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NCT04517799 · ClinicalTrials.gov registry record · Phase 2
Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism
A Phase 2 study of Autism Spectrum Disorder and Autism, sponsored by University of California, San Diego.
- Active
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT04517799: Active Phase 2 study of Autism Spectrum Disorder and Autism, sponsored by University of California, San Diego.
NCT04517799 is a Phase 2 study of Autism Spectrum Disorder and Autism that is active but no longer recruiting, run by University of California, San Diego. The registered enrollment target is 42 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04517799, a Phase 2 study of Autism Spectrum Disorder and Autism, is active but no longer recruiting, sponsored by University of California, San Diego.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
There are very few treatments that are effective in reducing severe behavioral problems associated with autism. These behaviors include aggressive and self-harm behaviors, frequent repetitive behaviors and severe hyperactivity. This study is being conducted to determine whether cannabidiol can reduce any or all of these problem behaviors.
Primary Outcome
This scale aims to capture the frequency and severity of the repetitive and restricted behaviors that are a common feature in individuals with autism spectrum disorders. The RBS-R has been validated and has been shown to have high internal consistency and inter-rater reliability when used in outpatient settings. There are 5 subscales: Stereotypic Behavior, Self-Injurious Behavior, Compulsive Behavior, Ritualistic/Sameness Behavior, and Restricted Interests. This scale will be administered to the
Conditions Studied
Interventions
- DRUG Epidiolex
- DRUG placebo oral solution
Study Locations (1)
California
- University of California San Diego - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04517799 still lists
NCT04517799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (69% lower).
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Epidiolex is the first listed.
NCT04517799 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04517799 about?
NCT04517799 is a clinical study titled "Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism". There are very few treatments that are effective in reducing severe behavioral problems associated with autism. These behaviors include aggressive and self-harm behaviors, frequent repetitive behaviors and severe hyperactivity. This study is being conducted to determine whether cannabidiol can reduc...
What is the current status of trial NCT04517799?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2020-06-01. Estimated completion is 2025-12-31.
What conditions does trial NCT04517799 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Autism.
What interventions are being tested in trial NCT04517799?
The interventions under investigation include: Epidiolex (DRUG), placebo oral solution (DRUG).
Who is sponsoring clinical trial NCT04517799?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04517799 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04517799's enrollment target sits among peer trials
42 154th of 224 higher than 71 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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