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 research study is to study the capabilities of new methods for studying the brain using Magnetic Resonance Imaging (MRI). MRI already provides detailed images of brain anatomy, but newer methods including new MRI techniques and magnetic resonance spectroscopy expand this capability. These new MRI methods will not require any invasive procedures. If successful, these new methods will expand the information, which can be obtained from MRI studies of the brain in patients with epilepsy.
Neurological diseases are the leading cause of disability worldwide and a major contributor to health problems in children and adults. As the majority of these conditions result in lifelong disabilities, the implications for the family and for society is significant.
A significant number of adult and childhood neurological diseases have a genetic component and are caused by changes in our DNA and/or RNA leading to functional changes in the central nervous system. However, for many patients afflicted with these disorders, traditional genetic testing does not identify a clear genetic cause. The goal of this study will be to use newer genetic techniques to evaluate patients and families with neurological disorders to better understand the genetic basis of the disease.
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.
The aim of this multi-site study is to evaluate the effectiveness of mHealth intervention strategies for improving anti-epileptic drug adherence in caregivers of young children with epilepsy. A 2-month baseline period will be followed by two stages. In Stage 1 (3-months), caregivers will received either 1) a mHealth education module and automated digital reminders or 2) the mHealth education module, automated digital reminders, and individualized adherence feedback based. In Stage 2 (2-months), caregivers will either receive 1) continued individualized adherence feedback or 2) individualized adherence feedback and a mHealth problem-solving module. The primary outcome is electronically-monitored adherence. Secondary outcomes include seizure severity/frequency, quality of life and healthcare utilization.
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.