An observational study in Multiple Sclerosis, sponsored by Biogen. Completed at 168 sites in 13 countries. Per ClinicalTrials.gov, last updated 2019-06-05.
Sponsored by Biogen · Observational
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).
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 4,734 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
This post marketing study will be carried out by neurologists in routine clinical settings.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Fampyra administered as prescribed in routine clinical practice.
Drug: Fampridine
Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study.
Also known as: Ampyra, dalfampridine, Fampyra, BIIB041, fampridine prolonged-release tablets
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
Showing the first 100 of 168 sites across 13 countries.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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