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

NCT01480063 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4734

Last updated 2019-06-05

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Fampridine

Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-16
Primary Completion
2019-02-08
Completion
2019-02-08

Countries

  • Argentina
  • Canada
  • Czechia
  • France
  • Germany
  • Ireland
  • Israel
  • Lebanon
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • United Arab Emirates

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01480063 on ClinicalTrials.gov