drugset / Trial / NCT05337033
Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-10-11
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MPL-001 | Traditional medicine (herbal / TCM) | 0.2 mg/kg | — |
| Subject | MPL-001 | Traditional medicine (herbal / TCM) | 0.4 mg/kg | — |
| Subject | MPL-001 | Traditional medicine (herbal / TCM) | 0.6 mg/kg | — |
| Subject | MPL-001 | Traditional medicine (herbal / TCM) | 0.8 mg/kg | — |
| Subject | MPL-001 | Traditional medicine (herbal / TCM) | 1 mg/kg | — |