Results from the first randomized, double blind, placebo controlled trial of CBD for Dravet syndrome has been released and shows that CBD can help alleviate seizures for those diagnosed with this syndrome. Dravet syndrome is a rare, lifelong form of epilepsy that beings in infancy with frequent and/or prolonged seizures. Dravet syndrome affects 1 in 15,700 individuals, severely impacting the quality of life and requiring the individual to be under constant care. Current treatment options are extremely limited.
"A total of 108 patients successfully completed the 14-week treatment period that included “randomization” (50% entered the placebo group and 50% entered the cannabidiol group), a 2-week titration up to the desired dose, and a 12 week maintenance period. After this blind portion of the study, patients were offered the option of entering into a long-term open-label study, in which all patients received cannabidiol. In clinical trials, “endpoints” are established during trial design to prevent post-experimental justification or misdirected conclusions from occurring. Primary endpoints measure the most important outcome of the trial, and if a primary endpoint is not met, the trial is usually considered a failure. In this trial, the primary endpoint was the percentage change per 28 days from the 4-week baseline period in convulsive seizure frequency during the 14-week treatment period compared to placebo. In the cannabidiol group, median convulsive seizure frequency (the primary endpoint) decreased from 12.4 seizures per month during baseline to 5.9 seizures per month during treatment (-39%), compared to the placebo group whose median convulsive seizure frequency decreased from 14.9 seizures per month during baseline to 14.1 seizures per month during treatment (-13%).
The secondary endpoints included caregiver impression of change (as measured by a repeated questionnaire with seven options of improvement, worsening, or no change), reduction of convulsive seizure frequency, reduction in total seizure frequency, duration of seizures, sleep disruption (measured on a 10 point scale), sleepiness (measured on 24 point scale), quality of life (measured in a standard questionnaire with a range of 0-100), the Vineland Adaptive Behavior Scale, number of hospitalizations due to epilepsy, new seizure types, and rescue medication use. The secondary endpoints had varying results. 43% of the cannabidiol group experienced a 50% reduction in convulsive seizures compared to 27% of the placebo group. There was little to no difference between the two groups in terms of nonconvulsive seizures, rescue medication use, sleep disruption or sleepiness scores, quality of life scores, or Vineland-II scores, but 62% of caregivers rated their child’s overall condition improved in the cannabidiol group compared to 34% in the placebo group." - Dravet Foundation (https://www.dravetfoundation.org/trial-cannabidiol-drug-resistant-seizures-dravet-syndrome/)
There were adverse effects reported, most commonly being decreased appetite, diarrhea, and fatigue. These effects were reduced by the adjustment of dosage and can also be linked to the use of other medications during the trial.