In an article published in this week´s edition of The Lancet, the findings of a Phase III study, indicate that the drug called fampridine improves walking ability in some multiple sclerosis (MS) patients and seems well accepted by patients with all disease course types of MS.
There are currently few therapeutic options to complement physiotherapy for MS patients who´s mobility progressively declines. Improvement in visual function, strength, walking ability, fatigue and endurance could be the results of fampridine treatment for MS patients. However, the effectiveness and safety of the drug in MS patients is still uncertain.
Professor Andrew Goodman, University of Rochester Medical Center, New York, USA and team, conducted a randomized trial test in order to obtain additional information in measuring the effectiveness and safety of slow-release fampridine drug on walking capacity and leg strength. The research included patients with any disease course of MS who could complete two trials of the timed 25-foot walk (T25FW), in thirty-three centers in the USA and Canada.
For fourteen weeks, 301 patients from 18 to 70 years of age were given fampridine (10mg dose) or a placebo at random, both twice daily. After two weeks, then every four weeks for fourteen weeks, patients were evaluated for walking speed measured with the T25FW. The patients´ perception of the difficulties in walking and their consequences were measured by the 12-item multiple sclerosis walking scale (MSWS-12).
The number of timed walk responders (patients with faster walking speed in the last three to four evaluations while in treatment compared with the highest speed while not in treatment) was of 35 percent (78/224) in the fampridine treatment group, and of only 8 percent (6/72) in the placebo group, according to the findings.
The progress in walking speed among the patients receiving fampridine was of 25.5 percent compared to 4.7 percent for placebo. The fampridine-treated group also had higher improvement in leg strength than the placebo group. In all the 12 items on the MSW scale, timed walk responders reported a higher improvement than timed walk non-responders, confirming progress in patient´s perception.
The researchers report that due to adverse events, 5 percent (11) in the fampridine group (including 4 percent (8) requiring treatment) had to be pulled out of the study. Focal seizure and severe anxiety are the only two adverse events that were thought to be linked to the drug. The authors note that a connection between higher risks of seizure and fampridine was established in prior studies.
“Treatment with fampridine produces clinically meaningful improvement in walking ability in some people with multiple sclerosis, irrespective of disease course type or concomitant treatment with immunomodulators,” the authors write in conclusion.
Alan Thompson, University College London, UK, and Chris Polman, VU Medical Centre, Amsterdam, in a supplementary note say they accept the findings but add that: “Better understanding of the treatment profile, in terms of the full functional treatment effect and identification of those most likely to respond, is needed to allow for effective implementation in treatment regimens for multiple sclerosis.”
Written by Stephanie Brunner (B.A.)