JAMA Neurology

Add-on Cannabidiol Treatment for Drug-Resistant Seizures in Tuberous Sclerosis Complex

A Placebo-Controlled Randomized Clinical Trial

15 March, 2021

Thiele EA, Bebin EM, Bhathal H, et al.

Jama Neurology 2021;78(3):285–292. doi:10.1001/jamaneurol.2020.4607

Key Points

Is add-on cannabidiol superior to placebo in reducing the number of seizures associated with tuberous sclerosis complex?

In this randomized clinical trial, 224 patients with tuberous sclerosis complex were treated with cannabidiol (25 or 50 mg/kg/day) or matched placebo for 16 weeks. The percentage reduction in the type of seizures regarded as the primary end point was 27% for placebo, 49% for 25 mg/kg/day of cannabidiol, and 48% for 50 mg/kg/day of cannabidiol; a dosage of 25 mg/kg/day led to fewer adverse events than the 50-mg/kg/day dosage.

In this study, both cannabidiol dosages were equally efficacious in reducing tuberous sclerosis complex–associated seizures compared with placebo, but the smaller dosage led to fewer adverse events.