Real World Evidence on the Use of Medical Cannabis in Pediatrics

Study Purpose

CAN-RWE is an observational study that is following 500 children who have authorizations for medical cannabis for two years from across Canada.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 3 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 3 to 17 years.
  • - have a medical document provided by a prescribing health care practitioner (i.e. physician, nurse practitioner, etc.) for the use of medical cannabis.
  • - medical cannabis is authorized for pain, sleep, mood, behaviour, seizures, cancer or cancer-treatment related symptom management.
  • - ability to respond to electronic questionnaires in English.

Exclusion Criteria:

  • - individuals using cannabis for medical purposes without a medical cannabis authorization from a health care provider.
- those only using cannabis recreationally

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05863910
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Manitoba
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sapna Oberoi, MDTaylor Lougheed, MDEvan Lewis, MD
Principal Investigator Affiliation University of ManitobaNorthern Ontario School of MedicineNeurology Centre of Toronto
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cancer, Epilepsy, Neurodevelopmental Disorders
Study Website: View Trial Website
Additional Details

Pediatric patients (3 to 17 years) using medical cannabis (MC) for pain, sleep, mood, behaviour, seizures, treatment of cancer, or to manage symptoms related to cancer or cancer-treatment are eligible to join this 24-month study if they have a valid MC authorization. Following screening, eligible participants will be contacted by the study coordinator. Following informed consent, study participants will record complete outcome measures on pain, sleep, mood (anxiety, depression and positive affect), behaviour, as well as report their cannabis use and indication-specific outcomes as applicable at 3, 6, 12, and 18 weeks, as well as 6, 12, 18 and 24-months.

Arms & Interventions

Arms

: Epilepsy Cohort

For children with epilepsy, the following tools will be added for data collection at each time point: - Side effects: Pediatric Epilepsy Side Effects Questionnaire [PESQ] - Seizure frequency/severity: Seizure Diary Data Questionnaire

: Cancer Cohort

For children with cancer, the following tools will be added for data collection at each time point: - Cancer symptom burden: Symptom Screening in Pediatrics Tool [SSPedi] - Cachexia: Pediatric Functional Assessment of Anorexia/ Cachexia Treatment [peds-FAACT]

: General Pediatrics Cohort

There are no specific outcome scales added for this cohort.

Interventions

Drug: - Medical Cannabis

Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

U Manitoba, Winnipeg 6183235, Manitoba 6065171, Canada

Status

Recruiting

Address

U Manitoba

Winnipeg 6183235, Manitoba 6065171, R3E0T6

Site Contact

Lauren Kelly, PhD

[email protected]

2042723149

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