Badanie skuteczności i bezpieczeństwa basimglurantu u dzieci, młodzieży i młodych dorosłych z kompleksem stwardnienia guzowatego

Tuberous Sclerosis Complex (TSC) is a genetic disorder that causes non-cancerous tumors to grow in different parts of the body, including the brain. This condition often leads to seizures, which can be difficult to control with standard treatments. The study focuses on evaluating the effectiveness and safety of a medication called basimglurant when used alongside existing anticonvulsive therapies in children, adolescents, and young adults with TSC. Basimglurant is taken in the form of a capsule and is being tested to see if it can help reduce the frequency of seizures in these patients.

The study is designed to compare the effects of basimglurant with a placebo, which looks like the medication but does not contain the active ingredient. Participants will receive either basimglurant or the placebo in addition to their current seizure medications. The study will last for a total of 30 weeks, followed by an additional 52-week period where all participants will have the opportunity to receive basimglurant. The main goal is to determine if basimglurant can effectively reduce the number of seizures and improve the quality of life for those with TSC.

Throughout the study, participants will be monitored for any changes in their seizure patterns and overall health. This includes regular check-ups and assessments to ensure the safety and effectiveness of the treatment. The study aims to provide valuable information on whether basimglurant can be a beneficial addition to the treatment options for individuals with Tuberous Sclerosis Complex.