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Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT05337033•University of Manitoba

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

14 - 17 years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (3)

University of British Columbia

Vancouver, British Columbia, Canada

Dalhousie University-

Halifax, Nova Scotia, Canada

North Toronto Neurology

Toronto, Ontario, Canada

Key Dates

Start Date

October 11, 2024

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

May 29, 2025

Enrollment

ESTIMATED participants

Conditions

Chronic Migraine

Interventions

MPL-001

DRUG

Contacts

Lauren E Kelly, PhD

CONTACT

2042723149 lauren.kelly@umanitoba.ca

Lauren Kelly

CONTACT

2042723149 lauren.kelly@umanitoba.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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