In a clinical trial led at Great Ormond Street Hopsital (GOSH) by Professor Helen Cross, cannabidiol cut the number of drop attacks – a type of epileptic seizure causing children to drop suddenly to the floor. LGS typically occurs between ages 3 to 5 years and can be caused by head injuries, nervous system infections and genetic conditions. Children who live with LGS experience debilitating seizures, particularly drop attacks, which can lead to serious injuries, so this drug could make a significant difference to their quality of life.
The study, which was recently published in the New England Journal of Medicine showed that at the end of the 14 week treatment period the average number of drop attacks reduced by around 40% compared to only 17% of patients given a dummy drug or placebo.
This follows on from last year when another multicentre trial led by Professor Cross and also carried out at the National Institute for Health Research (NIHR) GOSH Clinical Research Facility (CRF) found that cannabidiol also reduced seizures in children with another type of complex epilepsy, Dravet syndrome. This evidence was part of a new drug application submission to the US Food and Drugs Administration (FDA) which was accepted in December, and will licence at the end of June. Marketing authorisation was recently submitted to the European Medicines Agency (EMA) and is currently under review. Following the core studies several patients continued on the open label extension study and the named patient supply programme at GOSH CRF and further studies are planned in infantile spasms and epilepsy associated with tuberous sclerosis.
“These studies provide robust evidence of the effectiveness of cannabidiol for children with drug resistant forms of epilepsy and will have significant impact for patients with these serious and debilitating conditions,” said Professor Cross.