The following article is part of coverage from the American Academy of Neurology’s Annual Meeting (AAN 2020). Due to the global COVID-19 pandemic, the Academy made the necessary decision to cancel the meeting originally scheduled for April 25–May 1, 2020, in Toronto. While live events will not proceed as planned, readers can click here catch up on the latest research intended to be presented at the meeting.
Add-on cannabidiol (CBD) was found to be safe and effective for patients with Lennox Gastaut Syndrome (LGS), according to study results intended to be presented at the annual meeting of the American Academy of Neurology (AAN 2020).
Previous studies have suggested that CBD is a safe and effective treatment option for patients with LGS. The goal of the current study was to investigate the long-term profile of add-on CBD in the third analysis of the open label extension (GWPCARE5) of two phase 3, randomized controlled trials (GWPCARE3 and GWPCARE4).
The study cohort included 366 of 368 eligible patients (mean age, 16 years; 54% men; median follow-up, 150 weeks) who completed 1 of the 2 randomized-controlled trials; however, 119 participants withdrew from the study. The participants received plant-derived highly purified CBD (Epidiolex®; 100 mg/mL oral solution).
The primary outcome of the study was the safety of CBD treatment; the secondary outcome was the efficacy, based on median percentage change in drop and total seizure frequency.
Treatment with CBD was associated with median percentage reductions in seizure frequency of 48 to 71% for drop seizures and 48 to 68% for total seizures.
During the extended follow-up, adverse events were documented in 96% of the participants, including serious adverse events in 42% of participants and events that led to discontinuation in 12% of participants. The most common adverse events (≥20%) included diarrhea, convulsion, pyrexia, somnolence, vomiting, upper respiratory tract infection, and decreased appetite.
Although there were 11 deaths during the follow-up period, none were deemed to be treatment-related.
“Long-term treatment with add-on CBD in patients with LGS produced sustained seizure reductions, with no new safety concerns,” concluded the researchers.
Patel A, Chin R, Mitchell W, et al. Long-term safety and efficacy of cannabidiol (CBD) treatment in patients with Lennox-Gastaut Syndrome (LGS): 3-year results of an open-label extension (OLE) trial (GWPCARE5). Intended to be presented at the 2020 annual meeting of the American Academy of Neurology. Abstract S25.004.
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