Phase 2
N=83
A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01605825 ↗Enrolled (actual)
83
Serious AEs
2.5%
Results posted
Mar 2014
Primary outcome: Primary: Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) — 30; 42; 16; 24 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- placebo/dalfampridine-ER (Drug); dalfampridine-ER/placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Acorda Therapeutics
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) |
30; 42; 16; 24; 16; 29 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01605825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.