|
ИСТИНА |
Войти в систему Регистрация |
Интеллектуальная Система Тематического Исследования НАукометрических данных |
||
Amifampridine phosphate (Firdapse®) is effective and safe in a phase 3 clinical trial in LEMSстатья
Информация о цитировании статьи получена из
Web of Science,
Scopus
Статья опубликована в журнале из списка Web of Science и/или Scopus
Дата последнего поиска статьи во внешних источниках: 6 сентября 2016 г.
- Авторы: Oh Shin J., Shcherbakova Natalya, Kostera-Pruszczyk Anna, Alsharabati Mohammad, Dimachkie Mazen, Blanco Jose Munoz, Brannagan Thomas, Lavrnić Dragana, Shieh Perry B., Vial Christophe
- Журнал: Muscle and Nerve
- Том: 53
- Номер: 5
- Год издания: 2016
- Издательство: John Wiley & Sons Inc.
- Местоположение издательства: United States
- Первая страница: 717
- Последняя страница: 725
- DOI: 10.1002/mus.25070
- Аннотация: OBJECTIVE: We evaluated the efficacy and safety of amifampridine phosphate (Firdapse(®)) for symptomatic treatment in Lambert-Eaton myasthenic syndrome (LEMS). METHODS: Phase 3, randomized, double-blind, study. Patients were treated initially with amifampridine phosphate for 7-91 days, followed by randomization to continue amifampridine phosphate for 14 days or placebo (7-day taper, 7-day placebo). The primary efficacy endpoints were changes from baseline at day 14 in Quantitative Myasthenia Gravis and Subject Global Impression scores. RESULTS: The coprimary efficacy end points and 1 of the secondary efficacy end points were met, showing a significant benefit of aminfampridine phosphate over placebo at Day 14. All 5 primary, secondary, and tertiary endpoints achieved statistical significance at Day 8. Amifampridine phosphate was well tolerated; the most common adverse events were oral and digital paresthesias, nausea, and headache. CONCLUSIONS: This study provides Class I evidence of efficacy of amifampridine phosphate as a symptomatic treatment for LEMS.
- Добавил в систему: Щербакова Наталья Ивановна