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Cannabinoid
Oral cannabidiol 100mg/mL for Autism Spectrum Disorder (CASCADE Trial)
Phase 2
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights
CASCADE Trial Summary
This trial will test the effects of CBD on children with autism. All participants will receive CBD at some point, for 12 weeks or more.
Eligible Conditions
- Autism Spectrum Disorder
- Autism
CASCADE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Aberrant Behavior Checklist- 2nd Edition (ABC-2): Irritability subscale raw score
Secondary outcome measures
Aberrant Behavior Checklist- 2nd Edition (ABC-2): Hyperactivity/Noncompliance subscale
Aberrant Behavior Checklist- 2nd Edition (ABC-2): Inappropriate Speech subscale
Aberrant Behavior Checklist- 2nd Edition (ABC-2): Lethargy/Social Withdrawal subscale
+20 moreOther outcome measures
Autism Screening Instrument for Educational Planning- 3rd Edition Sample of Vocal Behavior (ASIEP-3 SVB) Vocalization Score
AutismEyes Eyetracking system Autism Symptoms Index (ASI)
Parent/Caregiver Improvement Scale
+1 moreCASCADE Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm 3: 27 weeks of study drugExperimental Treatment1 Intervention
Subjects in this group will receive cannabidiol throughout the entire 27 weeks of treatment.
Group II: Arm 3: 15 weeks of placebo then 12 weeks of study drugExperimental Treatment2 Interventions
Subjects in this group will receive placebo for the first 15 weeks of the study and cannabidiol for the last 12 weeks.
Group III: Arm 1: 12 weeks of study drug then 15 weeks of placeboExperimental Treatment2 Interventions
Subjects in this group will receive cannabidiol for the first 12 weeks of the study and placebo for the last 15 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,478 Total Patients Enrolled
12 Trials studying Autism Spectrum Disorder
1,766 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Parents/caregivers need to be able to read and answer questions and forms in English.You have a suspected or confirmed heart or blood vessel problem.If you take medication for mental health, you need to have been on the same medication for at least 4 weeks before the study starts, and you can't change it during the study.If you are getting non-medication treatments or therapies, they must be stable for at least 2 months before the screening. Changes during school breaks are okay.The doctor has to confirm that you are significantly affected by ASD.If you have seizures, you must have been taking the same anti-seizure medication for at least 3 months before joining the study, and you can only take up to 2 different seizure medications. You must keep taking the same dose of your seizure medication during the study.Kids and teens between 5 and 17 years old can participate.A parent or caregiver must give written permission to help with giving the study drug.You have a history of serious allergies or bad reactions to CBD (Epidiolex) or its ingredients.You are currently taking clobazam, felbamate, vigabatrin, or everolimus.You have severe or unstable symptoms of Autism Spectrum Disorder (ASD) that may make it difficult to evaluate the study results accurately.The doctor thinks you are healthy based on your medical history, physical exam, ECG, and lab tests.The doctor thinks you and your caregivers will do everything the study requires, like going to appointments and following the rules.If you have a history of seizures, you must be taking a consistent treatment with one or two anti-seizure medications, or you must have been seizure-free for a year without medication.If you take medicine for your mood or behavior, you should have been on the same medicines for at least 4 weeks before the study starts, and you need to keep taking the same medicines during the study.If you are getting educational, behavioral, or dietary treatments that aren't medicine, you need to have been doing them the same way for at least 2 months before the screening, except for during school breaks.Kids and teenagers between 5 and 17 years old can take part in the study.Your body mass index (BMI) must be between 12 and 32 kg/m2.You have been diagnosed with ASD by a doctor or psychologist.If you have seizures, you should have been taking the same two seizure medicines for at least three months before joining the study, and you need to keep taking the same dose during the study.If you are a woman who could become pregnant, you must have a negative pregnancy test before starting the study and at certain times during the study.You and your caregiver agree to follow all the rules and instructions for the study.Patients and their caregivers must understand the study and its risks and agree in writing before being checked for eligibility.You must have been diagnosed with ASD by a doctor or psychologist.If you have a history of seizures, you must be taking a consistent treatment for it, or have been seizure-free for at least a year.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: 12 weeks of study drug then 15 weeks of placebo
- Group 2: Arm 3: 15 weeks of placebo then 12 weeks of study drug
- Group 3: Arm 3: 27 weeks of study drug
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.
Does this investigation accept individuals younger than fifty years of age?
"In order to be suitable for this clinical trial, participants must fall between the age range of 5 and 17 years old."
Answered by AI
Is recruitment for this clinical experiment currently in process?
"Clinicaltrials.gov reveals that this study is actively enrolling participants as of now, with the first posting date being December 15th 2021 and last edit occurring on January 6th 2022."
Answered by AI
What is the sample size of participants engaged in this experiment?
"Affirmative, the clinicaltrials.gov database states that sign-ups are open for this experiment which was first published on December 15th 2021 and revised lastly on January 6th 2022. Seventy volunteers need to be recruited from one medical center."
Answered by AI
Is there any risk associated with consuming Oral cannabidiol 100mg/mL?
"The safety of Oral cannabidiol 100mg/mL was rated a 2 on our team's scale due to the presence of some data supporting its safety, yet no evidence of efficacy."
Answered by AI
Are there any past test cases for Oral cannabidiol 100mg/mL?
"At present, 79 clinical trials are underway for Oral cannabidiol 100mg/mL with 16 of them in their third phase. While Ribeirao Preto is an epicentre for this study, there are participating locations across 290 sites worldwide."
Answered by AI
Am I qualified to enroll in this experiment?
"This research endeavour is seeking to enrol 70 individuals with Autism Spectrum Disorder in the age range of 5-17 years. Furthermore, potential participants must meet certain criteria such as possessing a BMI between 12-32 kg/m2 (inclusive) and being on a stable regimen for psychotropic medication(s). Additionally, those receiving non-pharmacological educational, behavioural and dietary interventions must have been doing so for two months prior to screening. Lastly, patients with seizure disorders should either be currently taking one or two anti-epileptic drugs (AEDs), or they must remain seizure free over the course of one year."
Answered by AI
Who else is applying?
What state do they live in?
Ontario
Virginia
How old are they?
18 - 65
What site did they apply to?
Children's Hospital Colorado
What portion of applicants met pre-screening criteria?
Did not meet criteria
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