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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05337033
Recruitment Status : Not yet recruiting
First Posted : April 20, 2022
Last Update Posted : November 21, 2022
Sponsor:
Collaborators:
SickKids Foundation
The Canadian Collaborative for Childhood Cannabinoid Therapeutics (C4T)
Information provided by (Responsible Party):
Lauren Kelly, University of Manitoba

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Drug: MPL-001 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label tolerability trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Centre, Tolerability Study of a Cannabidiol-enriched Cannabis Herbal Extract for Chronic Headaches in Adolescents: the CAN-CHA Trial
Estimated Study Start Date : February 1, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Marijuana

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 Name: medical cannabis oil




Primary Outcome Measures :
  1. Cannabis-related adverse events [ Time Frame: Reported daily through study completion, an average of 7 months ]
    The frequency of adverse events will be measured and characterized using standard CTCAE coding


Secondary Outcome Measures :
  1. The frequency and duration of headache compared to baseline [ Time Frame: Reported daily through study completion, an average of 7 months ]
    Reported headache frequency and duration daily and reported as a monthly average documented at baseline.

  2. Pain intensity compared to baseline [ Time Frame: Reported daily through study completion, an average of 7 months ]
    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.

  3. Pain impact on participants quality of life compared to baseline [ Time Frame: Reported monthly for 7 months ]
    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.

  4. Number of hours of sleep per night compared to baseline [ Time Frame: Reported daily through study completion, an average of 7 months ]
    The number of hours of sleep per night will be measured using a actigraphy device

  5. Change in mood, depression from baseline [ Time Frame: Reported monthly for 7 months ]
    PROMIS Pediatric Short Form v2.0 - Depressive Symptoms 8a scale as a percentage change from the monthly average documented at baseline

  6. Change in mood, positive affect from baseline [ Time Frame: Reported monthly for 7 months ]
    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

  7. Change in self-directed goal attainment from baseline [ Time Frame: Reported monthly for 7 months ]
    Participants will self-directed goal attainment (participant and parent reported) as a percentage of goal attained at each study visit

  8. Changes in anxiety compared to baseline [ Time Frame: Reported monthly for 7 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  1. Adolescents between 14-17 years of age at the time of screening
  2. Diagnosed with chronic migraine for more than three months
  3. Failed other treatment options on the grounds of safety (tolerability) or efficacy, including but not limited to antidepressants (tricyclic antidepressant or selective norepinephrine reuptake inhibitor), gabapentinoids or topiramate.
  4. Females who have reached menarche should have a negative serum pregnancy test during screening.
  5. Must be willing to engage with psychology and physiotherapy throughout the trial

Exclusion Criteria:

Adolescents meeting any of the following criteria will be excluded from the study:

  1. As per investigator judgment, the participant is not an ideal candidate due to a personal issue or medical condition that is likely to impede successful completion of the study
  2. Participants with a history of post-concussion headache
  3. Participants with a diagnosis of medication overuse headache or tension-type headache
  4. Participants with cardiac, renal, or hepatic disease (assessed by the site investigator)
  5. Participants with other chronic pain conditions including complex regional pain syndrome-II
  6. Participants with abnormal ECG findings at baseline
  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 who are pregnant or breastfeeding or those who cannot commit to using two forms of contraception or those who plan to become pregnant within the study timeframe.
  10. Participants with a family history of psychotic disorders or schizophrenia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05337033


Contacts
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Contact: Lauren E Kelly, PhD 2042723149 lauren.kelly@umanitoba.ca
Contact: Lauren Kelly 2042723149 lauren.kelly@umanitoba.ca

Locations
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Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T1Z4
Contact: Dr. Tim Oberlander, MD, FRCPC         
Canada, Nova Scotia
Dalhousie University-
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Dr. G Allen Finley, MD, FRCPC, FAAP         
Canada, Ontario
Neurology Centre of Toronto
Toronto, Ontario, Canada
Sponsors and Collaborators
University of Manitoba
SickKids Foundation
The Canadian Collaborative for Childhood Cannabinoid Therapeutics (C4T)
Investigators
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Principal Investigator: Lauren E Kelly, PhD University of Manitoba
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Responsible Party: Lauren Kelly, Lauren E Kelly PhD, MSc, BMedSci, CCRP, Assistant Professor, Dept. of Pediatrics & Child Health, University of Manitoba Scientific Director, Canadian Childhood Cannabinoid Clinical Trials (www.C4Trials.org), University of Manitoba
ClinicalTrials.gov Identifier: NCT05337033    
Other Study ID Numbers: CAN-CHA
First Posted: April 20, 2022    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lauren Kelly, University of Manitoba:
Adolescents
Children
Cannabis
Migraine
Cannabidiol
Tetrahydrocannbinol
Additional relevant MeSH terms:
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Headache Disorders
Headache
Marijuana Abuse
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders