Overview

Safety, Pharmacokinetics, and Exploratory Efficacy Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) Compared With Standard of Care Antiepileptic Therapy, in Patients Age 1 Month to <12 Months of Age With Tuberous Sclerosis Complex Who

Status:
Recruiting

Trial end date:
2023-04-01

Target enrollment:

Participant gender:

Summary

This study will be conducted to evaluate the safety, tolerability, and pharmacokinetics of GWP42003-P compared with standard of care (SOC) antiepileptic drug (AED) assessed during the 17-week treatment period.

Phase:

Phase 3

Details

Lead Sponsor:

GW Research Ltd

Treatments:

Cannabidiol
Epidiolex