A clinical trial has employed cannabidiol, one of the components of the plant cannabis, to treat a type of childhood epilepsy rare, serious and difficult to treat and has shown a decrease in seizures in those affected and an improvement in their quality of life.
He La Fe Hospital in Valencia participate in this phase 3 study of cannabidiol in patients with Lennox-Gastaut syndrome (LGS), whose results have been published in the journal The New England Journal of Medicine (NEJM).
The neurologist Vicente Villanueva, Head of the Refractory Epilepsy Unit at the La Fe University and Polytechnic Hospital, is co-author of the work, both with the inclusion of patients and with the analysis of data, reported sources from the hospital.
According to Villanueva, the results obtained in this work carried out by the Neurology and Neuropediatrics services of La Fe, demonstrate that cannabidiol "has achieved a improvement in the most severe crises in a significant number of patients." "This, in such a serious disease, in which the existence of drugs that work is scarce, is great news», he stressed.
This trial is the first dose-ranging study comparing a pharmaceutical formulation of cannabidiol with placebo as an add-on therapy in LGS. Both doses significantly reduced the frequency of attacks in patients with poor seizure control, despite the use of multiple antiepileptic drugs.
Children between 3 and 5 years old
The proven cannabidiol (CBD, Epidiolex®) oral solution is a pharmaceutical formulation of highly purified cannabinoid (CBD), a cannabinoid that lacks the effects of euphoria that are associated with the dope.
Lennox-Gastaut syndrome appears between 3 and 5 years of age and patients suffer multiple types of seizures, both atonic and tonic, which often cause falls and injuries and absences. In addition, most affected children experience some degree of intellectual impairment, as well as developmental delays and behavioral disorders.
Although the incidence of this disease is difficult to determine, previous epidemiological studies have detected 500 cases in Spain, a figure that, according to Villanueva, could rise to a thousand cases.
According to the expert, although epilepsy treatment has greatly improved and the lives of these patients are prolonged, the problem is that they are "very resistant" to antiepileptic medication, "so there are few options that work." New alternatives open up options for us for treatments.
Recently approved
The study randomly selected 225 patients with LGS and a mean age of 16 years from 30 hospitals in the United States and Europe, four of whom were La Fe patients, and whose seizures were not controlled with their current regimen of antiepileptic drugs. The patients received a dose of cannabidiol oral solution or placebo in addition to their existing treatment.
At baseline, patients had a mean seizure frequency of 85 per month and during the 14-week treatment period experienced significantly greater mean reductions in monthly atonic seizures of 37.2% compared with a reduction of 17.2% for placebo.
As secondary results of the study, the following stand out: overall improvement patients and their quality of life. According to Villanueva, the crises in which the greatest improvement was detected were "the most severe, the most disabling ones, those associated with falls."
The drug has just been recently approved by the US Food and Drug Administration. USA (FDA) and is expected to be available to US patients with LGS and Dravet syndrome (another type of epilepsy) in the second half of the year.
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