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Само по покана Фаза 2 NCT06443463

Long-term Safety and Tolerability of BHV-7000

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Focal Epilepsy

Спонсор: Biohaven Therapeutics Ltd.

Налично на: БГ
Обобщение
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
Кой може да участва
Key Inclusion Criteria: * Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303. * (FOCBP) Females of Child Bearing Potential must have a negative urine pregnancy test at the Baseline/Day 0 visit Key Exclusion Criteria: * Any condition, such as an ongoing AE with/without sequelae, or is poorly tolerating IP in the double-blind phase of the parent study, 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. * Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures
Места на провеждане 23
Argentina (1)
STAT Research S.A.
Ciudad Autónoma de Buenos Aires , Buenos Aires
Австралия (1)
Royal Prince Alfred Hospital
Camperdown , New South Wales
Белгия (1)
UZ Antwerpen
Edegem , Antwerpen
Chile (1)
Centro de especialidades médicas Vanguardia
Temuco , Araucania
Хърватия (1)
Clinical Hospital Dubrava
Zagreb , City of Zagreb
Чехия (1)
Fakultni nemocnice v Motole
Prague , Praha, Hlavní Mesto
Дания (1)
Odense Universitetshospital
Odense , Fyn
Финландия (1)
Kuopion yliopistollinen sairaala
Kuopio , Northern Savonia
Франция (1)
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg , Bas-Rhin
Гърция (1)
University General Hospital of Alexandroupolis
Alexandroupoli
Унгария (1)
Pécsi Tudományegyetem Klinikai Kozpont -Ret u.
Pécs , Baranya
Индия (1)
Nizam's Insti. of Medical Sciences
Hyderabad
Италия (1)
Università degli Studi G. D'Annunzio Chieti-Pescara
Chieti , Abruzzo
Mexico (1)
Unidad de Investigación en Salud de Chihuahua S.C.-Mexico city
Mexico City
Нидерландия (1)
Kempenhaeghe - PPDS
Heeze , North Brabant
Полша (1)
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan , Greater Poland Voivodeship
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
South Africa (1)
InnoMed Clinical Trial Centre
Cape Town , Western Cape
Испания (1)
Hospital Universitario Germans Trias i Pujol
Badalona , Barcelona
Швейцария (1)
Klinik Lengg AG
Zurich , Zürich (de)
Великобритания (1)
Morriston Hospital
Swansea , Glamorgan
САЩ (1)
Accel Research
Birmingham , Alabama
Технически детайли
Статус
Само по покана
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
30.07.2024
Крайна дата
01.01.2027
Регистрационен номер
NCT06443463
Източник
anzctr
Запитване за медицински туризъм

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