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Researchers are evaluating carisbamate (YKP509) as an additional treatment to reduce drop seizures in children and adults aged 4 to 55 years diagnosed with Lennox Gastaut Syndrome (LGS), a condition characterized by multiple seizure types and developmental delay. This Phase 3 study aims to compare carisbamate to placebo, focusing primarily on its effect in lowering tonic, atonic, and tonic-clonic seizures that can cause falls. Secondary goals include assessing overall seizure reduction, safety, tolerability, and the drug's steady-state pharmacokinetics in this population. Participants will receive carisbamate in doses adjusted by age and weight: adolescents 12 to 18 years receive the adult dose, while children 4 to under 12 years receive either 4 mg/kg or 5.5 mg/kg twice daily depending on the assigned dose group, with maximum limits of 200 mg or 300 mg twice daily respectively. The study includes a double-blind treatment period comparing carisbamate and placebo, with an optional open-label extension phase for further evaluation. Throughout the study, participants and their caregivers will keep seizure diaries to track seizure frequency, especially drop seizures. Researchers will monitor seizure counts, safety, and tolerability over three years, with the primary outcome being the percentage change from baseline in drop seizures during the double-blind period. Participants must comply with stable background anti-seizure medications and dietary or device therapies, and assessments include EEG history and ongoing clinical evaluations to ensure safety and measure treatment effects.

Age: 4Years - 55YearsAll GendersPhase 3
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