Plant-derived cannabinoids for treatment of spasticity in children and adolescents with severe cerebral palsy: Double-blind, placebo-controlled trial.

Background: To assess the efficacy, safety, and tolerability of full-spectrum cannabis oil (FSCO) (CBD:THC ratio of 10:1) for the treatment of spasticity in individuals with spastic cerebral palsy (CP) grades IV and V. Method: A pilot trial to assess the feasibility of FSCO in seven CP patients was followed by a prospective double-blind, placebo-controlled parallel trial, with 53 participants aged 5-25 years, randomised in a 1:1 ratio. The double-blind phase lasted six weeks, followed by the open-label phase of six weeks' duration. The primary endpoint was a change in spasticity measured by the modified Ashworth Scale. Secondary outcomes were changes in motor function (Gross Motor Function Measure 88 scale), quality of life, safety, and tolerability. Results: There was no significant difference in spasticity, motor function, and quality of life parameters between patients receiving FSCO or placebo. Patients in the FSCO group were significantly drowsier compared to the placebo group. Adverse events were mild to moderate; there were no life-threatening events. Interpretation: This trial suggests FSCO treatment in children with CP is generally well tolerated and safe. It might have benefits on quality of life. No significant change in spasticity was demonstrated with FSCO treatment compared to the placebo.