Extended-Release Dalfampridine Treats Post-Stroke Deficit
Phase II data presented at neurology conference (October 14)
Positive data have been reported from a phase II proof-of-concept study of dalfampridine extended-release tablets (dalfampridine-ER, Acorda Therapeutics) in people with post-stroke deficits.
In the study, treatment with dalfampridine-ER 10 mg was well-tolerated and improved walking, as measured by the Timed 25-Foot Walk (T25FW) test. The new data were presented at the American Neurological Association 2013 Annual Meeting, being held in New Orleans.
Post-stroke deficits refer to chronic neurological deficits, such as impaired walking and impaired motor and/or sensory function, that persist in people who have had a stroke. There are currently no pharmacologic therapies indicated to improve function in people with post-stroke deficits.
The study’s primary goals were to assess the safety and tolerability of dalfampridine-ER in people with post-stroke deficits, as well as to explore various efficacy measures. The study included 83 participants who had experienced an ischemic stroke at least 6 months prior to treatment and who had chronic motor deficits. The average duration of post-stroke deficit was 10.4 years.
As part of the study’s crossover design, the participants received either dalfampridine-ER or placebo twice daily for 14 days (period 1), followed by a 1-week wash-out period in which all participants received placebo. This was followed by a second 14-day treatment period (period 2), during which participants received the alternate treatment.
The primary focus of the exploratory efficacy analyses was walking, as measured by the T25FW test. In the full crossover analysis, which included all T25FW data from both treatment periods, there was a significant increase in walking speed while participants were taking dalfampridine-ER compared with placebo (P = 0.027).
Dalfampridine is the active ingredient in Ampyra (dalfampridine) extended-release tablets, 10 mg — a treatment to improve walking in patients with multiple sclerosis. Dalfampridine extended-release tablets have not been evaluated by the FDA for the treatment of post-stroke deficits.
Source: Acorda Therapeutics; October 14, 2013.