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.
Other outcome metrics included changes in mobility scores (Timed Up and Go speed), in the physical impact of MS (MSIS-29 physical subscale), body balance (Berg Balance Scale), and manual ability (ABILHAND).
Results showed that after the 24-week treatment, a higher proportion of Ampyra-treated patients (136 out of 315; 43.2%) had a clinically meaningful improvement in walking ability as measured by MSWS-12, compared with those given a placebo (107 out of 318; 33.6%).
This translated into an estimated 61% higher odds of patients under treatment with Ampyra getting relief from their walking difficulties.
Ampyra also led to more patients being able to move faster, as measured by TUG scores, and reporting fewer physical limitations as assessed by the MSIS-29 physical scale. Improvements in body balance and manual ability were also seen in patients receiving Ampyra, but they were not statistically significant.
The most common adverse events associated with Ampyra were urinary infection and insomnia.
Based on the results, the researchers concluded that treatment with Ampyra “was associated with a greater likelihood of walking-impaired participants with MS experiencing clinically meaningful improvements in self-reported walking ability over 24 weeks.”
But researchers caution that while one of Ampyra’s benefits is its rapid action, those effects are lost when treatment stops . “This means that patients must be watchful” when stopping Ampyra “as their functioning can worsen soon after,” they stated.