An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice (LIBERATE)
|ClinicalTrials.gov Identifier: NCT01480063|
Recruitment Status : Active, not recruiting
First Posted : November 28, 2011
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Drug: Fampridine|
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|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)|
|Actual Study Start Date :||April 16, 2012|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Fampyra administered as prescribed in routine clinical practice.
Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study.
- Number of Participants with Adverse Events [ Time Frame: Day 1 up to one year ]
- Utilization patterns of Fampyra in Routine Clinical Practice [ Time Frame: Day 1 up to one year ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480063
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|Study Director:||Medical Director||Biogen|