Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
- Conditions
- Chronic Migraine
- Interventions
- Drug: MPL-001
- Registration Number
- NCT05337033
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
To be eligible to participate in this study, an individual must meet all of the following criteria:
- Adolescents between 14-17 years of age at the time of screening
- Diagnosed with chronic migraine for more than three months
- 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.
- Females who have reached menarche should have a negative serum pregnancy test during screening.
- Must be willing to engage with psychology and physiotherapy throughout the trial
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cannabidiol-enriched Cannabis Herbal Extract MPL-001 CBD50 plus
- Primary Outcome Measures
Name Time Method Cannabis-related adverse events Reported daily through study completion, an average of 6 months The frequency of adverse events will be measured and characterized using standard CTCAE coding
- Secondary Outcome Measures
Name Time Method Pain intensity compared to baseline Reported daily through study completion, an average of 6 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.
Changes in anxiety compared to baseline Reported monthly for 6 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
Pain impact on participants quality of life compared to baseline Reported monthly for 6 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.
Number of hours of sleep per night compared to baseline Reported daily through study completion, an average of 6 months The number of hours of sleep per night will be measured using a actigraphy device
Change in mood, positive affect from baseline Reported monthly for 6 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
Change in self-directed goal attainment from baseline Reported monthly for 6 months Participants will self-directed goal attainment (participant and parent reported) as a percentage of goal attained at each study visit
The frequency and duration of headache compared to baseline Reported daily through study completion, an average of 6 months Reported headache frequency and duration daily and reported as a monthly average documented at baseline.
Change in sleep quality Reported monthly for 6 months 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
Change in mood, depression from baseline Reported monthly for 6 months PROMIS Pediatric Short Form v2.0 - Depressive Symptoms 8a scale as a percentage change from the monthly average documented at baseline
Trial Locations
- Locations (3)
Neurology Centre of Toronto
🇨🇦Toronto, Ontario, Canada
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Dalhousie University-
🇨🇦Halifax, Nova Scotia, Canada