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: 29 Nov 2017

At a glance

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

    • 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.
    • 27 Nov 2017 According to a Catalyst Pharmaceutical media release, the company is planning to present further data in future publications and at medical conferences
    • 27 Nov 2017 Primary endpoint has been met. (Subject Global Impression (SGI) score), according to a Catalyst Pharmaceutical media release.
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