Acorda has stopped development of dalfampridine to treat post-stroke walking difficulties (PSWD), due to an overall lack of clinically meaningful efficacy.
The dalfampridine Phase 2 study’s (Milestone) primary outcome was the proportion of participants who reached at least a 20% improvement on the Two Minute Walk Test (2MinWT) at week 12 compared to baseline. Of the 368 participants, 19% of those who received 10mg twice daily, and 14% who received 7.5mg twice daily of dalfampridine displayed a ≥20% improvement in the 2MinWT at Week 12 compared to baseline. Thirteen-point-five percent in the placebo group displayed an improvement of ≥20.
Dalfampridine was well-tolerated in the study among the post-stroke population. The most common side effects reported were falls (10mg: 10.7%, 7.5mg: 9.5%, placebo: 5.6%), urinary tract infections (10mg: 9.0%, 7.5mg: 6.3%, placebo: 2.4%), dizziness (10mg: 3.3%, 7.5mg: 7.9%, placebo: 2.4%), and fatigue(10mg: 2.5%, 7.5 mg: 3.2%, placebo: 6.3%).
“We are disappointed by this outcome. The study indicated there was activity related to walking in people with PSWD, as suggested by the prior Phase 2 study, but overall this was not sufficiently clinically meaningful,” said Ron Cohen, MD, President and CEO of Acorda.
For more information visit Acorda.com.