Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial
View
or print this bulletin in its original format.
Medical Update Memo
January 29, 2010
Summary
Clinical studies suggested that fampridine (4-aminopyridine) improves motor function in people with multiple sclerosis. This phase III study assessed efficacy and safety of oral, sustained-release fampridine in people with ambulatory deficits due to multiple sclerosis. Lancet. 2009 Feb 28;373(9665):697-8.
Details
301 patients with any type of multiple sclerosis were enrolled in a randomised, multicentre, double-blind, controlled phase III trial and were treated for14 weeks with either fampridine (10 mg twice daily; n=229) or placebo (n=72), using a computer-generated sequence stratified by centre. The breakdown for type of MS was:
| Type of MS |
Number |
% of Study Population |
| Relapsing Remitting |
47 |
31 |
| Primary Progressive |
21 |
13 |
| Secondary Progressive |
77 |
51 |
| Progressive Relapsing |
6 |
6 |
The primary outcome measure was defined as a consistent improvement on timed 25-foot walk. The 12-item multiple sclerosis walking scale was used to validate the clinical significance of the response criterion. Efficacy analyses were based on a modified intention-to-treat population (n=296), which included all patients with any post-treatment efficacy data.
The proportion of timed walk responders was higher in the fampridine treated group (78/224 or 35%) than in the placebo group (6/72 or 8%; p<0.0001). The average change from baseline for treated responders was on 0.5 feet per second over a 25 foot timed walk. Improvement in walking speed in this group was maintained throughout the treatment period. Timed walk responders showed greater improvement in 12-item multiple sclerosis walking scale scores (-6.84, 95% CI -9.65 to -4.02) than timed walk non-responders (0.05, -1.48 to 1.57; p=0.0002). Safety data were consistent with previous studies.
Of the patients in the treated group, 7% reported 1 or more serious adverse events. These included but were not limited to; urinary tract infection, severe anxiety, sepsis related to a community acquired pneumonia, and seizure.
Fampridine improved walking ability in some people with multiple sclerosis. This improvement was associated with a reduction of patients' reported ambulatory disability.
National Research and Programs
Offert en français.
Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary health
agency and does not approve, endorse or recommend any specific product or therapy,
but provides information to assist individuals in making their own decisions.
Back
to top  |
