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A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of MAP0004 in Adult Migraineurs for a Single Migraine Followed by Open Label Extension.

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Trial Profile

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of MAP0004 in Adult Migraineurs for a Single Migraine Followed by Open Label Extension.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 May 2015

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At a glance

  • Drugs Dihydroergotamine mesilate (Primary)
  • Indications Migraine
  • Focus Registrational; Therapeutic Use
  • Acronyms FREEDOM-301
  • Sponsors MAP Pharmaceuticals

Most Recent Events

  • 02 Aug 2011 Results from the primary part of the trial and the long-term safety extension were used as the basis of a NDA, which has been submitted to the US FDA.
  • 07 Apr 2011 Full results of the study were published in the journal Headache, according to a MAP Pharmaceuticals media release.
  • 01 Apr 2011 Results published in the Headache.

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