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A multi-centre, double blind, placebo controlled study of Stiripentol in children with Dravet syndrome

Trial Profile

A multi-centre, double blind, placebo controlled study of Stiripentol in children with Dravet syndrome

Discontinued
Phase of Trial: Phase III

Latest Information Update: 10 Sep 2018

At a glance

  • Drugs Stiripentol (Primary) ; Clobazam; Valproate
  • Indications Dravet syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms STICLO Italy
  • Sponsors Biocodex
  • Most Recent Events

    • 10 Sep 2018 New trial record
    • 23 Aug 2018 Results published in a Biocodex media release.
    • 23 Aug 2018 According to a Biocodex media release, on August 20th, 2018, the Food and Drug Administration (FDA) has approved DIACOMIT (stiripentol) for the treatment of seizures associated with Dravet syndrome (DS) in patients 2 years of age and older taking clobazam. The approval is based on STICLO France and STICLO Italy studies.
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