Clinical Trial: A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3, Double-blind, Placebo-controlled, Randomized Discontinuation Study Followed by Open-label Extension Evaluating Efficacy and Safety of Amifampridine Phosphate in Patients With

  • Change from Baseline Quantitative Myasthenia Gravis (QMG)at 14 days [ Time Frame: Assessment at Baseline, Day 8, and Day 14 ]
  • Change in SGI score [ Time Frame: Assessment at Baseline, Days 8 & 14 ]
    Subject Global Impression (SGI) is a measure of changes in subject's perception of change in overall wellbeing


    • Original Primary Outcome: Change from Baseline Quantitative Myasthenia Gravis (QMG)at 14 days [ Time Frame: Assessment at Baseline, Day 8, and Day 14 ]

    Current Secondary Outcome:

    • Change from Baseline Timed 25 Foot Walking Test (T25FW)at 14 days [ Time Frame: Assessment at Baseline, Day 8, and Day 14 ]
    • Change in CGI-I score [ Time Frame: Baseline, Days 8 & 14 ]
      Investigator perceived global improvement or change


    Original Secondary Outcome: Change from Baseline Timed 25 Foot Walking Test (T25FW)at 14 days [ Time Frame: Assessment at Baseline, Day 8, and Day 14 ]

    Information By: Catalyst Pharmaceuticals, Inc.

    Dates:
    Date Received: June 17, 2011
    Date Started: June 2011
    Date Completion:
    Last Updated: July 26, 2016
    Last Verified: July 2016