Clinical trial simulations of the interaction in between cannabidiol and clobazam and impact on drop-seizure frequency.

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With this study we aim to test the hypothesis that the impact of cannabidiol on drop-seizure frequency in individuals with Lennox-Gastaut syndrome and Dravet syndrome could be attributed to a drug-drug interaction with clobazam. We performed clinical trial simulations for the impact of 20 mg/kg/day cannabidiol on drop-seizure frequency in individuals with Lennox-Gastaut syndrome. We assumed that individuals taking 10 or 20 mg clobazam would have a two- to 7-fold boost in N-desmethylclobazam exposure, whereas individuals not taking clobazam would have a median reduction in drop-seizure frequency and a variability in the % reduction equivalent to the placebo group. The final results show that the impact of cannabidiol on the median reduction in drop-seizure frequency in individuals with Lennox-Gastaut syndrome may possibly be explained by a drug-drug interaction with clobazam. This may possibly have crucial implications for the use of cannabidiol and its FDA registration.

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