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Walking, quality of life, and safety with prolonged-release fampridine treatment in clinical practice: Interim results of the liberate study

      Background: Impaired walking is common in multiple sclerosis (MS) and negatively impacts patients' lives.
      Objective: To collect long-term, real-life data in MS patients treated with prolonged-release (PR) fampridine (dalfampridine extended-release in the United States) in clinical practice.
      Methods: LIBERATE is an observational, ongoing study enrolling patients initiating treatment with PR-fampridine 10 mg twice daily in routine clinical practice. Endpoints include patient-perceived impact of MS measured by the Multiple Sclerosis Impact Scale-29 physical subscale (MSIS-29 PHYS) and physician-assessed Clinical Global Impression of Improvement (CGI-I) of walking ability. Safety was also assessed. Patient and/or institutional review board approval was obtained, as necessary. Interim results from France and Germany are reported.
      Results: As of July 2014, 1803 patients enrolled in Germany and France of whom 1155 were dosed and completed 6-month follow up (n = 820 remained on-treatment; n = 335 had discontinued treatment but remained on study as patients “off-treatment”). A greater (mean [SD]) improvement in the MSIS-29 PHYS score from baseline to month 6 was observed among patients on-treatment (−8.57 [16.92]; n = 633) versus patients off-treatment (−2.59 [16.85]; n = 238). CGI-I scores improved in 70.1%, remained stable in 22.5%, and worsened in 7.4% of patients on-treatment (n = 582) at Month 6, versus 12.0%, 66.1% and 21.9% of patients off-treatment (n = 192), respectively. The most common adverse events were insomnia (n = 94 [5.2%]), vertigo (n = 64 [3.5%]) and headache (n = 62 [3.4%]).
      Conclusions: PR-fampridine was well tolerated and was associated with improved MSIS-29 PHYS scores and walking ability from baseline over 6 months in clinical practice in Germany and France.