A Multicenter, Open-label, Flexible Dose Study to Assess the Long-term Safety of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Treatment for Pediatric and Adult Subjects With a Treatment-resistant Seizure Disorder Who Complete INS011-14-029 or Part A of INS011-15-054

Trial Profile

A Multicenter, Open-label, Flexible Dose Study to Assess the Long-term Safety of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Treatment for Pediatric and Adult Subjects With a Treatment-resistant Seizure Disorder Who Complete INS011-14-029 or Part A of INS011-15-054

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 02 May 2017

At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Dravet syndrome; Lennox-Gastaut syndrome
  • Focus Adverse reactions; Registrational
  • Sponsors INSYS Therapeutics, Inc
  • Most Recent Events

    • 26 Oct 2016 Status changed from recruiting to active, no longer recruiting.
    • 24 Jun 2016 Planned number of patients changed from 232 to 54.
    • 04 Jan 2016 Planned End Date changed from 1 Sep 2017 to 1 Dec 2017, according to ClinicalTrials.gov record.
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