Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial (CAN-CHA)

A Multi-Centre, Tolerability Study of a Cannabidiol-enriched Cannabis Herbal Extract for Chronic Headaches in Adolescents: the CAN-CHA Trial

Chronic headaches are a major cause of disability among adolescents. Cannabis products have supported the management of headaches in adults and may play a role in pediatric chronic pain. We propose a multisite, open-label, tolerability study conducted across three centers in Canada of Cannabidiol-enriched Cannabis Herbal Extract in adolescents (ages 14 to 17 years old) with chronic headaches. The study includes a one month baseline assessment, four months of escalating treatment doses and a weaning period. Our primary outcome is tolerability defined as the number and severity of reported adverse events.

Study Overview

• Status: Recruiting
• Conditions: Chronic Migraine
• Intervention / Treatment: Drug: MPL-001

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lauren E Kelly, PhD; Phone Number: 2042723149; Email: lauren.kelly@umanitoba.ca
• Study Contact Backup: Name: Lauren Kelly; Phone Number: 2042723149; Email: lauren.kelly@umanitoba.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T1Z4
      • Not yet recruiting
      • University of British Columbia
      • Contact: Dr. Tim Oberlander, MD, FRCPC
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Not yet recruiting
      • Dalhousie University-
      • Contact: Dr. G Allen Finley, MD, FRCPC, FAAP
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • North Toronto Neurology
      • Contact: Dr. Evan C. Lewis, MD, FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. Adolescents aged between 14-17 years of age at the time of screening.
2. Diagnosed with Chronic Migraine according to ICHD-3: headache (migraine-like or tension-type like) occurring on 15 or more days per month for more than 3 months which on at least 8 days per month have features of migraine headache. [121]
3. Failed at least two treatment options on the grounds of safety (tolerability) and/or efficacy, including but not limited to antidepressant (tricyclic antidepressant or selective norepinephrine reuptake inhibitor), magnesium, gabapentinoids topiramate and/or non-pharmacological therapies.
4. Females who have reached menarche should have a negative pregnancy test during screening.
5. Must be willing to engage with psychology and physiotherapy throughout the trial as appropriate.

Exclusion Criteria:

1. As per the investigator judgement, the participant is not an ideal candidate due to a personal issue or medical condition that is likely to impede in the successful completion of the study
2. Participants with a history of post-concussion headache or new daily persistent headache
3. Participants with a diagnosis of medication overuse headache
4. Participants with cardiac, renal or hepatic disease (assessed by the site investigator)
5. Participants with complex regional pain syndrome-II
6. Participants with abnormal ECG findings at baseline (as determined by the investigator)
7. Participants who are on the following medications: opioids, antipsychotics, antimanic, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol.
8. Participants with developmental delay or impairments including autism, cerebral palsy or intellectual disability.
9. Participants with a personal or family history of schizophrenia or psychotic disorders
10. Participants who are pregnant or breast/chest-feeding or plans to become pregnant within the study period or within three months of interventional product discontinuation
11. Participants who cannot commit to using contraception and refraining from recreational cannabis use and driving throughout the study period
12. Participants with known allergy to cannabinoids and/or palm/coconut oil

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cannabidiol-enriched Cannabis Herbal Extract; CBD50 plus

Drug: MPL-001; CBD50 plus is a medical cannabis oil with flavouring agent produced under Good Manufacturing Practice by MediPharm Labs and purchased for this study. Each ml of oil contains 2 mg/ml of delta-9-THC and 50 mg/ml of CBD. Participants will receive escalating doses from 0.2-0.4 mg/kg/day of CBD to 0.8-1 mg/kg of CBD per day for four months, with dose increases monthly in 0.2mg/kg increments. Participants will following a weekly weaning protocol.; Other Names: medical cannabis oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cannabis-related adverse events	The frequency of adverse events will be measured and characterized using standard CTCAE coding	Reported daily through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency and duration of headache compared to baseline	Reported headache frequency and duration daily and reported as a monthly average documented at baseline.	Reported daily through study completion, an average of 6 months
Pain intensity compared to baseline	The average intensity measured using a Numeric Rating Scale (NRS) will be reported as a percentage change from the monthly average documented at baseline and an increasing score(highest score =10) indicates a greater severity of pain.	Reported daily through study completion, an average of 6 months
Pain impact on participants quality of life compared to baseline	The impact of pain on participants quality of life using the PROMIS Pediatric Pain Interference- Short Form 8a will be reported as a percentage change from the monthly average documented at baseline.	Reported monthly for 6 months
Number of hours of sleep per night compared to baseline	The number of hours of sleep per night will be measured using a actigraphy device	Reported daily through study completion, an average of 6 months
Change in mood, depression from baseline	PROMIS Pediatric Short Form v2.0 - Depressive Symptoms 8a scale as a percentage change from the monthly average documented at baseline	Reported monthly for 6 months
Change in mood, positive affect from baseline	Change in mood, positive affect will be evaluated using PROMIS Pediatric Positive Affect - Short Form 8 and reported as a percentage change from the monthly average documented at baseline	Reported monthly for 6 months
Change in self-directed goal attainment from baseline	Participants will self-directed goal attainment (participant and parent reported) as a percentage of goal attained at each study visit	Reported monthly for 6 months
Changes in anxiety compared to baseline	Changes in anxiety will be measured using the PROMIS Pediatric Anxiety Short Form v2.0 and reported as percentage change from the monthly average documented at baseline	Reported monthly for 6 months
Change in sleep quality	Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Short Form v 2.0 - Pediatric Sleep-Related Impairment 8a scale as a percentage change from the monthly average documented at baseline where a higher number indicates a more sleep related impairment	Reported monthly for 6 months

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: SickKids Foundation
• Investigators: Principal Investigator: Lauren E Kelly, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Adolescents; Children; Migraine; Cannabis; Cannabidiol; Tetrahydrocannbinol
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache
• Other Study ID Numbers: CAN-CHA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No