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)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, observational study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FAMPRIDINE
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Short description of the study population:
  To be eligible to participate in this observational study, patients must fulfil the following eligibility criteria at the time of Enrollment:; 1. Patients who have been newly prescribed Fampyra according to the terms of the marketing authorization, but who have not yet started treatment with Fampyra.; 2. Patients who are willing and able to provide written informed consent.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  4734

Study design details

• Main study objective:
  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.
• Outcomes:
  • Number of Participants with Adverse Events, • Utilization patterns of Fampyra in Routine Clinical Practice• Effectiveness of risk minimization measures• Change from Baseline in Physician’s Clinical Global Impression of Improvement (CGI-I) of Walking Ability• Participants’ Assessment of Physical and Psychological Impact of Multiple Sclerosis Using the Multiple Sclerosis Impact Scale-29 Items (MSIS-29)
• Data analysis plan:
  Statistical analyses will be exploratory and descriptive in nature.