Please use this identifier to cite or link to this item: http://ahro.austin.org.au/austinjspui/handle/1/17428
Title: Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine.
Authors: Macdonell, Richard A L;Nagels, Guy;Laplaud, David-Axel;Pozzilli, Carlo;de Jong, Brigit;Martins da Silva, Ana;Nicholas, Richard;Lechner-Scott, Jeannette;Gaebler, Julia A;Agarwal, Sonalee;Wang, Ping;Yeh, Michael;Hovenden, Maria;Soelberg Sørensen, Per
Affiliation: Department of Neurology, Austin Health, The University of Melbourne, Heidelberg, Victoria, Australia
National Multiple Sclerosis Center Melsbroek and Center for Neurosciences, Vrije Universiteit Brussel, Belgium
Centre Hospitalier Universitaire de Nantes, Hôpital G. et R. Laennec, France
The Department of Neurology and Psychiatry, Sapienza University, Italy
Radboud University Medical Center, Nijmegen and the Neurology Department of Jeroen Bosch Hospital, The Netherlands
Neurosciences Department, Hospital Santo António-Centro Hospitalar do Porto, Portugal
Imperial College, UK
Hunter Medical Research Institute, The University of Newcastle, Australia
Biogen, Cambridge, MA, USA
Excel Scientific Solutions, Southport, CT, USA
Danish Multiple Sclerosis Center, Copenhagen University Hospital Rigshospitalet, Denmark
Issue Date: Jun-2016
EDate: 2015-10-07
Citation: Multiple sclerosis (Houndmills, Basingstoke, England) 2016; 22(7): 944-954
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.
URI: http://ahro.austin.org.au/austinjspui/handle/1/17428
DOI: 10.1177/1352458515606809
PubMed URL: 26447066
Type: Clinical Trial, Phase IV
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Subjects: Fampridine
multiple sclerosis
patient-reported outcome
quality of life
Appears in Collections:Journal articles

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