NCT03699527|Completed
Medical Cannabis Registry and Pharmacology
Med Can Autism
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Med Can Autism
Sponsor study identifier
observational
119
1 country
1
Study Start
July 15, 2018
Actual (reported)Primary Completion
January 15, 2020
Actual (reported)Study Completion
January 15, 2020
Actual (reported)The overall goals of this research is to describe the 1) natural history of current use and disposition of medical cannabis products including Cannabidiol (CBD) products, being administered to children as standard of care for the treatment of Autism Spectrum Disorder (ASD), 2) understand the pharmacokinetic and pharmacodynamics of medical cannabis products and 3) provide educational feedback on what is learned to families and care providers to provide evidenced based dosing guidance for these products to the pediatric community.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 15, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 15, 2018
Actual (reported)September 12, 2018
Actual (reported)October 9, 2018
Actual (reported)January 15, 2020
Actual (reported)January 15, 2020
Actual (reported)Number of children with ASD who use medical cannabis
The primary objective is to create a registry that will describe the natural history and landscape of medical cannabis and CBD use in the pediatric ASD population.
5 years
Maximum Cannabinoid concentrations in pediatric patients with ASD
The PK profile of select medical cannabis products in pediatric patients with ASD will be assessed. PK sampling may be performed in the home or at a CHOP site. All Subjects will undergo PK sampling at predetermined times for the determination of cannabinoid concentrations based on the formulation that is being consumed (e.g. If a subject is taking only CBD, Tetrahydrocannabinol (THC) concentrations will not be measured). PK samples will be obtained either using a micro-sampling approach (home or CHOP) or from an indwelling catheter (CHOP site
5 years
Number of families who complete the educational program to assess epidemiologic outcomes
5 years
This is an observational trial
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Those diagnosed with autism who are under age 21.
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Athena Zuppa, MD, MSCE
Children's Hospital of Philadelphia
119 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2018
First Posted
October 9, 2018
Study Start
July 15, 2018
Actual (reported)Intranasal Vasopressin Treatment in Children With Autism
Building Social Skills With Interdisciplinary Process Drama in ASD
Contact the study team to confirm eligibility.
Primary Completion
January 15, 2020
Actual (reported)Study Completion
January 15, 2020
Actual (reported)Last Updated
January 27, 2020
Record last verified: 2020-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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