Trial Profile

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

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 10 Sep 2018

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At a glance

Drugs Stiripentol (Primary) ; Clobazam; Valproate
Indications Dravet syndrome
Focus Registrational; Therapeutic Use
Acronyms STICLO France
Sponsors Biocodex

Most Recent Events

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.

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