Conditions: Post-ischemic Stroke
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 294
Healthy volunteers: no

Brief summary:
This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER.

Detailed description:
This is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-ER twice daily tablets when administered for at least 12 months to subjects with chronic post-ischemic stroke walking deficits who have completed the controlled, double-blind Study DALF-PS-1016.

Arms:
arm 1: Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart.

Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. arm 2: Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart.

Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.

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

Protocol document: