Cannabidiol for Lennox–Gastaut syndrome takes effect within a week
The effect of cannabidiol (CBD) in the treatment of patients with Lennox–Gastaut syndrome may occur within 7 days of initiation, and most adverse events (AEs) resolve within a 14-week period, a study reports.
Researchers conducted a posthoc analysis of data from two randomized, placebo‐controlled, phase III trials, GWPCARE3 and GWPCARE4. The total population included 235 patients who received highly purified CBD formulation (100 mg/ml oral solution) at 10 mg/kg/day (CBD10; GWPCARE3; n=67) or 20 mg/kg/day (CBD20; both trials; n=168) and 161 who were given placebo.
Treatment lasted 14 weeks, starting at 2.5 mg/kg/day for all groups and reaching 10 mg/kg/day on day 7 and 20 mg/kg/day (CBD20 and matching placebo only) on day 11.
The mean age of the population was 15.3 years. Patients had previously discontinued a median of six antiepileptic drugs (AEDs) and were currently taking a median of three AEDs.
Differences in drop seizure reduction between CBD and placebo started to show during the titration period and became nominally significant by day 6 (p=0.008) for pooled CBD treatment groups. Meanwhile, the difference between the treatment groups in ≥50-percent responder rate emerged by day 6.
The first reported AE occurred during the titration period in 45 percent of patients (CBD10, 46 percent; CBD20, 52 percent; placebo, 38 percent). The events resolved within 4 weeks of onset in 53 percent of placebo-treated and 39-percent of CBD-treated patients, and by end of study in 63 percent and 61 percent, respectively.