Acorda Therapeutics reported positive results from its Phase III trial of Fampridine-SR on walking in people with multiple sclerosis (MS). Statistical significance was achieved on all three efficacy criteria defined in the special protocol assessment by the FDA.
The trial found that 34.8% of people taking Fampridine-SR had a consistent improvement in walking speed, the study’s primary outcome, compared to 8.3% of those taking placebo. This was measured by the timed 25-ft walk (p<0.001). The effect was maintained throughout the 14-week treatment period (p<0.001). This increased response rate was seen across all four major types of MS.
There was also a statistically significant improvement in the 12-item MS walking scale for walking responders versus nonresponders (p<0.001).
The average increase in walking speed over the treatment period compared to baseline was 25.2% for the drug group vs. 4.7% for the placebo group.
In addition, statistically significant increases in leg strength were seen in both the Fampridine-SR timed walk responders (p<0.001) and the Fampridine-SR timed walk nonresponders (p=0.046) compared to placebo.