Kehl

Researchers are evaluating the effectiveness of a single dose of Staccato alprazolam compared with a placebo to quickly stop prolonged seizure episodes in people aged 12 years and older with stereotypical prolonged seizures. The study aims to determine if the treatment can stop seizures within 90 seconds and prevent recurrence for up to 2 hours after administration. This is a phase 3, randomized, double-blind clinical trial sponsored by UCB Biopharma SRL. Participants are randomly assigned to receive one dose of either Staccato alprazolam or placebo by inhalation during the treatment period. The study involves a parallel-group design with one treatment administration. Participants are observed for the treatments effect on seizure cessation and recurrence for up to 6 hours. During the study, participants and their caregivers will be monitored for seizure activity and safety outcomes. Various assessments include measuring treatment success within 90 seconds and seizure recurrence at 2, 4, and 6 hours after treatment. Safety is tracked through adverse event monitoring, with follow-up extending to 19 weeks after treatment. The total participation duration is based on these assessments and monitoring periods.

This research aims to evaluate a medical device called mjn-SERAS in people aged 12 to 65 years with drug-resistant epilepsy. The study is conducted across multiple centers and countries, including Spain, Germany, and the UK. It focuses on assessing the devices impact on quality of life by detecting epileptic seizures early and providing alerts before seizures occur, helping to improve patient safety and reduce anxiety linked to seizure unpredictability. The intervention involves using the mjn-SERAS device, a wearable, non-invasive EEG recorder paired with a smartphone application. The study includes three phases a baseline phase for initial assessments over two months, an intervention phase with artificial intelligence training lasting 4 to 10 weeks, followed by at least six months of active seizure risk alert monitoring, and a results phase comparing outcomes with baseline data. Participants wear a customized earpiece for EEG recording and use the app to report seizures and receive alerts. Participants will be involved for at least six months, during which their seizure occurrences, types, and related accidents will be monitored and recorded. Various questionnaires will assess quality of life, anxiety, depression, and social functioning. The devices accuracy and safety will also be evaluated. Data are collected through seizure diaries, app reports, and clinical evaluations to understand the devices effect on health resources, mental well-being, and patient safety over time.

Researchers are evaluating how the drug cenobamate affects healthcare resource use for adults with epilepsy who have uncontrolled focal onset seizures. This observational, retrospective study compares medical resource use before and after patients start cenobamate as an additional therapy because previous anti-seizure medications were not effective or tolerable. Data from medical charts of 200 patients across 10 sites in 5 countries will be collected and analyzed. The study focuses on adult patients who began treatment with cenobamate as adjunctive therapy according to approved guidelines. Patients included have uncontrolled focal seizures despite 2 to 5 prior anti-seizure medications and have at least 6 months of data before starting cenobamate and 12 months of data afterward. This retrospective chart review gathers real-world data without altering patient treatment. Participants medical records will be reviewed for healthcare resource use related to epilepsy, including hospital visits, emergency care, medication use, surgeries, and phone or virtual contacts over a 12-month period before and after starting cenobamate. Researchers will also assess safety data and how concomitant anti-seizure medications change. The study is conducted under data protection regulations and will provide insights into the impact of cenobamate on managing uncontrolled focal seizures.