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Oral cannabidiol 100mg/mL for Autism

Children's Hospital Colorado, Aurora, CO
Autism+6 More ConditionsOral cannabidiol 100mg/mL - Drug
Eligibility
5 - 17
All Sexes

Study 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
  • Autism Spectrum Disorder (ASD)
  • Autism Spectrum Disorder with Neuropsychiatric Symptoms (ASD-NPS)
  • Autism Spectrum Disorder

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

1 Primary · 23 Secondary · Reporting Duration: Baseline to Week 12

Baseline to Week 12
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): Irritability subscale raw score
Aberrant Behavior Checklist- 2nd Edition (ABC-2): Lethargy/Social Withdrawal subscale
Aberrant Behavior Checklist- 2nd Edition (ABC-2): Stereotypic Behavior subscale
Anxiety, Depression, and Mood Scale (ADAMS): General Anxiety subscale
Anxiety, Depression, and Mood Scale (ADAMS): Social Avoidance subscale
Anxiety, Depression, and Mood Scale (ADAMS): Total Score
Autism Family Experience Questionnaire (AFEQ)
Autism Screening Instrument for Educational Planning - 3rd Edition (ASIEP - 3): Interaction Assessment Autism Interaction Score
Autism Screening Instrument for Educational Planning- 3rd Edition Sample of Vocal Behavior (ASIEP-3 SVB) Vocalization Score
AutismEyes Eyetracking system Autism Symptoms Index (ASI)
Brief Rating Inventory of Executive Functioning - 2nd edition (BRIEF-2): ADHD score
Brief Rating Inventory of Executive Functioning - 2nd edition (BRIEF-2): Global Executive Functioning Score
Brief Rating Inventory of Executive Functioning - 2nd edition (BRIEF-2): Index scores
NIH Toolbox Scales: Life Satisfaction - Short Form 8b
NIH Toolbox Scales: Positive Affect - Short Form 4a
NIH Toolbox Scales: Satisfaction with Social Roles and Activities - Short Form 4a
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) scale
Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) scale
Parent/Caregiver Improvement Scale
Pediatric Quality of Life Inventory (PedsQL) - Cognitive Functioning Scale
Pediatric Quality of Life Inventory (PedsQL) - Core Scale
Repetitive Behavior Scale - Revised (RBS-R)
Sleep Clinical Global Impressions - Improvement Scale (Sleep CGI-I)
Sleep Clinical Global Impressions - Severity Scale (Sleep CGI-S)
Social Responsiveness Scale - 2nd Edition (SRS-2): total T-score
Telehealth Functional Behavior Analysis (Tele-FBA)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Cannabidiol
1
Confirmatory Dosing - PRAX-222
2
INP105

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

3 Treatment Groups

Arm 3: 15 weeks of placebo then 12 weeks of study drug
1 of 3
Arm 3: 27 weeks of study drug
1 of 3
Arm 1: 12 weeks of study drug then 15 weeks of placebo
1 of 3

Experimental Treatment

70 Total Participants · 3 Treatment Groups

Primary Treatment: Oral cannabidiol 100mg/mL · Has Placebo Group · Phase 2

Arm 3: 15 weeks of placebo then 12 weeks of study drugExperimental Group · 2 Interventions: Oral cannabidiol 100mg/mL, Placebo · Intervention Types: Drug, Drug
Arm 3: 27 weeks of study drug
Drug
Experimental Group · 1 Intervention: Oral cannabidiol 100mg/mL · Intervention Types: Drug
Arm 1: 12 weeks of study drug then 15 weeks of placeboExperimental Group · 2 Interventions: Oral cannabidiol 100mg/mL, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 12

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,644 Previous Clinical Trials
1,660,971 Total Patients Enrolled

Eligibility Criteria

Age 5 - 17 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients must either be receiving treatment with one to two antiepileptic drugs, or have been seizure-free for the last 12 months if not taking any medication.
You have been determined to be significantly affected by ASD by the Investigator.

Who else is applying?

What state do they live in?
Ontario50.0%
Virginia50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Children's Hospital Colorado100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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