Език: EN EN
← Назад към резултатите
Набира участници Фаза 2 NCT07197866

An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Multiple System Atrophy

Спонсор: Teva Branded Pharmaceutical Products R&D LLC

Налично на: БГ
Обобщение
The primary objective of the trial is to describe the long-term safety and tolerability of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). A secondary objective of the trial is to further describe the safety and tolerability of TEV-56286. The planned total duration of the trial is approximately 100 weeks.
Кой може да участва
Inclusion Criteria: * Completion of the treatment period and the week 48(V9) visit of the double-blind trial (TV56286-NDG-20039) whilst remaining compliant with trial requirements * Females of childbearing potential may be included only if they have a negative pregnancy test at the baseline visit * Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the trial and for 28 days after the last does of IMP * Males who are potentially fertile/reproductively competent (not surgically \[eg, vasectomy\] or congenitally sterile) and their female partners who are of childbearing potential must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 28 days after the last dose of investigational medicinal product NOTE - Additional criteria apply, please contact the investigator for more information Exclusion Criteria: * Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the trial * Is of a vulnerable population (eg, people kept in detention or jail) * Is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial Note - Additional criteria apply, please contact the investigator for more information
Интервенции
TEV-56286
DRUG
Места на провеждане 15
Франция (3)
Teva Investigational Site 35290
Bordeaux
Teva Investigational Site 35291
Paris
Teva Investigational Site 35292
Toulouse
NOT_YET_RECRUITING
Германия (1)
Teva Investigational Site 32818
Dresden
Израел (1)
Teva Investigational Site 80203
Haifa
Италия (1)
Teva Investigational Site 30299
Bologna
Япония (1)
Teva Investigational Site 84141
Sanda-shi
Испания (3)
Teva Investigational Site 31324
Barcelona
Teva Investigational Site 31323
Barcelona
Teva Investigational Site 31322
Seville
САЩ (5)
Teva Investigational Site 15544
Boca Raton , Florida
Teva Investigational Site 15549
New York , New York
Teva Investigational Site 15551
New York , New York
Teva Investigational Site 15543
Spokane , Washington
Teva Investigational Site 15555
Tampa , Florida
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
30 Years
Здрави доброволци
Не
Начална дата
30.09.2025
Крайна дата
17.05.2029
Регистрационен номер
NCT07197866
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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