A Phase 3b/4, Interventional, Multicenter, Open-Label, Single-Arm Study to Assess Behavioral and Other Co-occurring Outcomes Following Treatment With EPID(I/Y)OLEX as Add-on Therapy in Participants (Aged 1 to 65 Years Old) With Seizures Associated With Tuberous Sclerosis Complex (EpiCom)

This study, sometimes called EpiCom, is looking into a medicine named Epidyolex. It's for children and young people between 1 and 65 years old who have seizures because of a condition called Tuberous Sclerosis Complex (TSC). The main goal is to see if taking Epidyolex, alongside their usual seizure medicines, can help with behaviour problems and other challenges that often come with TSC, such as difficulties with sleep, attention, or social interactions.

Researchers will observe participants over a full year to track how their behaviour changes, especially looking at the most troublesome behaviours they experience. They will also collect information on other aspects of life, like how well they sleep, their general mood, and their overall quality of life. This helps paint a complete picture of the medicine's effects.

The study is exploring both how effective Epidyolex is and how safe it is to use. This kind of research is important because it helps doctors and patients understand more about how different treatments can improve the lives of people with TSC. By gathering detailed information from many participants, the study aims to provide valuable insights for the wider medical community.