Trial Number

243-22

Condition

Seizure Disorder

Participant Age Range

2 years to 17 years

Participant Gender

Any

Enrolling Participants

Yes

Overview

A Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated with Epidiolex (Cannabidiol) Oral Solution

Epidiolex has been approved by the United States Food & Drug Administration (FDA) based on studies that showed Epidiolex was effective in reducing the frequency of drop seizures, convulsion seizures and Tuberous Sclerosis Complex (TSC)-associated seizures. Some medications may have an effect on the liver, including medications used for the treatment of seizures.  Even though no cases of serious liver injury was observed in the previous studies of Epidiolex, the FDA has requested that patients prescribed Epidiolex be monitored for changes to the liver with long-term use. Monitoring of the subject's liver is routine care for anyone prescribed Epidiolex.  In this study, the patient will be asked to visit the Study Doctor on a routine basis to test for changes in his/her liver based on blood tests, imaging of the liver and other examinations.

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