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

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

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated due to slow enrollment and failure to identify adequate patients that met entry criteria.”

Drugs

Indications