Conditions: Post-Ischemic Stroke
Keywords: Post stroke Ischemic stroke
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 377
Healthy volunteers: no

Brief summary:
The objective of this study is to determine the effect of two dose strengths of dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable walking deficits in subjects with post-ischemic stroke.

Detailed description:
This was a randomized, placebo-controlled, three-arm, parallel-group study designed to evaluate the efficacy, safety, and tolerability of dalfampridine extended release (ER) tablets on chronic walking deficits in subjects with post-ischemic stroke.

Arms:
arm 1: Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart. arm 2: Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart. arm 3: Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.

Interventions: intervention 1: Placebo intervention 2: dalfampridine-ER 7.5mg intervention 3: dalfampridine-ER 10mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: