An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice (LIBERATE)
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).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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)|
- Number of Participants with Adverse Events [ Time Frame: Day 1 up to one year ] [ Designated as safety issue: Yes ]
- Utilization patterns of Fampyra in Routine Clinical Practice [ Time Frame: Day 1 up to one year ] [ Designated as safety issue: No ]Variables to be characterized include reason for Fampryra use, dose and duration of use, dosing deviations from local Fampyra label, and reasons for dosage changes.
- Effectiveness of risk minimization measures [ Time Frame: Day 1 up to one year ] [ Designated as safety issue: No ]Variables to be characterized may include demographics, medical history, reasons for Fampyra use, dose deviation from local Fampyra label and overdoses.
- 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 [ Time Frame: Baseline, Day 1 up to one year ] [ Designated as safety issue: No ]The Clinical Global Impression-Improvement (CGI-I) scale is a 7-point scale that requires the clinician to rate the improvement or worsening of the overall walking ability of the patient.
- Participants' Assessment of Physical and Psychological Impact of Multiple Sclerosis Using the Multiple Sclerosis Impact Scale-29 Items (MSIS-29) [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
Fampyra administered as prescribed in routine clinical practice.
Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480063
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|Study Director:||Medical Director||Biogen|