A Randomized, Multi-center, Prospective, Double-blind, Phase 3 Trial of CIRARA (Glyburide for Injection) in Subjects With a Large Hemispheric Infarction

Trial Profile

A Randomized, Multi-center, Prospective, Double-blind, Phase 3 Trial of CIRARA (Glyburide for Injection) in Subjects With a Large Hemispheric Infarction

Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Aug 2016

At a glance

  • Drugs Glibenclamide (Primary)
  • Indications Cerebral infarction; Stroke
  • Focus Registrational; Therapeutic Use
  • Acronyms CHARM
  • Sponsors Remedy Pharmaceuticals
  • Most Recent Events

    • 23 Jun 2016 Planned initiation date changed from 31 Dec 2016 to 1 Apr 2017.
    • 20 Jun 2016 Status changed from planning to not yet recruiting.
    • 08 Jun 2016 According to Remedy Pharmaceuticals media release, the company has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug, CIRARA, for the treatment of Large Hemispheric Infarctions (LHI) and trial will be initiated by the end of this year.
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