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

Chronic Migraine Clinical Trial

— CAN-CHA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337033
• Other study ID #: CAN-CHA
• Status: Recruiting
• Phase: Phase 1
• Start date: November 27, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: University of Manitoba
• Contact: Lauren E Kelly, PhD
• Phone: 2042723149
• Email: lauren.kelly[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Chronic Migraine
• Headache
• Headache Disorders

Intervention

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.

Locations

Country	Name	City	State
Canada	Dalhousie University-	Halifax	Nova Scotia
Canada	Neurology Centre of Toronto	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	SickKids Foundation, The Canadian Collaborative for Childhood Cannabinoid Therapeutics (C4T)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannabis-related adverse events	The frequency of adverse events will be measured and characterized using standard CTCAE coding	Reported daily through study completion, an average of 6 months
Secondary	The frequency and duration of headache compared to baseline	Reported headache frequency and duration daily and reported as a monthly average documented at baseline.	Reported daily through study completion, an average of 6 months
Secondary	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.	Reported daily through study completion, an average of 6 months
Secondary	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.	Reported monthly for 6 months
Secondary	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	Reported daily through study completion, an average of 6 months
Secondary	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	Reported monthly for 6 months
Secondary	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	Reported monthly for 6 months
Secondary	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	Reported monthly for 6 months
Secondary	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	Reported monthly for 6 months
Secondary	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	Reported monthly for 6 months