Real World Evidence on the Use of Medical Cannabis in Pediatrics

NCT05863910 | Recruiting

• 1 other identifier: CAN-RWE
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer; Epilepsy; Neurodevelopmental Disorders

Keywords

cannabinoids; cannabis; pediatrics

Outcome Measures

Primary Outcomes (1)

• Patterns of cannabis use (caregiver-reported)

  Describe patterns of cannabis use are described using a standard data collection form including dose and product type completed by caregivers at baseline, 3, 6, 12, and 18-weeks and 6, 12, 18 and 24-months

  baseline to 24-months

Secondary Outcomes (12)

• Effectiveness in seizure cohort - seizure frequency

  baseline to 24-months

• Effectiveness in seizure cohort - QOLCE

  baseline to 24-months

• Effectiveness in oncology cohort - symptom burden

  baseline to 24-months

• Effectiveness in oncology cohort - cachexia

  baseline to 24-months

• Adverse events

  baseline to 24-months

Study Arms (3)

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

Drug: Medical Cannabis

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 \[peds-FAACT\]

Drug: Medical Cannabis

General Pediatrics Cohort

There are no specific outcome scales added for this cohort.

Drug: Medical Cannabis

Interventions

Medical Cannabis DRUG

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

Cancer Cohort; Epilepsy Cohort; General Pediatrics Cohort

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Population includes children (3 to 17 years) who are cannabis-naïve or experienced with a medical document provided by a prescribing health care practitioner (i.e. physician, nurse practitioner, etc.) for the use o medical cannabis primarily for pain, sleep, mood, behaviour, seizures, cancer or cancer-treatment related symptom management.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead
• The Canadian Collaborative for Childhood Cannabinoid Therapeutics: collaborator
• Canadian Cancer Society (CCS): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

U Manitoba

Winnipeg, Manitoba, R3E0T6, Canada

RECRUITING

Related Links

• For more information on our research team visit our website.

MeSH Terms

Conditions

Neoplasms; Epilepsy; Neurodevelopmental Disorders; Marijuana Abuse

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Sapna Oberoi, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Taylor Lougheed, MD

  Northern Ontario School of Medicine

  PRINCIPAL INVESTIGATOR

• Evan Lewis, MD

  Neurology Centre of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren E Kelly, PhD

CONTACT

2042723149; lauren.kelly@umanitoba.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: May 18, 2023
• Study Start: November 20, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

CA (1)