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The efficacy and safety profile of EPIDIOLEX was established in the largest placebo-controlled, clinical study program in Dravet and LGS completed to date. It included patients whose seizures were uncontrolled despite multiple seizure medicines, defining them as highly treatment resistant.
Those participating in the studies had typically failed 4 to 6 prior seizure medicines. These patients were also taking 3 seizure medicines at the time, but their seizures were still uncontrolled.
Clinical studies included 3 separate phases:
Before starting therapy, patients were assessed and also recorded their daily seizures and other information
At the start of therapy, doses were increased gradually to target dose
For the rest of the study, doses were kept the same to measure how well the medicine works over time