Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets for Treatment of Stable Walking Deficits in Post-Ischemic Stroke (MILESTONE)
The purpose of the study is to see if taking dalfampridine-ER (Amprya®) tablets twice daily is safe and has an effect on walking abilities in people who have had a stroke.
More information on this study, "A Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets for Treatment of Stable Walking Deficits in Post-Ischemic Stroke (MILESTONE)," can be found here.
Inclusion criteria include men or women aged 18 years or older who experienced an ischemic stroke 6 months or longer prior to enrollment, clinical evidence of a stable walking deficit due to an ischemic stroke, as judged by the Investigator, based on review of medical records and physical exam, Modified Rankin Scale score of 1- 3, sufficient ambulatory ability to independently complete the 2MinWT and the 10MWT at screening, and Body Mass Index between 18-35 kg/m2 inclusive.
Key exclusion criteria include previous use of dalfampridine, fampridine or 4-aminopyridine (4-AP), a history of seizures, except simple febrile seizures, moderate to severe renal impairment, severe depression as determined by the Beck Depression Inventory (BDI) score ≥30, diagnosis of multiple sclerosis or a medical or neurological disorder that would interfere with the assessments during the study.