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Cannabinoid
CBD for Autism (CASCADE Trial)
Phase 2
Waitlist Available
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
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.
Who is the study for?
This trial is for children and adolescents aged 5-17 with Autism Spectrum Disorder (ASD). They must be on a stable regimen of no more than two psychotropic or anti-epileptic drugs, if applicable, and not planning to change treatments during the study. Participants need a BMI between 12-32 kg/m2 and have been diagnosed by a professional. Females who can bear children must test negative for pregnancy.
What is being tested?
The CASCADE trial tests oral cannabidiol (CBD) against a placebo in kids with ASD. It's randomized and controlled, meaning some get CBD while others get an inactive substance without knowing which one they receive. All participants will eventually receive CBD for at least 12 weeks during the study.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with CBD may include drowsiness, changes in appetite or mood, diarrhea, fatigue, malaise, weakness or sleeping problems. Parents should monitor their children closely for any unexpected reactions.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Aberrant Behavior Checklist- 2nd Edition (ABC-2): Irritability subscale raw score
Secondary study objectives
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 study objectives
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 moreTrial 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
1,802 Previous Clinical Trials
2,822,026 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.
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