drugset / Trial / NCT02953548

Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)

NCT02953548

Phase 3 Completed 9 enrolled Jazz Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The pilot phase only will be described in this record. 2 cohorts of 5 participants will be enrolled sequentially. All participants will receive GWP42003-P.

Timeline

Start
2017-04-24
Primary completion
2018-05-07
Completion
2018-05-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 40 mg/kg Oral

Indications