Article

OBJECTIVE: To evaluate the safety and tolerability of dalfampridine extended
release (D-ER) in participants with chronic post-ischemic stroke deficits, and to
assess for potential drug activity on sensorimotor function. METHODS: Using a
double-blind, placebo-controlled, cross-over design, participants were randomized
to placebo/D-ER or D-ER/placebo sequences and given D-ER 10 mg or placebo twice
daily. Key inclusion criteria were: ischemic stroke >/= 6 months, Fugl-Meyer
Assessment lower extremity motor score </= 28, ability to complete Timed 25-Foot
Walk (T25FW). The primary outcome was safety and tolerability. The key
exploratory measure was walking speed (T25FW). Other assessments were: Box and
Block, and Grip and Pinch tests; Functional Independence Measure. Full-crossover
data were analyzed using mixed-effects model. RESULTS: A total of 83 participants
were randomized: 70 completed and 13 discontinued the study. Adverse events were
consistent with previous D-ER trials; no new safety signals were observed. Four
participants experienced serious adverse events: 3 seizures (1 placebo, 2 D-ER),
1 was secondary to intentional overdose. Most common treatment-emergent adverse
events were: dizziness, nausea, arthralgia and fatigue. Mixed-effects analysis
showed an effect for D-ER vs. placebo in improving walking speed (0.21 vs. 0.10
ft/s; p = 0.027). CONCLUSIONS: D-ER was generally well tolerated in participants
with chronic stroke deficits. Potential drug activity on lower extremity
sensorimotor function, with an improvement in walking speed, was seen.

Langue : ANGLAIS