Multiple Sclerosis Clinical Trial
Official title:
Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis
Fampyra, a voltage-dependent potassium channel blocker, is indicated for the improvement of
walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). The
medicinal product has been authorized under a so-called "conditional approval" scheme. This
means that further evidence on this medicinal product is awaited and this study aims to
assess the effect of Fampyra, administered according to standard clinical practice, on
cognition, fatigue and quality of life in patients with MS.
This clinical study is a multicenter, prospective, non-interventional, cohort study of MS
patients receiving Fampyra in outpatient setting. Patients will be treated according to the
local prescribing information of the study medication and routine medical practice in terms
of visit frequency and types of assessments performed. The assignment of the patient to this
therapeutic strategy is not decided in advance by the study protocol but falls within current
practice and the prescription of Fampyra is clearly separated from the physician's decision
to include the patient in the current study.
Since this is purely non-interventional study, primary data -which will be obtained
prospectively during the study visits through patients' interview and patient reported
outcomes or as performed per standard clinical practice- will mainly be employed.
The study will take place in Greece. Investigator's decision to prescribe Fampyra (according to the indication for treatment as defined in the summary of product characteristics, SmPC and the current clinical practice), should precede entry into the study. ;
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