A Phase 2B, Multicenter, 30-week, Prospective, Cross-over, Double-blind, Randomized, Placebo-controlled Study Followed by a 52-Week Open-label Extension Study to Evaluate the Efficacy and Safety of Basimglurant Adjunctive to Ongoing Anticonvulsive Therapy in Children, Adolescents, and Young Adults with Seizures Associated with Tuberous Sclerosis Complex

To join this study, people need to be at least 18 years old. There's no upper age limit, meaning adults of any age can potentially take part.

The study is open to both males and females. The most important condition for joining is that participants have seizures that are caused by Tuberous Sclerosis Complex (TSC).

Other specific health requirements or conditions might also apply, such as what other medications they are currently taking or their overall health. These details would be discussed fully with a healthcare professional to see if the study is a good fit.

If you decide to take part in this study, you will essentially be helping researchers understand a new medicine. The study has two main parts: a core part lasting about 30 weeks, and then a longer follow-up period of 52 weeks.

During the core part, you would receive either the study medicine (Basimglurant) or a placebo (a dummy pill that looks the same). You and your doctor won't know which one you're getting at first. Your usual seizure medication will continue as normal. You'll need to keep a careful record of your seizures. There will be regular visits to the clinic, where doctors will check your health, do some tests, and ask questions about how you're feeling and how your seizures are controlled. They will also look at things like your vital signs (blood pressure, heart rate), perform physical examinations, and take blood for lab tests. After the initial 30 weeks, all participants will receive the active study medicine for the additional 52 weeks, with ongoing monitoring.

Throughout the study, doctors will be checking various things such as changes in how many seizures you have, how the medicine affects your daily life, and any side effects. You'll also be asked about your mood and any thoughts you might have. You'll need to take the study medicine as directed. The total duration of active participation receiving either the study medicine or placebo, and then the open-label medicine, will be around 82 weeks, including follow-up assessments.