PHILADELPHIA – Dalfampridine was shown to improve walking ability and balance in patients with progressive and relapsing-remitting multiple sclerosis, according to data presented at the annual meeting of the American Academy of Neurology.
For a more integrated assessment of dalfampridine’s effect on patients’ walking abilities over a longer period of time, Dr. Jan Lycke of the University of Gothenberg (Sweden) and his associates randomized 132 patients with MS and an Expanded Disability Status Scale score of 4-7 to 24 weeks of dalfampridine or placebo in the double-blind trial called MOBILE (Exploratory Study to Assess the Effect of Fampridine on Walking Ability and Balance in Patients With Multiple Sclerosis).
The study was conducted in Canada and European countries with prolonged-release fampridine (Fampyra), known as dalfampridine (Ampyra) in the United States. Dalfampridine was approved in the United States in 2010 as the first oral medication for MS based on its ability to improve walking speed, although it has since been associated with seizures in some patients in doses above the recommended 10 mg twice daily.
The 68 patients who took dalfampridine 10 mg twice daily and the 64 in the placebo group were assessed using the Multiple Sclerosis Walking Scale-12 (MSWS-12), the Multiple Sclerosis Impact Scale-29 (MSIS-29), the Timed Up and Go (TUG), and the Berg Balance Scale (BBS).
Nearly half of patients in the treatment arm (49% vs. 28.1% on placebo; P = .015) reached or exceeded the clinically meaningful threshold of at least an 8-point improvement on the MSWS-12, beginning in weeks 2-4 and then sustained throughout the study period, Dr. Lycke said.
"There was a median improvement change in the [TUG] measurement of at least 10%-15% [47.1% vs. 30.2% placebo; P = .026], which was sustained throughout the treatment period," he told the audience. A 15% or greater improvement of the TUG score was considered clinically meaningful. This cohort had similar improvement rates over baseline for BBS scores, he said.
Dalfampridine treatment led to greater median treatment differences from baseline to week 24, compared with placebo, on the MSWS-12 (–3.27; 95% confidence interval, –7.59-1.19), TUG speed (9.64%; 95% CI, 2.05%-16.48%), BBS score (1.50; 95% CI, 0.00-2.93), and MSIS-29 physical subscale (–3.30; 95% CI, –7.68-0.98). After treatment discontinuation at week 24, the measurements returned to baseline levels.
No seizures were recorded during the trial, Dr. Lycke said.
The trial was sponsored by Biogen Idec, which holds a licensing agreement with Acorda Therapeutics to market prolonged-released fampridine outside of the United States. Dr. Lycke had numerous disclosures, including Biogen Idec, Genzyme, Novartis, and Teva.
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