CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 103 enrolled
Drug / intervention
GWP42003-P +1 moredrug
Likely dose
GWP42003-P 100 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04745026
NCT04745026Phase 2Completed
CompareCT.gov

An Exploratory, Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Investigate the Safety and Efficacy of Cannabidiol Oral Solution (GWP42003-P; CBD-OS) in Children and Adolescents With Autism Spectrum Disorder

Jazz Pharmaceuticals·interventional·Posted Feb 9, 2021·Updated Mar 30, 2025

In Brief

A Phase 2 clinical trial evaluating GWP42003-P and Placebo for Autism Spectrum Disorder. Completed, enrolled 103 participants across 23 sites in 6 countries.

Detailed Summary

This study will be conducted to evaluate the efficacy of GWP42003-P, compared with placebo, in reducing symptom severity in children with Autism Spectrum Disorder (ASD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism Spectrum Disorder
CountriesAustralia, Canada, Germany, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedFeb 9, 2021
Enrollment StartMay 31, 2021
Primary CompletionDec 21, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 5.4 years ago

Interventions

GWP42003-Pdrug

GWP42003-P oral solution (100 milligrams per milliliter \[mg/mL\] cannabidiol \[CBD\] in sesame oil with anhydrous ethanol, ethanol \[10% v/v\] sweetener \[sucralose\], and strawberry flavoring), administered twice a day (morning and evening)

Placebodrug

Oral placebo to match GWP42003-P oral solution containing sesame oil with anhydrous ethanol, sweetener (sucralose), strawberry flavoring, and beta carotene, administered twice a day (morning and evening)