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.