title: Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine.
abstract: Multiple sclerosis (MS) is a debilitating disease that negatively impacts patients' lives.
  
  
  
  ENABLE assessed the effect of long-term prolonged-release (PR) fampridine (dalfampridine extended release in the United States) treatment on patient-perceived health impact in patients with MS with walking impairment.
  
  
  
  ENABLE was a 48-week, open-label, Phase 4 study of PR-fampridine 10 mg twice daily. Patients who showed any improvement in Timed 25-Foot Walk walking speed at weeks 2 and 4 and any improvement in 12-item MS Walking Scale score at week 4 remained on treatment. The primary endpoint was change from baseline in 36-Item Short-Form Health Survey (SF-36) physical component summary (PCS) score.
  
  
  
  At week 4, 707/901 (78.5%) patients met the criteria to remain on treatment. Patients on treatment demonstrated significant and clinically meaningful improvements in SF-36 PCS scores from baseline (mean change (95% confidence interval)) to week 12 (4.30 (3.83, 4.78); p < 0.0001), week 24 (3.75 (3.23, 4.27); p < 0.0001), week 36 (3.46 (2.95, 3.97); p < 0.0001), and week 48 (3.24 (2.72, 3.77); p < 0.0001). Significant improvements from baseline were also demonstrated in secondary health measures in patients on treatment.
  
  
  
  PR-fampridine improved patient-perceived physical and psychological health impact of MS measured in a real-life setting.
authors.affiliation: Department of Neurology, Austin Health, University of Melbourne, Australia Richard.Macdonell@austin.org.au.
authors.forename: Richard
authors.initials: R
authors.lastname: Macdonell
authors.affiliation: National Multiple Sclerosis Center Melsbroek and Center for Neurosciences, Vrije Universiteit Brussel, Belgium.
authors.forename: Guy
authors.initials: G
authors.lastname: Nagels
authors.affiliation: Centre Hospitalier Universitaire de Nantes, Hôpital G. et R. Laennec, France.
authors.forename: David-Axel
authors.initials: DA
authors.lastname: Laplaud
authors.affiliation: The Department of Neurology and Psychiatry, Sapienza University, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Pozzilli
authors.affiliation: Radboud University Medical Center, Nijmegen and the Neurology Department of Jeroen Bosch Hospital, The Netherlands.
authors.forename: Brigit
authors.initials: B
authors.lastname: de Jong
authors.affiliation: Neurosciences Department, Hospital Santo António-Centro Hospitalar do Porto, Portugal.
authors.forename: Ana
authors.initials: A
authors.lastname: Martins da Silva
authors.affiliation: Imperial College, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Nicholas
authors.affiliation: Hunter Medical Research Institute, The University of Newcastle, Australia.
authors.forename: Jeannette
authors.initials: J
authors.lastname: Lechner-Scott
authors.affiliation: Biogen, Cambridge, MA, USA.
authors.forename: Julia A
authors.initials: JA
authors.lastname: Gaebler
authors.affiliation: Biogen, Cambridge, MA, USA.
authors.forename: Sonalee
authors.initials: S
authors.lastname: Agarwal
authors.affiliation: Biogen, Cambridge, MA, USA.
authors.forename: Ping
authors.initials: P
authors.lastname: Wang
authors.affiliation: Biogen, Cambridge, MA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Yeh
authors.affiliation: Excel Scientific Solutions, Southport, CT, USA.
authors.forename: Maria
authors.initials: M
authors.lastname: Hovenden
authors.affiliation: Danish Multiple Sclerosis Center, Copenhagen University Hospital Rigshospitalet, Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Soelberg Sørensen
mesh_terms: D015761:4-Aminopyridine / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D001315:Australia; D003692:Delayed-Action Preparations; D004185:Disability Evaluation; D005060:Europe; D017079:Exercise Tolerance / Q000187:drug effects; D005260:Female; D005684:Gait; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D000071066:Patient Reported Outcome Measures; D026902:Potassium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D020127:Recovery of Function; D013997:Time Factors; D016896:Treatment Outcome; D016138:Walking; D055815:Young Adult
chemical_list: D003692:Delayed-Action Preparations; D026902:Potassium Channel Blockers; D015761:4-Aminopyridine
keywords: Fampridine; multiple sclerosis; patient-reported outcome; quality of life