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Clinical Trial Summary

The study intends to show that basimglurant provides effective seizure control in children and adolescents with Tuberous Sclerosis Complex (TSC).

Clinical Trial Description

The study drug (basimglurant) is a potent inhibitor of metabotropic glutamate receptor 5 (mGluR5) which controls a wide range of processes in the brain, spinal cord, retina, and peripheral nervous system. In animal studies, the inhibition of this receptor has shown therapeutic potential for the treatment of Tuberous Sclerosis Complex (TSC). This receptor's inhibition decreases the frequency of seizures. In previous clinical trials, the study drug has shown an advantageous safety profile in children and adolescents. The objective of this study is to find an optimal dose at which the study drug will lead to a decrease in the duration, frequency and intensity of seizures in children and adolescents with TSC, while being well tolerated. All patients who positively respond and tolerate the medicine will be offered the possibility to continue in an open label extension. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05059327
Study type Interventional
Source Noema Pharma AG
Status Not yet recruiting
Phase Phase 2
Start date November 22, 2021
Completion date May 1, 2023

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