Category: Cross-Cutting; Stroke
Objective : To compare efficacy of dalfanpridine-extended release(DALF-ER) administered at 7.5mg or 10 mg with a placebo tablet on post-stroke ambulation.
Design : Double Blinded, Multicenter, Randomized Controlled Study
Setting : multicenter, randomized, placebo-controlled, three-arm, parallel-group, safety, efficacy trial.
Participants (or Animals, Specimens, Cadavers) : Of the 575 subjects screened for eligibility, 156 were screen failures and 419 were enrolled into the single-blind placebo run-in period, of which 377 were randomized into the double-blind treatment period.
Interventions : Subjects first participated in a 2-week, single-blind placebo run-in period, in which they were instructed to take study drug approximately every 12 hours, until Week 0, when subjects were randomized at a ratio of 1:1:1 to receive 7.5 mg DALF-ER, 10 mg DALF-ER, or a matching placebo tablets, dosed twice daily for 12 weeks. Follow-up evaluations occurred at week 14 and 16 when subjects were off study drug.
Main Outcome Measure(s) : The 2MinWT, the Walk-12, and Timed Up and Go (TUG), administered before a 2-week run-in period, as well as during two followup periods after the intervention had concluded.
Results : The study was terminated early, with 377 of the planned 540 patients enrolled.. At Week 12 the mean distances walked in 2 minutes were similar among the three study conditions (14.9 + 40.0; 19.4 + 39.6 feet; 20.4 + 38.3 feet for placebo, 7.5 mg DALF-ER, and 10 mg DALF-ER, respectively). The proportion of subjects who showed at least a 20% improvement on the 2 minute walk test at12 weeks was 13.5%, 14.0% and 19.0%, for placebo, 7.5 mg DALF-ER, 10 mg DALF-ER, respectively; these were nonsignificant changes from baseline for all groups. Nonsignfiicant changes were seen on the Walk-12 and TUG.
Conclusions : DALF-ER at either a 7.5mg or 10 mg dose does not significantly increase performance on the 2MinWT in stroke survivors with gait impairment.
Stephen Page– Professor, The Ohio State University College of Medicine, Columbus, Ohio