A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerablity of TAK-935 as an Adjunctive Therapy in Pediatric Patients with Developmental and/or Epileptic Encephalopathies Save

Date Added
January 22nd, 2019
PRO Number
Pro00083332
Researcher
Jonathan Halford

List of Studies


Profiles_link
Keywords
Epilepsy
Summary

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.

Institution
MUSC
Recruitment Contact
Rebecca Hamrick
843-792-3855
hamrickr@musc.edu

Testing of ZETO EEG Recording Headset in a VA Community Based Outpatient Clinic Save

Date Added
August 21st, 2018
PRO Number
Pro00080373
Researcher
Jonathan Halford

List of Studies


Profiles_link
Keywords
Epilepsy
Summary

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.

Institution
MUSC
Recruitment Contact
Elizabeth Aprile
843-789-7428
elizabeth.aprile@va.gov

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Exploring the Efficacy, Safety, and Tolerability of Natalizumab (BG00002) as Adjunctive Therapy in Adult Subjects With Drug-Resistant Focal Epilepsy Save

Date Added
February 13th, 2018
PRO Number
Pro00072354
Researcher
Jonathan Halford

List of Studies


Profiles_link
Keywords
Epilepsy
Summary

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.

Institution
MUSC
Recruitment Contact
Rebecca Hamrick
843-792-3855
hamrickr@musc.edu

NSF 1649865 EAGER: Next-Generation Neural Data Analysis (NGNDA) Platform: Massive Parallel Analysis of Multi-Modal Brain Networks Save

Date Added
April 18th, 2017
PRO Number
Pro00064530
Researcher
Jonathan Halford

List of Studies


Profiles_link
Keywords
Epilepsy
Summary

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.

Institution
MUSC
Recruitment Contact
Rebecca Hamrick
843-792-3855
hamrickr@musc.edu

High Performance Seizure Monitoring and Alert System ? Phase IIB Save

Date Added
July 21st, 2015
PRO Number
Pro00045896
Researcher
Jonathan Halford

List of Studies


Profiles_link
Keywords
Epilepsy
Summary

The purpose of this project is to develop a highly accurate, reliable, and user-friendly electroencephalogram (EEG) recording and seizure monitoring and alert system (CereScope™) for use during times where patients require close EEG monitoring to detect seizures.

Institution
MUSC
Recruitment Contact
Rebecca Hamrick
843-792-3855
hamrickr@musc.edu

A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures with a Seizure Detection and Warning System in Epilepsy Patients Save

Date Added
March 24th, 2015
IRB Number
20848
Researcher
Jonathan Halford

List of Studies


Profiles_link
Keywords
Epilepsy
Summary

The goal of this study is to determine the effectiveness of the Companion™ device to detect GTC seizures and alert someone to the seizure.

Institution
MUSC
Recruitment Contact
Becky Hamrick
(843) 792-3855
hamrickr@musc.edu

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