A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Neurology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 4/21/2016 |
Start Date: | May 2012 |
End Date: | March 2013 |
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.
sensorimotor deficits after ischemic stroke. It has been designed as a double-blind,
placebo-controlled, 2-period crossover study.
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
We found this trial at
20
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials