Study of Carisbamate as an Additional Treatment to Reduce Seizures in Children and Adults with Lennox-Gastaut Syndrome

What this Trial Is About

Researchers are studying the use of carisbamate YKP509 as an additional treatment to reduce drop seizures in children and adults aged 4 to 55 years with Lennox Gastaut Syndrome LGS. This trial aims to compare carisbamate to a placebo in lowering the number of tonic, atonic, and tonic-clonic seizures. Secondary goals include assessing the overall seizure reduction, safety, tolerability, and how the drug behaves in the body. Participants receive carisbamate or placebo twice daily with doses adjusted based on age and weight. Children aged 4 to under 12 years receive weight-based dosing, while those 12 years and older follow fixed dosing schedules. The study includes a titration period to reach maintenance doses. Some participants may join an optional open-label extension. The study is randomized and double-blind, meaning neither participants nor researchers know who receives carisbamate or placebo. During the trial, participants and caregivers will track seizures using diaries. Regular assessments will measure seizure frequency changes over time, including the primary outcome of percentage change in drop seizures during the double-blind period lasting up to three years. Researchers will also evaluate global impressions of change and monitor safety through clinical evaluations. The total study duration includes baseline, treatment, and follow-up periods, ensuring thorough monitoring of effects and safety.

Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults