An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Fampridine

• Registration Number: NCT01480063
• Lead Sponsor: Biogen

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-23
• Study First Submitted QC: 2011-11-25
• Study First Posted: 2011-11-28
• Study Start: 2012-04-16
• Primary Completion: 2019-02-08
• Study Completion: 2019-02-08
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4734

Inclusion Criteria

• MS patients with any disease subtype who are ≥18 years of age and must have been newly prescribed Fampyra but not yet started the treatment.
• Patients who are willing and able to provide written informed consent.

Key

Exclusion Criteria

• None

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fampyra	Fampridine	Fampyra administered as prescribed in routine clinical practice.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	Day 1 up to one year

Secondary Outcome Measures

Name	Time	Method
Utilization patterns of Fampyra in Routine Clinical Practice	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	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.
Participants' Assessment of Physical and Psychological Impact of Multiple Sclerosis Using the Multiple Sclerosis Impact Scale-29 Items (MSIS-29)	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.
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	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.

Trial Locations

Locations (5)

Site Research; 🇪🇸 Bilbao, Vizcaya, Spain

Research site; 🇪🇸 San Cristobal de La laguna, Tenerife, Spain

Reasearch Center; 🇨🇦 London, Ontario, Canada

Research Site; 🇦🇪 Dubai, United Arab Emirates

Rsearch Site; 🇳🇱 Zutphen, Netherlands