Kehl

Researchers are evaluating a medical device called mjn-SERAS designed to detect and predict epileptic seizures early in individuals aged 12 to 65 with drug-resistant epilepsy. This prospective, multicenter, randomized controlled study will take place in Spain, Germany, and the UK. The goal is to determine how the device impacts patients' quality of life by providing pre-seizure alerts at least one minute before seizures occur, helping reduce anxiety and improve safety. Participants will use the mjn-SERAS device, a wearable, non-invasive EEG recorder fitted as a customized earpiece, along with a mobile app that uses artificial intelligence to generate seizure risk alerts. The study includes a baseline period for data collection, an intervention phase for algorithm training with real seizures, and a six-month period where seizure alerts are active. A control group will be randomized to compare outcomes with those using the device. Throughout the study, patients will report seizures using the app, which also records seizure characteristics and accidents. Researchers will assess quality of life using multiple questionnaires at the start and end of the study. They will also monitor seizure frequency, device accuracy, and safety related to seizure-related accidents over six months. The study aims to improve patient autonomy, reduce injury risk, and enhance overall health by managing epilepsy more effectively in daily life.

Researchers are evaluating the impact of cenobamate, a treatment used alongside other therapies, on healthcare resource use in adults with epilepsy who have uncontrolled focal-onset seizures despite previous treatments. This retrospective observational study aims to compare healthcare utilization before and after starting cenobamate treatment. The study includes data from 200 patients gathered from 10 sites across 5 countries. The study collects medical chart data to analyze healthcare resource use related to epilepsy over a 12-month period following the start of cenobamate treatment. Participants must have had at least six months of medical records before and twelve months after beginning cenobamate, with data gaps no longer than six months. No new interventions are administered during the study as it relies on past medical records. Participants' data will be reviewed to assess healthcare resource use related to epilepsy, focusing on differences before and after cenobamate treatment. Researchers will monitor treatment impact over 12 months, considering early and later treatment lines. The study includes patients aged 18 and older who have had at least one seizure per month in the six months before starting cenobamate. Consent for data processing is required for inclusion.

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.