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: 0
• Participant gender: All

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: 4-Aminopyridine

Criteria

Key Inclusion Criteria:

• MS patients with any disease subtype who are ≥18 years of age and must have been newly prescribed Fampyra but not yet started the treatment.

• Patients who are willing and able to provide written informed consent.

Key Exclusion Criteria:

• None

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.