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GWP42003-P for Autism Spectrum Disorder
This trial will test if GWP42003-P can help reduce symptoms in children with ASD.
- Autism Spectrum Disorder
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2016 Phase 3 trial • 225 Patients • NCT02224560
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Who is running the clinical trial?
- 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 score of 15 or more on the ABC-I irritability subscale.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 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 have a history of attempting suicide or have had strong thoughts of wanting to harm yourself recently.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).
- Group 1: GWP42003-P 10 mg/kg/day
- Group 2: Placebo
- 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
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."
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."
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."
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."
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."
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, 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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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