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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical Global Impressions - Improvement Scale (CGI-S) ≥ 4 (moderately ill) at screening and randomization
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 106
Awards & highlights
Study Summary
This trial will test if GWP42003-P can help reduce symptoms in children with ASD.
Who is the study for?
This trial is for children and adolescents with Autism Spectrum Disorder (ASD) who are moderately ill, weigh at least 12 kg, have an IQ of 70 or higher, and stable ASD-related treatments. They must be able to swallow liquid medication and not have other dominating conditions like ADHD or a history of substance abuse. Participants cannot be taking certain medications like clobazam or more than two anti-epileptic drugs.Check my eligibility
What is being tested?
The study tests the effectiveness of Cannabidiol Oral Solution (GWP42003-P; CBD-OS) versus a placebo in reducing symptoms of ASD in children. It's designed to see if this treatment can help manage the condition better compared to not receiving the active drug.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential side effects may include reactions related to cannabidiol such as changes in appetite, mood alterations, drowsiness, digestive issues, and possible allergic reactions due to any excipients present in the solution.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have been assessed as moderately ill on a scale called the Clinical Global Impressions - Improvement Scale (CGI-S).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 106
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 106
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Aberrant Behavior Checklist (ABC) Subscale Scores
Change from Baseline in Clinical Global Impression Severity (CGI-S) Scores
Change from Baseline in Vineland Adaptive Behavior Scales-3 (VABS-3) Scores
+1 moreSecondary outcome measures
Number of Participants with Clinically Significant 12-lead Electrocardiogram Findings
Number of Participants with Clinically Significant Clinical Laboratory Parameter Values
Number of Participants with Clinically Significant Physical Examination Procedure Findings
+3 moreSide effects data
From 2016 Phase 3 trial • 225 Patients • NCT0222456021%
Somnolence
16%
Upper respiratory tract infection
16%
Decreased appetite
10%
Status epilepticus
10%
Diarrhoea
9%
Pyrexia
9%
Irritability
7%
Fatigue
6%
Insomnia
6%
Vomiting
4%
Pneumonia
4%
Lethargy
4%
Nasopharyngitis
3%
Headache
3%
Convulsion
1%
Cholecystitis chronic
1%
Hypoventilation
1%
Dehydration
1%
Pancreatitis
1%
Sleep apnoea syndrome
1%
Aspartate aminotransferase increased
1%
Sedation
1%
Transaminases increased
1%
Pneumonia bacterial
1%
Pneumonia respiratory syncytial viral
1%
Hypoxia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo-Safety Analysis Set
GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set
GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: GWP42003-P 10 mg/kg/dayExperimental Treatment1 Intervention
Participants will be stratified based on their age (6 to 11 years old, 12 to 17 years old), use of antipsychotics (on versus off), and region (North America versus Rest of the World) and will be randomized to receive 5 milligrams per kilogram per day (mg/kg/day) GWP42003-P for 1 week and then 10 mg/kg/day GWP42003-P for 11 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be stratified based on their age (6 to 11 years old, 12 to 17 years old), use of antipsychotics (on versus off), and region (North America versus Rest of the World) and will be randomized to receive matching placebo for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GWP42003-P
2016
Completed Phase 3
~1740
Find a Location
Who is running the clinical trial?
GW Research LtdLead Sponsor
34 Previous Clinical Trials
3,100 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
1 Patients Enrolled for Autism Spectrum Disorder
Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,251 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
102 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are moderately ill according to a standard rating scale used in the study.You are at least 12 kilograms (kg) in weight.You have a diagnosis other than Autism Spectrum Disorder (ASD) that is more prominent, like Attention Deficit Hyperactivity Disorder (ADHD).You are currently taking more than two medications for epilepsy.You are currently taking clobazam.You have a known or suspected allergy to cannabinoids or any of the ingredients in the medication, like sesame oil.You have a history of attempting suicide or have had strong thoughts of wanting to harm yourself recently.You have a score of 15 or more on the ABC-I irritability subscale.You had brain surgery or a serious head injury within the past year.You are willing and able to give informed assent and consent for participation in the trial.You are willing and able (in the investigator's opinion) to comply with all trial requirements.You are currently taking sirolimus, everolimus, temsirolimus, or tacrolimus medications.You are currently taking certain medications like repaglinide, pioglitazone, rosiglitazone, montelukast, bupropion, or efavirenz.You currently have bipolar disorder, psychosis, schizophrenia, schizoaffective disorder, or major depression that is not in remission.You have a worsening neurological condition.You have had seizures within the last 24 weeks.You are currently taking omeprazole, lansoprazole, tolbutamide, or warfarin.You have another serious illness or condition that could make it risky for you to participate in the trial, could affect the trial's results, or could make it difficult for you to take part.You have been assessed as moderately ill on a scale called the Clinical Global Impressions - Improvement Scale (CGI-S).
Research Study Groups:
This trial has the following groups:- Group 1: GWP42003-P 10 mg/kg/day
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current vacancies in this research project for participants?
"From what is detailed on clinicaltrials.gov, it appears that this particular clinical trial is still recruiting patients. The initial posting was on 5/31/2021 with the most recent update being 11/7/2022."
Answered by AI
Has GWP42003-P undergone FDA drug approval process yet?
"Even though there is no data yet supporting GWP42003-P's efficacy, it received a score of 2 because there are reports confirming its safety."
Answered by AI
Could you tell me if the age limit for participants is older than 60 years old in this trial?
"According to the inclusion criteria, this trial is only open to applicants aged 6-17. Out of the clinical trials that exist, 254 are for people under 18 and 97 are for those over 65."
Answered by AI
Could you please outline the previous research surrounding GWP42003-P?
"There are currently 83 active clinical trials researching GWP42003-P, with 18 of them in Phase 3. Several of the studies for GWP42003-P are running out of Ribeirao Preto, Sao Paulo, but there are 311 locations operating trials for it in total."
Answered by AI
Does this study have any restrictions on who can join?
"The ideal candidates for this autism spectrum disorder study are children aged 6 to 17. There is a goal to recruit 160 patients in total."
Answered by AI
How many trial sites are there in total?
"The research team conducting this study is based out of Richmond Behavioral Associates in Staten Island, New york, Massachusetts General Hospital (Lurie Center for Autism) in Lexington, Massachusetts, and Center for Pediatric Excellence in Ottawa, Ontario. There are also 14 other sites where this study is being conducted."
Answered by AI
Who else is applying?
What state do they live in?
New York
Arizona
California
How old are they?
< 18
What site did they apply to?
Clinical Trial Site
University of California San Francisco
Richmond Behavioral Associates
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
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