Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced data from a Phase 2 proof-of-concept study of dalfampridine extended release tablets, 10 mg (dalfampridine-ER) in people with post-stroke deficits. In the study, treatment with dalfampridine-ER was well-tolerated and improved walking, as measured by the Timed 25-Foot Walk test (T25FW). The data were presented at the American Neurological Association 2013 Annual Meeting, being held in New Orleans. Top-line data from this study were disclosed by the Company in April 2013.
Post-stroke deficits refer to chronic neurological deficits, such as impaired walking, 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.
“In this proof-of-concept clinical trial of dalfampridine-ER in post-stroke deficits, we were encouraged to see a clear signal for improved walking in this population, consistent with the preclinical data. More than half of the seven million stroke survivors in the United States have walking impairment, but there are no approved medications to address this problem,” said Enrique Carrazana, M.D., Acorda’s Chief Medical Officer. “Based on the strength of the data, we are planning a larger clinical trial to further assess dalfampridine’s safety and tolerability, and potential effect on walking impairment in people with post-stroke deficits.”
The primary goals of the proof-of-concept study were to assess safety and tolerability, as well as to explore various efficacy measures. This study included 83 participants who had experienced an ischemic stroke at least six months prior to treatment and had chronic motor deficits. The average in the study was 10.4 years post-stroke, and the range was up to 35 years. As part of the crossover design, participants received either dalfampridine-ER or placebo twice daily for 14 days (Period 1), followed by a one 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.