drugset / Trial / NCT05337033

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

NCT05337033 ↗

Phase 2 Recruiting 20 enrolled University of Manitoba SickKids Foundation · collab
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

EvaluationDrugModalityDoseRoute
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 —

Indications