The primary objective of this study is to investigate the effect on the frequency of all seizures in pediatric patients with developmental and/or epileptic encephalopathies treated with TAK-935 as adjunctive therapy compared to placebo, as well as evaluate the safety and tolerability of the study drug.
Study TAK-935-2002 includes pediatric patients (aged 2- 17 years) with Dravet syndrome experiencing convulsive seizures and and Lennox Gastaut syndrome experiencing drop seizures. The study cosists of 2 main periods: a 4-6 week screeing/baseline period followed by a 14 week treatment period. The treatment period consists of a 2 week titration period followed by a 12 week maintenance period. There will be approximately 6 clinic visits and 2 phone visits over 10 months.
The study PI and ZETO staff will train a nurse at the Charleston VA to acquire EEGs using the ZETO dry electrode EEG system at a Community Based Outpatient Clinic (CBOC) in South Carolina. The location of the CBOC will probably be in Beaufort, SC, where a previous similar study was performed. This ZETO device is easy to use and can be set up in 5-10 minutes because it is a headset which is placed on the head without skin or hair preparation. A total of 20 Veterans who are scheduled to be seen for primary care appointments at a VA CBOC will be recruited. Each EEG recording will take about 30 minutes to complete (including set-up time). EEG setup time and patient comfort measures will be acquired. EEG signal will be analyzed for signal quality with assistance from an investigator at the School of Computing at Clemson University. Three neurologist co-investigators will also assist in analysis of the EEG recordings.
This in an exploratory study and the information obtained may lead to new findings regarding the treatment of seizures in adults with drug-resistant focal epilepsy. This study will explore the effectiveness, safety, and of a medication called natalizumab.
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.
The goal of this study is to determine the effectiveness of the Companion™ device to detect GTC seizures and alert someone to the seizure.