Cannabidiol in conjunction with clobazam: analysis of four randomized controlled trials.

ABSTRACT:

Objectives

To assess the efficacy and safety profile of add-on cannabidiol (CBD) in patients with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) on clobazam and in the overall population of four randomized, controlled phase 3 trials.

Methods

Patients received plant-derived, highly purified CBD medicine (Epidiolex^® in the USA; Epidyolex^® in Europe; 100 mg/ml oral solution) at a dose of 10 or 20 mg/kg/day, or placebo for 14 weeks. A subgroup analysis of patients on clobazam and meta-analysis by syndrome were conducted. The primary endpoint was percentage reduction in primary seizure type during the treatment period.

Results

396 patients with LGS (49% on clobazam) and 318 patients with DS (64% on clobazam) were included. CBD treatment result

SUBMITTER: Gunning B 

PROVIDER: S-EPMC7821324 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature