Overview

A Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms

Status:
Terminated

Trial end date:
2019-05-29

Target enrollment:

Participant gender:

Summary

The primary objective of this study is to evaluate the efficacy of Cannabidiol Oral Solution as adjunctive therapy with vigabatrin as initial therapy in treating participants with Infantile Spasms. The secondary objectives for this study are to evaluate the continued efficacy of Cannabidiol Oral Solution after the 14-day treatment with vigabatrin or vigabatrin plus Cannabidiol Oral Solution is complete and to evaluate the safety and tolerability of Cannabidiol Oral Solution as adjunctive therapy with vigabatrin as initial therapy in treating participants with infantile spasms.

Phase:

Phase 3

Details

Lead Sponsor:

Benuvia Therapeutics Inc.
INSYS Therapeutics Inc

Treatments:

Cannabidiol
Pharmaceutical Solutions
Vigabatrin