A multi-centre, double blind, placebo controlled study of Stiripentol in children with Dravet syndrome
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 France
- Sponsors Biocodex
- 10 Sep 2018 New trial record
- 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.
- 23 Aug 2018 Results published in a Biocodex media release.