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Cannabidiol for Autism
Study Summary
This trial is testing whether cannabidiol can help reduce severe behavioral problems in people with autism.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 1 & 2 trial • 3 Patients • NCT04238754Trial Design
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Who is running the clinical trial?
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- You often hurt yourself or others on a regular basis, almost every day.Children who are allergic to any ingredients in the study drug.You have epilepsy.You have serious heart problems, a known brain birth defect, or a history of infection in your brain or spinal cord.You frequently show aggressive or self-injurious behaviors almost every day in different places like home, school, or clinic.Boys between 7 and 14 years old.The seriousness of symptoms will be determined using certain standards.The activities listed above make it difficult for the child to function, according to what the parent and doctor have observed or discussed.You have been diagnosed with autism using ADOS testing.You often do the same actions over and over again, like hand flapping or running in circles, every day for at least 5-10 minutes at a time.The child is extremely active and has trouble sitting still for meals or school work, and is always moving around, jumping off furniture, or climbing onto furniture.Your autism is very severe and comes with significant behavior issues.
- Group 1: cannabidiol
- 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 other examples of CBD-based medication?
"As of now, 83 clinical trials regarding Epidiolex are ongoing with 18 of them being Phase 3 trials. Many of these trials are based in Ribeirao Preto, Sao Paulo, but there are 311 total locations for these Epidiolex studies."
Could you expand on the age requirement for this clinical trial?
"Among the 311 medical trials for patients under 18 and 157 for patients over 65, this study is unique in that it only includes patients that fall between the ages of 7-14."
What are the medical prerequisites for participating in this research project?
"This trial is seeking 42 participants between the ages of 7 and 14 who have autism spectrum disorder. In addition to meeting this criteria, potential patients must also exhibit the following behaviors: aggressive and/or self-injurious behaviors occurring almost daily, frequent and persistent stereotypies, pervasive hyperactivity, and/or difficulty functioning in daily life as reported by parents and confirmed by clinicians."
Are we able to sign new patients up for this clinical trial?
"No, this specific trial is not actively recruiting, however, there are 477 other trials that are. This particular study was posted on clinicaltrials.gov on 6/1/2020 and was last updated on 3/16/2022."
How many total people are eligible for this research?
"Presently, this clinical trial is not looking for new participants. According to the posting on clinicaltrials.gov, the study was originally shared on June 1st, 2020 with the most recent update on March 16th, 2022. There are presently 394 other studies actively enrolling participants with autism and 83 for Epidiolex."
Who else is applying?
How old are they?
What portion of applicants met pre-screening criteria?
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