A confirmatory phase III trial of Firdapse in patients with Lambert-Eaton myasthenic syndrome

Trial Profile

A confirmatory phase III trial of Firdapse in patients with Lambert-Eaton myasthenic syndrome

Planning
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2016

At a glance

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

    • 09 Aug 2016 According to a Catalyst Pharmaceuticals media release, company expects to start this trial in the fourth quarter 2016 and anticipates having two clinical trial sites, one each on the east and west coasts of the U.S.The company will enroll subjects from the company's Expanded Access Programme.
    • 09 Aug 2016 According to a Catalyst Pharmaceuticals media release, company has reached an agreement with the FDA during the quarter on this trial protocol. Company anticipates filling an NDA resubmission based on the top-line data in the second half of 2017.
    • 13 Jun 2016 According to a Catalyst Pharmaceuticals media release, firdapse for the treatment of LEMS has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and orphan drug designation for LEMS and CMS.
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