A double-blind, randomized, controlled study of two dose strengths of dalfampridine extended release on walking deficits in ischemic stroke.
Restor Neurol Neurosci
; 38(4): 301-309, 2020.
Article
in En
| MEDLINE
| ID: mdl-32651338
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 7.5âmg or 10âmg with placebo on post-stroke ambulation. Primary study outcome (response) was a ≥20% increase on the 2-minute walk test (2âMinWT) 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 2âMinWT, Walk-12, and Timed Up and Go, subjects entered a 2-week, single-blind placebo run-in period and were randomized 111 to receive 7.5âmg D-ER, 10âmg 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, 7.5âmg D-ER, and 10âmg D-ER, respectively). The proportion of subjects who showed ≥20% improvement on 2âMinWT at week 12 was 13.5%, 14.0%, and 19.0%, for placebo, 7.5âmg D-ER, and 10âmg 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 2âMinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment. (Clinical Trial # NCT02271217).Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
4-Aminopyridine
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Brain Ischemia
/
Walking
/
Ischemic Stroke
Type of study:
Clinical_trials
Limits:
Adult
/
Humans
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Male
/
Middle aged
Language:
En
Journal:
Restor Neurol Neurosci
Journal subject:
NEUROLOGIA
Year:
2020
Document type:
Article
Affiliation country:
United States