This 57-week, active-treatment, open-label (all participants will receive study drug throughout the study) extension trial ( enrolls participants of a previous clinical trial into another study) in which all participants gets the study drug is designed to assess the safety and tolerability of CVL-865 as adjunctive treatment (another treatment used together with the primary treatment) in subjects with drug-resistant focal onset seizures. This trial is open to subjects who completed treatment with the investigational medicinal product (IMP) in the double-blind (neither the participant or researchers know what study drug they are receiving) Phase 2 Trial CVL-865-SZ-001 and who, in the opinion of the investigator, could potentially benefit from treatment with CVL-865. There are 17 visits for a duration of 57 active-treatment weeks. The visits are approximately one month apart.
The purpose of this study is to find out if a drug called CVL-865 is safe and effective in the treatment for focal onset epilepsy. The study has an 8-week screening period, followed by a treatment period where adults 18 - 75 years of age that qualify for treatment will be randomly assigned to 3 different dose levels of the study drug. This is followed by a 4-week safety follow up period. The study will last approximately 25 weeks with approximately 7 research related clinic appointments. Participants that successfully complete the treatment period will also have the option of participating in a separate open-label extension study and all participants will be taking the study drug.
This project proposes to develop a system to analyze electroencephalography (EEG) and magnetic resonance imaging (MRI) data from clinical studies of patients with epileptic seizures. This will be called the Next-Generative Neural Data Analysis (NGNDA) platform. This system will use new high-performance computing tools and algorithms to analyze high-dimensional brain data from EEG and MRI. The plan is to create tools for analyzing these big data clinical studies that clinicians can use to improve the care of patients with epilepsy.