Medical Cannabis Registry and Pharmacology
Med Can Autism
1 other identifier
observational
119
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2018
CompletedFirst Submitted
Initial submission to the registry
September 12, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2020
CompletedJanuary 27, 2020
January 1, 2020
1.5 years
September 12, 2018
January 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
Number of families who complete the educational program to assess epidemiologic outcomes
5 years
Interventions
This is an observational trial
Eligibility Criteria
Those diagnosed with autism who are under age 21.
You may qualify if:
- Individuals who consume cannabis products in a state which has legalized medical cannabis for the treatment of ASD related symptoms
- Individuals who have a diagnosis of autism spectrum disorder
You may not qualify if:
- Consumption of cannabis products that are not obtained legally
- Non English speaking individuals
- Greater than 21 years of age for entry into Part 2 of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Philadelphialead
- Zelda Therapeuticscollaborator
Study Sites (1)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Athena Zuppa, MD, MSCE
Children's Hospital of Philadelphia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2018
First Posted
October 9, 2018
Study Start
July 15, 2018
Primary Completion
January 15, 2020
Study Completion
January 15, 2020
Last Updated
January 27, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share