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Basimglurant in Children, Adolescents, and Young Adults With TSC

Tuberous Sclerosis Complex Clinical Trial

Official title:
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 Uncontrolled Seizures Associated With Tuberous Sclerosis Complex

Clinical Trial Summary

The study intends to show that basimglurant provides effective seizure control in children, adolescents and young adults 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, adolescents and young adults 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

Clinical Trial Details
NCT number NCT05059327
Study type Interventional
Source Noema Pharma AG
Contact Noema Pharma
Phone Please contact via email:
Email clinicaltrials@noemapharma.com
Status Recruiting
Phase Phase 2
Start date March 3, 2022
Completion date January 31, 2026
View Details
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