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.

GW Research Ltd0 sites103 target enrollmentApril 27, 2021

ConditionsAutism Spectrum Disorder (ASD)MedDRA version: 21.1Level: PTClassification code 10063844Term: Autism spectrum disorderSystem Organ Class: 10037175 - Psychiatric disorders Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

DrugsEpidyolex

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Autism Spectrum Disorder (ASD)
Sponsor: GW Research Ltd
Enrollment: 103
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 27, 2021

End Date

December 21, 2023

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GW Research Ltd

Eligibility Criteria

Inclusion Criteria

•For inclusion in the trial, patients must fulfill ALL of the following criteria:
•Male or female aged 6 to 17 years (inclusive).
•Patient weight is at least 12 kg.
•Patients (if possessing adequate understanding, in the investigator’s opinion) and their parent(s)/legal representative are willing and able to give informed assent and consent for participation in the trial.
•Patient and their caregiver are willing and able (in the investigator’s opinion) to comply with all trial requirements.
•Patient has a diagnosis of ASD as per DSM\-5 criteria for ASD, confirmed by ADOS\-2 criteria (conducted within 2 years at the trial site or at screening by a qualified assessor). Note: During special circumstances (e.g., COVID\-19 pandemic) where the ADOS\-2 cannot be performed due to site restrictions (e.g., mandatory use of face masks) and an ADOS\-2 conducted within 2 years at the trial site by a qualified assessor is not available, eligibility can be confirmed using: 1\) an ADOS\-2 performed within 2 years by a qualified assessor(external to the site); 2\) if 1\) is not available, eligibility may be confirmed using the ADI\-R at screening.
•CGI\-S \> or \= 4 (moderately ill) at screening and randomization.
•ABC\-I subscale score \= 15 at screening.
•IQ \> or \= 70 at screening, or measured within 1 year of screening, using WASI\-II.
•All medications or interventions (including psychosocial interventions, dietary supplements, probiotics, speech therapy, etc.) for ASD related symptoms must have been stable for 4 weeks prior to screening and randomization, and the patient/caregiver should be willing to maintain a stable regimen throughout the trial.

Exclusion Criteria

•The patient may not enter the trial if ANY of the following apply:
•Current diagnosis of bipolar disorder, psychosis, schizophrenia, schizoaffective disorder, or major depression (patients with depression in remission may be included).
•Has a diagnosis other than ASD that dominates the clinical presentation (e.g., ADHD).
•Has a progressive neurological condition.
•Seizures in the past 24 weeks.
•Changes in anticonvulsive therapy within the last 12 weeks.
•Currently taking more than 2 AEDs.
•Taking sirolimus, everolimus, temsirolimus, or tacrolimus.
•Taking clobazam.
•Taking omeprazole, lansoprazole, tolbutamide, or warfarin.