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 sm) "MILESTONEā„ "

Completed

Phase 3 Results

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
  • Dalfampridine-ER 7.5mg Drug
    ARM 1: Kind: Experimental
    Label: dalfampridine-ER 7.5 mg
    Description: Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
  • Dalfampridine-ER 10mg Drug
    Other Names: Ampyra
    ARM 1: Kind: Experimental
    Label: dalfampridine-ER 10mg
    Description: Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of subjects who show at least a 20% improvement on the Two Minute Walk Test (2MinWT) at week 12 Week 12 No
Secondary Change from baseline on the Walking Impact Scale (Walk-12) at week 12 (key secondary) Baseline, week 12 No
Secondary Proportion of subjects who show at least a 20% improvement on the 2MinWT Baseline, weeks 2,4,8, double-blind average and the follow-up visits at weeks 14 and 16 No
Secondary Change from baseline on the 2MinWT Baseline, weeks 2,4,8,12, double-blind average and the follow-up visits at weeks 14 and 16 No
Secondary Change from baseline on the Walk-12 Baseline, weeks 2,4,8, double-blind average and the follow-up visits at weeks 14 and 16 No
Secondary Change from baseline on the 10 Meter Walk Test (10MWT) Baseline, weeks 2,4,8,12, double-blind average and the follow-up visits at weeks 14 and 16 No
Secondary Change from baseline on the Timed Up and Go Test (TUG) Baseline, weeks 2,4,8,12, double-blind average and the follow-up visits at weeks 14 and 16 No
Secondary Change from baseline on the Stroke Impact Scale (SIS) Baseline, weeks 2,4,8,12, double-blind average and the follow-up visits at weeks 14 and 16 No
Secondary Change from baseline on the 12-item Health Survey (SF-12) Baseline, week 12 No
Secondary Shift in projected community ambulation based on the 10MWT Baseline, week 12 No
Secondary Number of participants with Serious and Non-Serious Adverse Events (AEs) Up to 20 weeks Yes

Sponsors