Chronic Migraine
Conditions
Keywords
Adolescents, Children, Cannabis, Migraine, Cannabidiol, Tetrahydrocannbinol
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.
Interventions
DRUGMPL-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.
Sponsors
SickKids Foundation
University of Manitoba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label tolerability trial
Eligibility
Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
No
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 11. Participants who cannot commit to using contraception and refraining from recreational cannabis use and driving throughout the study period 12. Participants with known allergy to cannabinoids and/or palm/coconut oil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 |
| 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 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 |
| 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 |
| 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 |
Countries
Canada
Contacts
Primary ContactLauren E Kelly, PhD
Backup ContactLauren Kelly
Outcome results
None listed