A Phase 3, Double-Blind, Placebo-controlled, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Amifampridine Phosphate in Patients With Lambert-Eaton Myasthenic Syndrome

Trial Profile

A Phase 3, Double-Blind, Placebo-controlled, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Amifampridine Phosphate in Patients With Lambert-Eaton Myasthenic Syndrome

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Feb 2018

At a glance

  • Drugs Amifampridine (Primary)
  • Indications Lambert-Eaton myasthenic syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors Catalyst Pharmaceutical
  • Most Recent Events

    • 12 Feb 2018 According to a Catalyst media release, the company announced the results of its recent Type C meeting with U.S. Food and Drug Administration. Prior to the meeting, Catalyst had provided the FDA with its preliminary data package for the proposed NDA resubmission, including clinical, non-clinical, regulatory and abuse liability elements.
    • 12 Feb 2018 According to a Catalyst media release, the company anticipates resubmitting its NDA for Firdapse for LEMS to the FDA by the end of the first quarter of 2018 using positive top-line results from this study as well as the recently completed FDA-required abuse liability studies demonstrating that Firdapse does not have abuse potential.
    • 27 Nov 2017 Positive Results of this trial will support planned NDA submission in the first quarter of 2018, as reported in a Catalyst Pharmaceutical media release.
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