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 Type
OBSERVATIONAL
Enrollment
4,734
Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study.
Research Site
Ciudad Autonoma de Buanos Aires, Buenos Aires, Argentina
Research Site
Rosario, Santa Fe Province, Argentina
Research Site
Buenos Aires, Argentina
Research Site
Córdoba, Argentina
Research Site
Salta, Argentina
Research Site
Number of Participants with Adverse Events
Time frame: Day 1 up to one year
Utilization patterns of Fampyra in Routine Clinical Practice
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.
Time frame: Day 1 up to one year
Effectiveness of risk minimization measures
Variables to be characterized may include demographics, medical history, reasons for Fampyra use, dose deviation from local Fampyra label and overdoses.
Time frame: Day 1 up to one year
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
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.
Time frame: Baseline, 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)
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.
Time frame: Baseline, Months 3, 6, 9, 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Burnaby, British Colombia, Canada
Research Site
Fredericton, New Brunswick, Canada
Research Site
Brampton, Ontario, Canada
Reasearch Center
London, Ontario, Canada
Research Site
London, Ontario, Canada
...and 154 more locations