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Fampridine · LIBERATE

An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice

Ensayo de BIOGEN INC. en Esclerosis multiple.

Más ensayos de: Esclerosis múltiple.

Fase

no aplica

Estado

Completado

Participantes

4.734

previstos

Centros

164

Fin del objetivo primario

feb 2019

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en abr 2012.

Qué mide

Numero de participantes con acontecimientos adversos (Day 1 up to one year) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to collect additional safety data including the incidence rate of seizure and other specific Adverse Events (AEs) of interest from participants taking Fampyra in routine clinical practice. The secondary objectives of this study are to characterize utilization patterns of Fampyra in routine clinical practice, to assess the effectiveness of risk minimization measures as described in the risk management plan for Fampyra, to assess the change over time in participant self-reported evaluation of the physical and psychological impact of Multiple Sclerosis (MS) while taking Fampyra and to assess the change over time in physician assessment of walking ability in participants taking Fampyra (MS participants only).

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01480063), actualizada en jun 2019.