A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets.
Condition: Post-Ischemic Stroke
MeSH terms: Ischemic Stroke
Intervention: Placebo; dalfampridine-ER 7.5mg; dalfampridine-ER 10mg
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 377.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post stroke; Ischemic stroke

Summary:

      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.
    

Eligibility criteria:

        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