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NCT03900923 · ClinicalTrials.gov registry record · Phase 2
Cannabidiol for ASD Open Trial
A Phase 2 study of Autism Spectrum Disorder and ASD, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT03900923 is a Phase 2 study of Autism Spectrum Disorder and ASD that has completed, run by NYU Langone Health. The registered enrollment target is 29 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03900923, a Phase 2 study of Autism Spectrum Disorder and ASD, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 6-week open trial to identify the optimal dosing of cannabidiol (CBD) in youth with autism spectrum disorder (ASD) and to identify primary and secondary outcomes for future controlled studies. This study evaluates change in symptoms commonly associated with ASD, as evidence suggests that CBD may be effective in addressing difficulties such as irritability and anxiety, while maintaining a benign adverse effect (AE) profile in children and adolescents. 30 male and female participants with ASD between the ages of 7 and 17 years old are being recruited. Participants have fluent speech and an estimated IQ greater than or equal to 80. Study intervention is 98% pure CBD. The CBD is Greenwich Biosciences, Inc.'s 100mg/mL oral solution, brand name EPIDIOLEX. First, a Bayesian optimal interval (BOIN) design was used, such that participants were assigned to cohorts of size 3 receiving doses of 3, 6, or 9 mg/kg/day, depending on the treatment response of participants in prior cohorts. The BOIN design ended after the fifth cohort of participants, and the two lower doses, 3 and 6 mg/kg/day, were eliminated. The highest dose, 9 mg/kg/day, was not tested. Therefore, in subsequent cohorts, we will be examining 9 mg/kg/day exclusively in up to 15 additional participants with co-occurring ASD and attention-deficit/hyperactivity disorder (ADHD) diagnoses, as this clinical profile appears to most closely resemble youth classified as responders within the BOIN design.
Conditions Studied
Interventions
- DRUG 98% pure CBD
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2019-03-12 |
| Est. Completion | 2023-05-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03900923
The ClinicalTrials.gov registry entry for NCT03900923 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (79% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which 98% pure CBD is the first listed.
NCT03900923 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03900923 about?
NCT03900923 is a clinical study titled "Cannabidiol for ASD Open Trial". This is a 6-week open trial to identify the optimal dosing of cannabidiol (CBD) in youth with autism spectrum disorder (ASD) and to identify primary and secondary outcomes for future controlled studies. This study evaluates change in symptoms commonly associated with ASD, as evidence suggests that C...
What is the current status of trial NCT03900923?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2019-03-12. Estimated completion is 2023-05-04.
What conditions does trial NCT03900923 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, ASD.
What interventions are being tested in trial NCT03900923?
The interventions under investigation include: 98% pure CBD (DRUG).
Who is sponsoring clinical trial NCT03900923?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03900923 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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