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Trial record 3 of 4 for:    cannabinoids | Autism

Medical Cannabis Registry and Pharmacology (Med Can Autism)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03699527
Recruitment Status : Completed
First Posted : October 9, 2018
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Zelda Therapeutics
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Tracking Information
First Submitted Date September 12, 2018
First Posted Date October 9, 2018
Last Update Posted Date January 27, 2020
Actual Study Start Date July 15, 2018
Actual Primary Completion Date January 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 5, 2018)
  • Number of children with ASD who use medical cannabis [ Time Frame: 5 years ]
    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.
  • Maximum Cannabinoid concentrations in pediatric patients with ASD [ Time Frame: 5 years ]
    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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 5, 2018)
Number of families who complete the educational program to assess epidemiologic outcomes [ Time Frame: 5 years ]
Families will be informed of epidemiologic outcomes through an educational program for families that have participated in the research for those families who opt for this component. Although these are not research in nature, they are a direct result of the proposed research and are included in the protocol to demonstrate the study's deliverables.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Medical Cannabis Registry and Pharmacology
Official Title Medical Cannabis Registry and Pharmacology
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.
Detailed Description

Part 1 of the study will consist of building a patient registry. Eligible patients will be identified and consented for study participation.Parents/legal guardians will be asked the survey related questions from Social Communication Questionnaire (SCQ), personality structure questionnaire (PSQ), Assessment Battery for Children (ABC2), Behavior Rating Inventory of Executive Function (BRIEF2), and the Screen for Child Anxiety Related Disorders (SCARED) (parent version) if appropriate and ASHD5 Rating for either 5-10 year old or 11-17 year old. The description of each survey is below with a link to more information to the ASHD5. All additional questionnaires are already validated by the Institutional Review Board (IRB).

Registry information (as detailed below) will be gathered and entered into the registry.Each subject will be re-contacted approximately every 12 weeks to ask whether medications (cannabis related or other) have changed, efficacy/side effects have changed, or there have been changes in care or medical history. These new data will be recorded in the registry. Subjects may continue in the study for the duration of medical cannabis use, until they remove themselves from the study, or the study closes. All data will remain coded with a Master log of Subject identification numbers (IDs).

Part 2 of the study consists of pharmacokinetic (PK) evaluation of select subjects.

PK sampling of a select formulations will begin subjects are enrolled into the Registry and have consented to PK sampling. . Subjects will have the opportunity to opt in or out of Part 2 upon the initial informed consent process for Part 1.

Part 3 of study related activities will include analysis and summary of the data on approximately a six month basis.

The investigative team will provide study participants with coded summary statistics of medical cannabis products use in the region (either through email, postal mail). This will also be presented at a community-based meeting that all study participants are invited to attend. The study team recognized that participation in a community event will result in loss of de-identification, but also feel that this will occur on a voluntary basis for all study participants.

The study team hypothesizes that the community educational programs will provide study participants an opportunity to connect with others in the community, share concerns, learn from others and allow the development of community-based support systems.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Those diagnosed with autism who are under age 21.
Condition
  • Autism
  • ASD
Intervention Behavioral: Multiple questionnaires administered
This is an observational trial
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 22, 2020)
119
Original Estimated Enrollment
 (submitted: October 5, 2018)
200
Actual Study Completion Date January 15, 2020
Actual Primary Completion Date January 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria

  1. Individuals who consume cannabis products in a state which has legalized medical cannabis for the treatment of ASD related symptoms
  2. Individuals who have a diagnosis of autism spectrum disorder

Exclusion Criteria

  1. Consumption of cannabis products that are not obtained legally
  2. Non English speaking individuals
  3. Greater than 21 years of age for entry into Part 2 of the study
Sex/Gender
Sexes Eligible for Study: All
Ages up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03699527
Other Study ID Numbers 17-014628
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Children's Hospital of Philadelphia
Study Sponsor Children's Hospital of Philadelphia
Collaborators Zelda Therapeutics
Investigators
Principal Investigator: Athena Zuppa, MD, MSCE Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date January 2020