Overview

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