drugset
drugset / Trial / NCT03421496

A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms

NCT03421496 ↗

Phase 3 Terminated 2 enrolled Radius Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary purpose of this study was to evaluate the efficacy, safety, and tolerability of Cannabidiol Oral Solution (CBD) as adjunctive therapy with vigabatrin as initial therapy, compared to vigabatrin alone in the treatment of infants newly diagnosed with Infantile Spasms (IS).

Timeline

Start
2018-09-05
Primary completion
2019-05-29
Completion
2019-05-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 40 mg/kg Oral
Background Vigabatrin Small molecule 150 mg/kg —

Indications

infantile spasms