Phase 3 Study Evaluating Clemizole HCl as Additional Treatment for Lennox-Gastaut Syndrome in Children and Adults Ages 2 to 55

What this Trial Is About

Researchers are evaluating clemizole HCl as an additional treatment for children and adults aged 2 to 55 years who have Lennox-Gastaut syndrome LGS, a condition characterized by seizures and abnormal brain activity. This Phase 3 trial aims to assess how well clemizole HCl works and how safe it is when added to existing treatments. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will go through three main phases an Observational Period, a Double-Blind Period, and an optional Open-Label Extension. During the Double-Blind Period, participants receive either clemizole HCl or a placebo as an oral solution. Those who complete this phase may continue to receive clemizole HCl for up to three years in the Open-Label Extension Phase. Throughout the study, participants will be monitored closely with various assessments, including measuring seizure frequency using the CMMS-28 scale over up to 16 weeks. Researchers will also check global impressions of change, quality of life scores, and record any treatment-emergent side effects. The studys overall duration may last up to several years, allowing for long-term safety and effectiveness monitoring.

An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome