултатите
Набира участници Фаза 2/3 NCT06309966

Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy

Фаза 2/3 – комбинирано изпитване
Заболявания: Focal Epilepsy

Спонсор: Biohaven Therapeutics Ltd.

Налично на: БГ
Обобщение
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Кой може да участва
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
Места на провеждане 14
Австралия (1)
Royal Prince Alfred Hospital
Camperdown , New South Wales
Дания (1)
Odense Universitetshospital
Odense , Fyn
Финландия (1)
Kuopion yliopistollinen sairaala
Kuopio , Northern Savonia
Гърция (1)
University General Hospital of Alexandroupolis
Alexandroupoli
Унгария (1)
Semmel Egyet Idegsebésze Neuro Klin
Budapest
Индия (1)
Nizam's Insti. of Medical Sciences
Hyderabad
Италия (1)
Università degli Studi G. D'Annunzio Chieti-Pescara
Chieti , Abruzzo
Mexico (1)
Clinstile, S.A. de C.V.
Mexico City
Полша (1)
MTZ Clinical Research
Krakow
Румъния (1)
Targu-Mures Emergency Clinical County Hospital - Str. Gh. Marinescu nr.50
Târgu Mureş , Mureș County
Словакия (1)
IN MEDIC, s.r.o.
Bardejov
Испания (1)
Hospital Universitario Germans Trias i Pujol
Badalona , Barcelona
Великобритания (1)
Morriston Hospital
Swansea , Glamorgan
САЩ (1)
Accel Research
Birmingham , Alabama
WITHDRAWN
Технически детайли
Статус
Набира участници
Фаза
Фаза 2/3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
13.05.2024
Крайна дата
01.05.2026
Регистрационен номер
NCT06309966
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.