Who is eligible for clinical trial NCT05337033?

Participants must meet the protocol's inclusion criteria for Chronic Migraine. The stated age range is 14 Years to 17 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05337033 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-05-22

Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial (NCT05337033)

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: University of Manitoba

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (13 items).

Location: University of British Columbia — Vancouver, British Columbia

Age range: 14 Years to 17 Years

🧪 Interventions in This Study

MPL-001 (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

To be eligible to participate in this study, an individual must meet all of the following criteria:
Adolescents aged between 14-17 years of age at the time of screening.
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. \[121\]
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.
Females who have reached menarche should have a negative pregnancy test during screening.
Must be willing to engage with psychology and physiotherapy throughout the trial as appropriate.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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
Participants with a history of post-concussion headache or new daily persistent headache
Participants with a diagnosis of medication overuse headache
Participants with cardiac, renal or hepatic disease (assessed by the site investigator)
Participants with complex regional pain syndrome-II
Participants with abnormal ECG findings at baseline (as determined by the investigator)
Participants who are on the following medications: opioids, antipsychotics, antimanic, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol.
Participants with developmental delay or impairments including autism, cerebral palsy or intellectual disability.
Participants with a personal or family history of schizophrenia or psychotic disorders
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
Participants who cannot commit to using contraception and refraining from recreational cannabis use and driving throughout the study period

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

University of British Columbia — Vancouver, British Columbia
Dalhousie University- — Halifax, Nova Scotia
North Toronto Neurology — Toronto, Ontario

📞 Contact the Study Coordinator

Phone: (204) 272-3149

Email: lauren.kelly@umanitoba.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Chronic Migraine

A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults — Birmingham, Alabama
BOTOX® vs. XEOMIN® for Chronic Migraine — Jacksonville, North Carolina
Cannabis for the Prophylactic Treatment of Migraine — Calgary, Alberta
Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo) — Ann Arbor, Michigan
A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years — Huntsville, Alabama

Explore by condition: All Chronic Migraine clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗