Company Halts Development of Post-Stroke Walking Difficulty Therapy

The development was stopped after the treatment failed to show clinically meaningful efficacy
The development was stopped after the treatment failed to show clinically meaningful efficacy

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. 

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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.

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