A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation Study With an Open-Label Phase to Examine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-935 as an Adjunctive Therapy in Subjects With Developmental and/or Epileptic Encephalopathies Save

Date Added
June 27th, 2017
PRO Number
Pro00066787
Researcher
Jonathan Halford

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Keywords
Epilepsy
Summary

The purpose of this study is to characterize the multiple-dose safety and tolerability profile of TAK-935 in adult subjects with developmental and/or epileptic encephalopathies. This is a phase 2 multi-center, randomized, double-blind, placebo-controlled, dose-escalation study with an short open-label phase. The goal is to do some dose ranging and assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Additionally, subjects will have screening for a genetic marker of risk for antiepileptic-drug hypersensitivity syndrome.

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

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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

An Open Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects with Partial Onset Seizures Save

Date Added
December 13th, 2016
PRO Number
Pro00061843
Researcher
Jonathan Halford

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Keywords
Epilepsy
Summary

This research study is designed to evaluate the safety of YKP3089 and to
further evaluate how YKP3089 and other anti-epileptic drugs (AEDs) affect each other in the body when given together. The study will also evaluate long term safety of YKP3089 as adjunctive therapy in partial onset seizures.

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

An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes Save

Date Added
December 1st, 2015
PRO Number
Pro00049665
Researcher
Jonathan Halford

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Keywords
Epilepsy
Summary

The purpose of this study is to find out if the study medication, GWP42003-P (also known as cannabidiol, CBD), can help control seizures and is safe in children and adults with Dravet or Lennox-Gastaut syndrome (LGS). GWP42003-P is an investigational medicinal product.

The active study medicine is cannabidiol (CBD), known as GWP42003-P. It is extracted from cannabis plants (marijuana) under highly controlled conditions to ensure the product is always the same.

Participants must have previously participated in the core studies and participation is expected to last 36 months.

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

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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

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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

A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome Save

Date Added
March 24th, 2015
PRO Number
Pro00038643
Researcher
Jonathan Halford

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Keywords
Epilepsy
Summary

The purpose of this study is to find out if the study medication, GWP42003-P (also known as cannabidiol, CBD), can help control seizures and is safe in children and young adults with Dravet syndrome. We will be comparing the GWP42003-P medicine with a dummy medicine (placebo) that looks, smells, and tastes just like GWP42003-P, but does not have any active ingredient.

GWP42003-P is an investigational product. This means it has not been approved by the Food & Drug Administration for the treatment of epileptic seizures in people with Dravet syndrome.

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

Human Epilepsy Project Save

Date Added
June 18th, 2013
PRO Number
Pro00024605
Researcher
Jonathan Halford

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Keywords
Central Nervous System, Epilepsy
Summary

Epilepsy affects more than 1% of the population. About 1/3 of people with epilepsy will be unable to control their seizures successfully. Among the 2/3 that do achieve seizure control, many will have tried multiple medications over many years, with varying side effects. The goal of this study is to use easily available information such as common diagnostic tests (MRI, EEG, blood samples) to learn how to identify early-on which people are likely to have side effects from treatments, as well as difficult-to-control epilepsy. By gaining this knowledge, we hope to get people the appropriate treatments more promptly, and reduce the number of side effects they experience on their way to seizure control.

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

Measurement of Automated EEG Artifact Removal Performance Using Evoked Potentials Save

Date Added
April 16th, 2013
PRO Number
Pro00023968
Researcher
Jonathan Halford

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Keywords
Epilepsy
Summary

EEG is the most common neurophysiology procedure. Unfortunately, EEG is plagued with the problem of artifacts. Artifacts are contaminant signals which come from other sources than the brain. These other sources are electrical potentials from eye movement, electromyogram (EMG) signals from muscles of the scalp, 60 Hz noise from the electrical power system, signals caused by patient movement, and noise from problems with individual EEG electrodes. The purpose of this study is to create EEG recordings from normal subjects that can be used to measure how well automatic EEG artifact removal software works. EEG recordings will be made from subjects during two states: (1) while subjects are at rest and (2) while subjects are being given somatosensory, visual, and auditory stimuli. The stimuli that will be used will be standard clinical somatosensory evoked potential stimuli using electrical shocks to the left wrist, flashing lights for a visual stimulus, and audio click sounds throughout headphones for the auditory stimuli. The averaged evoked potentials will be studied before and after automatic EEG artifact removal software is applied and comparied between the resting state and the stimulated state.

Institution
MUSC
Recruitment Contact
Kimberly Schnabel
843-792-3855
schnabel@musc.edu

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