A double-blind, randomized, controlled study of two dose strengths of dalfampridine extended release on walking deficits in ischemic stroke.

ABSTRACT: BACKGROUND:Stroke-induced ischemia affects both cortex and underlying white matter. Dalfampridine extended release tablets (D-ER) enhance action potential conduction in demyelinated axons, which may positively affect post-stroke recovery. OBJECTIVE:Based on promising preliminary data, we compared efficacy of D-ER administered at 7.5?mg or 10?mg with placebo on post-stroke ambulation. Primary study outcome (response) was a ?20% increase on the 2-minute walk test (2?MinWT) at 12 weeks after first drug administration. METHODS:This was a multicenter, randomized, placebo-controlled, 3-arm, parallel-group, safety and efficacy trial. After obtaining baseline measures of 2?MinWT, Walk-12, and Timed Up and Go, subjects entered a 2-week, single-blind placebo run-in period and were randomized 1:1:1 to receive 7.5?mg D-ER, 10?mg D-ER, or placebo, dosed twice-daily for 12 weeks. Follow-up evaluations occurred at weeks 14 and 16 when subjects were off study drug. RESULTS:The study was terminated early with 377 of planned 540 patients enrolled, due to no treatment effect. At week 12, mean increase in distances walked in 2 minutes were similar among the 3 study groups (14.9±40.0 feet; 19.4±39.6 feet; and 20.4±38.3 feet for placebo, 7.5?mg D-ER, and 10?mg D-ER, respectively). The proportion of subjects who showed ?20% improvement on 2?MinWT at week 12 was 13.5%, 14.0%, and 19.0%, for placebo, 7.5?mg D-ER, and 10?mg D-ER, respectively; these were nonsignificant changes from baseline for all groups. CONCLUSIONS:D-ER at either a 7.5-mg or 10-mg dose did not significantly increase performance on the 2?MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment. (Clinical Trial # NCT02271217).

SUBMITTER: Page SJ 

PROVIDER: S-EPMC7592666 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature