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A Phase 3, Double-blind, Outpatient Crossover Study to Evaluate the Efficacy and Safety of Amifampridine Phosphate (3,4 Diaminopyridine Phosphate) in Patients With Congenital Myasthenic Syndromes (CMS)

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Trial Profile

A Phase 3, Double-blind, Outpatient Crossover Study to Evaluate the Efficacy and Safety of Amifampridine Phosphate (3,4 Diaminopyridine Phosphate) in Patients With Congenital Myasthenic Syndromes (CMS)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Amifampridine (Primary)
  • Indications Congenital myasthenic syndromes
  • Focus Therapeutic Use
  • Sponsors Catalyst Pharmaceuticals

    • Most Recent Events

    • 26 Nov 2020 This trial has been completed in Italy according to European Clinical Trials Database record.
    • 12 Nov 2019 According to Catalyst Pharmaceuticals media release, the company expects to meet with the U.S. FDA before year-end to discuss CMS-001 study outcome and path forward.
    • 30 Oct 2019 Primary endpoint (Change from baseline in the subject global impression (SGI) scale) has not been met

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