Radeberg

Researchers are evaluating the effectiveness of perampanel as an additional treatment for children with pediatric epileptic syndrome and partial-onset seizures. The study focuses on the proportion of participants who experience a 50% reduction in seizure frequency during the maintenance period. This is an open-label Phase 2 study involving pediatric participants aged from 1 month to less than 18 years. The study includes a Core Study and two Extension Phases. The Core Study has a 4-week screening period followed by a 23-week treatment period, split into a 10-week titration phase and a 13-week maintenance phase. Extension Phase A includes a 33-week treatment period and a 4-week follow-up period and is open to those who complete the Core Study. Extension Phase B is for participants from countries without commercial access to perampanel who complete Extension Phase A and may continue to benefit from treatment. Participants receive perampanel either as an oral suspension or tablet as adjunct therapy alongside their current antiepileptic drugs. Participants will attend regular visits for assessments including seizure monitoring and safety evaluations throughout the study and extensions. Researchers will measure the seizure reduction response during the maintenance period and monitor safety and tolerability. The total treatment and follow-up duration can extend beyond the Core Study through the Extension Phases for eligible participants. The study requires stable doses of antiepileptic drugs before enrollment and excludes participants with certain psychiatric, neurological, or treatment histories.

Researchers are investigating the safety, tolerability, and effectiveness of XEN1101 as an additional treatment for people with primary generalized tonic-clonic seizures (PGTCS) who have generalized epilepsy and are already taking 1 to 3 anti-seizure medications. This phase 3, multicenter, randomized, double-blind, placebo-controlled study includes participants aged 12 years and older and aims to better understand how XEN1101 affects seizure frequency compared to placebo. Participants will be randomly assigned to receive either XEN1101 or a placebo capsule once daily with their evening meal during a 12-week double-blind treatment period. Those aged 18 and older will take a 25 mg dose of XEN1101 or placebo, while those aged 12 to under 18 may receive 15 mg, 25 mg, or placebo. Before this period, participants will have up to 9.5 weeks to record their baseline seizure frequency. After completing the double-blind period, participants can join an open-label extension study for continued XEN1101 treatment or enter an 8-week follow-up phase if they do not enroll in the extension. During the study, participants will keep detailed seizure diaries and maintain stable doses of their anti-seizure medications. Researchers will monitor seizure frequency changes, safety, and tolerability throughout the treatment. The main measurement is the median percent change in monthly primary generalized tonic-clonic seizure frequency from baseline through the 12-week treatment. Safety follow-up and monitoring will continue during the post-treatment follow-up or open-label extension periods, with total participation lasting several months depending on extension enrollment.

Researchers are evaluating LP352, a treatment for seizures in children and adults with Developmental and Epileptic Encephalopathies (DEE), including Lennox-Gastaut Syndrome (LGS) and other DEE types. This Phase 3, double-blind, randomized, placebo-controlled study aims to assess the effectiveness, safety, and tolerability of LP352. The study involves participants aged 2 to 65 years who experience multiple types of motor seizures and have a history of developmental plateauing or regression. Participants will receive either LP352 or a matching placebo, administered orally or through a gastrostomy tube if needed. The study includes several phases: Screening, a Titration period to adjust dosing, a Maintenance period to continue treatment, followed by a Taper period to gradually reduce the medication, and a final Follow-Up phase. The entire study will last about 24 months. Throughout the study, participants will be closely monitored for changes in the frequency of their countable motor seizures compared to baseline over up to 15 weeks. Researchers will collect data through seizure diaries maintained by participants or caregivers, clinical assessments, and safety evaluations. The study also tracks adherence to treatment and overall tolerability to better understand the impact of LP352 on seizure control and patient well-being.

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.

Researchers are evaluating the effectiveness of BHV-7000 in treating adults with refractory focal onset epilepsy, a condition where seizures originate in specific areas of the brain and have not responded to previous treatments. This Phase 2/3 trial aims to assess the safety, tolerability, and ability of BHV-7000 to reduce seizure frequency in participants who continue to have seizures despite using anti-seizure medications. The study follows classification criteria set by the International League Against Epilepsy and includes participants aged 18 to 75 years. Participants will be randomly assigned to receive either BHV-7000 at doses of 50 mg or 75 mg once daily, or a matching placebo, in a double-blind setup where neither participants nor researchers know which treatment is given. The treatment period focuses on monitoring changes in seizure frequency over 28-day averages from baseline through weeks 8 to 16. The study design includes careful control and comparison to evaluate the investigational drug's impact. During the study, participants will keep accurate seizure diaries to track their seizures. Researchers will measure changes in the average number of seizures over 28-day periods as the primary outcome. Safety and tolerability will also be monitored closely. The study requires participants to be currently treated with one to three anti-seizure medications and to meet specific epilepsy criteria. Overall participation includes screening, treatment, and follow-up to assess the drug's effects and participant safety.