Идёт набор NCT06568237
A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: TEV-56286, Placebo.
- Кому может быть актуально
- Состояния в реестре: Multiple System Atrophy. Базовые параметры: 30 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Франция, Германия, Израиль, Италия +3
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Multi-centered, Double-blind, Randomized, Placebo-controlled, Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients With Multiple System Atrophy (TOPAS-MSA)
Обзор
The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286. Another secondary objective is to evaluate the safety and tolerability of TEV-56286. The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.
Подробное описание
We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, Japan, and Serbia.
Вмешательства
- Препарат TEV-56286
TEV-56286 capsules administered orally - Препарат Placebo
Matching placebo administered orally
Первичные конечные точки
- For non-EU: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (excluding item 11) [Срок оценки: Baseline to Week 48]
- For EU: Change From Baseline in the Total UMSARS Score Part I and Part II Combined [Срок оценки: Baseline to Week 48]
Вторичные конечные точки (12)
- For non-EU: Change From Baseline in the Total UMSARS Score (Part I and Part II combined) [Срок оценки: Baseline to Week 48]
- For EU: Change From Baseline in the Modified UMSARS part I score (excluding item 11, item scoring rescaled 0-3) [Срок оценки: Baseline to Week 48]
- Change From Baseline in the UMSARS Part 1 Score [Срок оценки: Baseline to Week 48]
- Change From Baseline in Lateral Ventricle Volume Measured by MRI [Срок оценки: Baseline to Week 48]
- Change From Baseline in the Clinical Global Impression - Severity scale (CGI-S) [Срок оценки: Baseline to Week 48]
- Change From Baseline in the Neurofilament Light Chain (NfL) Concentrations in Cerebrospinal Fluid (CSF) [Срок оценки: Baseline to Week 48]
- Change From Baseline in the Patient Global Impression-Severity Scale (PGI-S) [Срок оценки: Baseline to Week 48]
- Change From Baseline in the Pons volume measured by MRI [Срок оценки: Baseline to Week 48]
- Change From Baseline in the Cerebellar volume measured by MRI [Срок оценки: Baseline to Week 48]
- Change From Baseline in the UMSARS part II score [Срок оценки: Baseline to Week 48]
- Change From Baseline in the UMSARS part IV score [Срок оценки: Baseline to Week 48]
- Change From Baseline in the Two-minute walk test as part of gait assessment [Срок оценки: Baseline to Week 48]
Критерии участия
Критерии включения
- is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria
- is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination
- Females of child bearing potential (CBP) may be included only if they have a negative pregnancy test at the screening and baseline visits
- Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods
- Males who are potentially fertile/reproductively competent (not surgically \[eg, vasectomy\] or congenitally sterile) and their female partners who are of CBP must use, together with their female partners, highly effective birth control methods
- Additional criteria apply; please contact the investigator for more information
Критерии исключения
- has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA
- has participated in another clinical study involving administration of an IMP within 3 months or 5 half-lives (whichever is longer) of this IMP prior to screening
- has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening
- is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study
- has a known hypersensitivity to any components of the IMP
- is of a vulnerable population (eg, people kept in detention or jail)
- participant is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this study
- Additional criteria apply; please contact the investigator for more information
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 19 центров
- Teva Investigational Site 15554 — La Jolla
- Teva Investigational Site 15545 — Los Angeles
- Teva Investigational Site 15547 — Washington D.C.
- Teva Investigational Site 15544 — Boca Raton
- Teva Investigational Site 15555 — Tampa
- Teva Investigational Site 15550 — Chicago
- Teva Investigational Site 15546 — Kansas City
- Teva Investigational Site 15736 — Boston
- … и ещё 11 центров
Испания · 11 центров
- Teva Investigational Site 31328 — Barakaldo
- Teva Investigational Site 31323 — Barcelona
- Teva Investigational Site 31321 — Barcelona
- Teva Investigational Site 31324 — Barcelona
- Teva Investigational Site 31329 — Elche
- Teva Investigational Site 31327 — Madrid
- Teva Investigational Site 31330 — Madrid
- Teva Investigational Site 31331 — Madrid
- … и ещё 3 центра
Германия · 9 центров
- Teva Investigational Site 32823 — Beelitz
- Teva Investigational Site 32818 — Dresden
- Teva Investigational Site 32822 — Düsseldorf
- Teva Investigational Site 32825 — Kassel
- Teva Investigational Site 32826 — Leipzig
- Teva Investigational Site 32824 — Marburg
- Teva Investigational Site 32820 — München
- Teva Investigational Site 32819 — Münster
- … и ещё 1 центр
Япония · 7 центров
- Teva Investigational Site 84140 — Chiba
- Teva Investigational Site 84139 — Fuchū
- Teva Investigational Site 84136 — Gifu
- Teva Investigational Site 84137 — Niigata
- Teva Investigational Site 84138 — Sagamihara
- Teva Investigational Site 84141 — Sanda-shi
- Teva Investigational Site 84135 — Sendai
Италия · 6 центров
- Teva Investigational Site 30299 — Bologna
- Teva Investigational Site 30297 — Catania
- Teva Investigational Site 30298 — Milan
- Teva Investigational Site 30294 — Padova
- Teva Investigational Site 30296 — Roma
- Teva Investigational Site 30295 — Salerno
Франция · 5 центров
- Teva Investigational Site 35290 — Bordeaux
- Teva Investigational Site 35300 — Caen
- Teva Investigational Site 35289 — Marseille
- Teva Investigational Site 35291 — Paris
- Teva Investigational Site 35292 — Toulouse
Израиль · 3 центра
- Teva Investigational Site 80203 — Haifa
- Teva Investigational Site 80215 — Jerusalem
- Teva Investigational Site 80204 — Tel Aviv
Сербия · 1 центр
- Teva Investigational Site 61808 — Belgrade
Идентификаторы
NCT: NCT06568237 · TV56286-NDG-20039 · 2023-505320-54-00