A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acorda Therapeutics
• Treatments: 4-Aminopyridine

Criteria

Inclusion Criteria:

• History of a stable sensorimotor deficit due to an ischemic stroke, as confirmed by the Investigator with supportive prior imaging findings (MRI/ CT scan)

• ≥ 6 months post-stroke

• Have a body mass index (BMI) ranging between 18.0 - 35.0 kg/m,2 inclusive

• Stable concomitant medication therapy regimen within 4 weeks of screening visit

Exclusion Criteria:

• History of seizures, except simple febrile seizures

• Moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute using the Cockcroft-Gault Equation

• Botulinum toxin use within 2 months prior to the Screening Visit

• Orthopedic surgical procedures in any of the extremities within the past 6 months

• Diagnosis of multiple sclerosis