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Chronic MigrainePhase 2CAN-CHANCT05337033

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

A Phase 2 study testing MPL-001 in people with Chronic Migraine, run by University of Manitoba at 3 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 17 years
Conditions the study is for
Chronic Migraine
What is being tested?
MPL-001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesCanada
Study dates
11 Oct 2024to 31 Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 12Show fewer
  • 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
  • Participants with known allergy to cannabinoids and/or palm/coconut oil

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lauren E Kelly, PhD contact

2042723149

lauren.kelly@umanitoba.ca

Lauren Kelly contact

2042723149

lauren.kelly@umanitoba.ca

Canada3 sites, 3 recruiting

  • Dalhousie University-

    Halifax, Nova Scotia, B3K 6R8

    Dr. G Allen Finley, MD, FRCPC, FAAP

    Not yet recruiting

  • North Toronto Neurology

    Toronto, Ontario

    Dr. Evan C. Lewis, MD, FRCPC

    Recruiting

  • University of British Columbia

    Vancouver, British Columbia, V6T1Z4

    Dr. Tim Oberlander, MD, FRCPC

    Not yet recruiting

Other trials in Canada

About this study

Official title: 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.

Being tested
MPL-001
Keywords
Adolescents, Children, Cannabis, Migraine, Cannabidiol, Tetrahydrocannbinol
Medical subject headings
Marijuana Abuse, Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MPL-001Drug

    Also called medical cannabis oil

    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.

Study groups in NCT05337033
Study groupRoleWhat they receive
Cannabidiol-enriched Cannabis Herbal ExtractExperimentalCBD50 plus
Receives: Drug: MPL-001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cannabis-related adverse events

    The frequency of adverse events will be measured and characterized using standard CTCAE coding

    Measured: Reported daily through study completion, an average of 6 months

Secondary outcomes (9)

  1. The frequency and duration of headache compared to baseline

    Reported headache frequency and duration daily and reported as a monthly average documented at baseline.

    Measured: Reported daily through study completion, an average of 6 months

  2. 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.

    Measured: Reported daily through study completion, an average of 6 months

  3. 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.

    Measured: Reported monthly for 6 months

  4. 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

    Measured: Reported daily through study completion, an average of 6 months

  5. 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

    Measured: Reported monthly for 6 months

  6. 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

    Measured: Reported monthly for 6 months

  7. 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

    Measured: Reported monthly for 6 months

  8. 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

    Measured: Reported monthly for 6 months

  9. 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

    Measured: Reported monthly for 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start11 Oct 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label tolerability trial
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05337033
Sponsor's protocol ID
CAN-CHA
Acronym
CAN-CHA
Status last verified
May 2025
First submitted
29 Mar 2022
Last updated
29 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chhabra M, Lewis EC, Balshaw R, Stewart B, Zaslawski Z, Lowthian T, Alidina Z, Chesick-Gordis M, Xie W, Drogemoller BI, Wright GEB, Birnie KA, Boerner KE, Tsang VWL, Irwin SL, Pohl D, Weil AG, Sell E, Penz E, Robson-MacKay A, Mbabaali S, Blackman S, Gordon S, Alcorn J, Huntsman RJ, Oberlander TF, Finley GA, Kelly LE. A multi-centre, tolerability study of a cannabidiol-enriched Cannabis Herbal Extract for chronic headaches in adolescents: The CAN-CHA protocol. PLoS One. 2024 Sep 20;19(9):e0290185. doi: 10.1371/journal.pone.0290185. eCollection 2024.

    PubMed 39302982

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MPL-001 in people with Chronic Migraine, run by University of Manitoba at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lauren E Kelly, PhD (2042723149, lauren.kelly@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cannabis-related adverse events (time frame: Reported daily through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05337033, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.

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