- Title
- Improved patient-reported health impact of multiple sclerosis: the ENABLE study of PR-fampridine
- Creator
- MacDonell, Richard; Nagels, Guy; Wang, Ping; Yeh, Michael; Hovenden, Maria; Soelberg Sørensen, Per; Laplaud, David-Axel; Pozzilli, Carlo; de Jong, Brigit; Martins da Silva, Ana; Nicholas, Richard; Lechner-Scott, Jeannette; Gaebler, Julia A.; Agarwal, Sonalee
- Relation
- Multiple Sclerosis Journal Vol. 22, Issue 7, p. 944-954
- Publisher Link
- http://dx.doi.org/10.1177/1352458515606809
- Publisher
- Sage
- Resource Type
- journal article
- Date
- 2016
- Description
- Background: Multiple sclerosis (MS) is a debilitating disease that negatively impacts patients' lives. Objective: 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. Methods: 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. Results: 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. Conclusion: PR-fampridine improved patient-perceived physical and psychological health impact of MS measured in a real-life setting.
- Subject
- fampridine; quality of life; patient-reported outcome; multiple sclerosis
- Identifier
- http://hdl.handle.net/1959.13/1320181
- Identifier
- uon:24084
- Identifier
- ISSN:1352-4585
- Language
- eng
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