Conditions: Ischemic Stroke
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 83
Healthy volunteers: no

Brief summary:
This is a multi-center, safety and tolerability study in subjects with chronic stable sensorimotor deficits after ischemic stroke. It has been designed as a double-blind, placebo-controlled, 2-period crossover study.

Detailed description:

Arms:
arm 1: Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:

Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36 arm 2: Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:

Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36

Interventions: intervention 1: placebo/dalfampridine-ER intervention 2: dalfampridine-ER/placebo
Intervention descriptions: intervention 1: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart intervention 2: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart

Protocol document: