Treatment with Ampyra (dalfampridine) for 24 weeks leads to sustained and clinically meaningful improvements in walking ability as reported by multiple sclerosis (MS) patients with gait difficulties, according to a study analyzing results from a Phase 3 trial.
The study, “Assessment of Clinically Meaningful Improvements in Self-Reported Walking Ability in Participants with Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III ENHANCE Trial of Prolonged-Release Fampridine” was published in the journal CNS Drugs.
More than 90 percent of MS patients have difficulty walking, which reduces their independence and negatively affects their quality of life and productivity.
Ampyra (prolonged-release dalfampridine tablets) is an approved MS medication marketed by Acorda Therapeutics in the U.S. It is the first therapy specifically approved to help improve walking in adults with MS. A generic version of Ampyra was made available this year in the U.S. by Mylan. In Europe, the medicine is approved under the brand name Fampyra, being marketed by Biogen.
An international group of researchers involved in the clinical trialto see whether the therapy could improve, in a clinically meaningful way, the walking ability of MS patients based on data from the trial.
ENHANCE was a multinational, randomized, placebo-controlled, Phase 3 study (NCT02219932) to assess whether Ampyra given over a 24-week period could reduce the walking difficulties of MS patients. The study was carried out at several centers in 10 European countries, the U.S., and Russia, and included patients with different MS subtypes.
In total, 636 MS participants, ages 18-70 and with walking difficulties, were randomized to be given either Ampyra tablets 10 mg twice a day (317 patients), or matched placebo (319 patients) for 24 weeks.
The primary endpoint of the trial was the proportion of participants exceeding an eight-point improvement (the predefined threshold for clinically meaningful improvement) on the Multiple Sclerosis Walking Scale (MSWS-12) following the 24 weeks of treatment. MSWS-12 is a patient self-assessment survey based on walking limitations because of MS.
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