Acorda Therapeutics, Inc. (ACOR) announced top line results from a post-marketing commitment study assessing a 5mg dose of dalfampridine-ER to improve walking in people with multiple sclerosis, or MS. The study failed to confirm efficacy of the 5mg dose.
According to the company, the study randomized 430 participants across three treatment arms - placebo, 5 mg or the currently marketed dose of 10 mg of dalfampridine-ER, twice daily. Baseline characteristics were measured at a single visit after randomization, following a qualifying screening visit. Study drug was then given for 4 weeks. Participants returned after 2 weeks on study drug for interim measurements (Visit 2) and again at 4 weeks (Visit 3).
Acorda noted that the primary outcome was the change in walking speed (feet/second) on the Timed 25-Foot Walk test at Visit 3, measured at the time of peak plasma drug concentration, versus baseline. Improvements in the primary outcome for the 5 mg dose and the 10 mg dose at Visit 3 were not statistically significant compared to placebo, the company added.
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