Radeberg

Researchers are studying the use of XEN1101 as an additional treatment for people aged 12 years and older who have primary generalized tonic-clonic seizures PGTCS associated with generalized epilepsy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the clinical effectiveness, safety, and tolerability of XEN1101 when added to existing anti-seizure medications. Participants are currently taking 1 to 3 anti-seizure medications and have had probable or possible PGTCS for at least one year. Participants will be randomly assigned to receive either XEN1101 or a placebo. Those aged 18 years and older will receive a 25 mg daily dose of XEN1101 or placebo. Participants aged 12 to under 18 years may receive 15 mg, 25 mg, or placebo daily. The study includes a baseline period lasting up to 9.5 weeks to track seizure frequency, followed by a 12-week double-blind treatment period where participants will take the assigned capsules once daily with an evening meal. After completing this period, participants can join an open-label extension study for continued XEN1101 treatment or enter an 8-week post-treatment follow-up if they do not enroll. During the study, participants will keep accurate seizure diaries and attend scheduled visits to monitor their health and response to treatment. Researchers will evaluate changes in monthly seizure frequency as the main outcome. Additional assessments will track safety, tolerability, and other measures throughout the treatment and follow-up periods. Overall participation may last several months, including baseline assessment, treatment, possible extension, and follow-up phases.

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.