Overview

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

Status:
Completed
Trial end date:
2019-02-08
Target enrollment:
Participant gender:
Summary
The 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).
Details
Lead Sponsor:
Biogen
Treatments:
4-Aminopyridine