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


Phase 2 Results

Eligibility 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