A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets.
A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets.
The objective of this study is to determine the effect of two dose strengths of
 dalfampridine-Extended Release (ER) tablets, taken twice daily for 12 weeks, on stable
 walking deficits in subjects with post-ischemic stroke.
This was a randomized, placebo-controlled, three-arm, parallel-group study designed to
 evaluate the efficacy, safety, and tolerability of dalfampridine extended release (ER)
 tablets on chronic walking deficits in subjects with post-ischemic stroke.
Inclusion Criteria:

 -  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. Such deficit
 was not present prior to the stroke and cannot be attributed primarily to other
 conditions (e.g. chronic obstructive pulmonary disease, arthritis). Evidence of
 walking deficits is objectively supported by any one of the following findings on
 clinical examination:

 1. obvious slowness of movement assigned primarily to the stroke

 2. use of an assistive walking device such as a cane or walker

 3. Presence of movement pattern deviations such as stiff-legged gait, foot drop, hip
 hiking and hip circumduction

 -  Modified Rankin Scale score of 1 - 3, regardless of the cause(s) of the disability

 -  Sufficient ambulatory ability to independently complete the 2MinWT and 10MWT

 -  ≥ 6 months from occurrence of most recent stroke

 Exclusion Criteria:

 -  Woman who is not surgically sterile or is less than 2 years postmenopausal, and does
 not agree to use a highly effective birth control method during the study and up to 3
 months after the last dose of investigational product.

 -  Woman who is pregnant, breastfeeding, or planning to become pregnant

 -  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

 -  Suicide attempt within 1 year prior to the Screening Visit, or severe suicidal
 ideation within 6 months prior to the Screening Visit, or subject is at significant
 risk of suicidal behavior in the opinion of the Investigator

 -  Previous use of AMPYRA, dalfampridine, fampridine or 4-aminopyridine (4-AP)

 -  Initiation of a serotonin reuptake inhibitor (SSRI) within 3 months prior to the
 Screening Visit, or any change in dosing regimen within 3 months prior to the
 Screening Visit

 -  Botulinum toxin use within 2 months prior to the Screening Visit

 -  Orthopedic surgical procedures in any of the extremities within the past 6 months