drugset / Trial / NCT02564952

An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol

NCT02564952

Phase 2 Completed 18 enrolled Jazz Pharmaceuticals
NaSingle-groupOpen-labelOther

Summary

This study consisted of 2 parts: a double-blind (DB) phase and an open-label extension (OLE) phase. Only the OLE phase is described in this record. The OLE phase was a safety study. All participants received GWP42003-P initially titrated to 20 milligrams (mg)/kilograms (kg)/day; however, investigators subsequently decreased or increased the participant's dose to a maximum of 30 mg/kg/day (no minimum).

Timeline

Start
2016-03-11
Primary completion
2017-06-07
Completion
2017-06-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 20 mg/kg Oral
Background Clobazam Small molecule

Indications