drugset / Trial / NCT02318602

Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder

NCT02318602

Phase 3 Completed 52 enrolled INSYS Therapeutics Inc
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS). All participants have rolled over from previous trials: INS011-14-029 (NCT02324673) and INS011-15-054 (NCT02551731).

Timeline

Start
2016-01-08
Primary completion
2017-06-22
Completion
2017-06-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 40 mg/kg Oral

Indications