A Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE)
Overview
- Phase
- Not Applicable
- Intervention
- Fampridine
- Conditions
- Multiple Sclerosis
- Sponsor
- Biogen
- Enrollment
- 4734
- Locations
- 5
- Primary Endpoint
- Number of Participants with Adverse Events
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
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.
Exclusion Criteria
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Arms & Interventions
Fampyra
Fampyra administered as prescribed in routine clinical practice.
Intervention: Fampridine
Outcomes
Primary Outcomes
Number of Participants with Adverse Events
Time Frame: Day 1 up to one year
Secondary Outcomes
- Utilization patterns of Fampyra in Routine Clinical Practice(Day 1 up to one year)
- Effectiveness of risk minimization measures(Day 1 up to one year)
- Participants' Assessment of Physical and Psychological Impact of Multiple Sclerosis Using the Multiple Sclerosis Impact Scale-29 Items (MSIS-29)(Baseline, Months 3, 6, 9, 12)
- Change from Baseline in Physician's Clinical Global Impression of Improvement (CGI-I) of Walking Ability Assessed Whenever the Multiple Sclerosis Participant is Seen by the Neurologist(Baseline, Day 1 up to one year)