A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Trial of CVL-865 as Adjunctive Therapy in Adults with Drug-Resistant Focal Onset Seizures (REALIZE Trial) Save

Date Added
March 10th, 2020
PRO Number
Pro00096604
Researcher
Jonathan Halford

List of Studies


Profiles_link
Keywords
Epilepsy
Summary

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.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
843-792-1115
Bulgarino@musc.edu

eACT (epilepsy: Adherence in children and technology) Save

Date Added
May 4th, 2019
PRO Number
Pro00087259
Researcher
Janelle Wagner

List of Studies

Silhouette
Keywords
Children's Health, Epilepsy, Pediatrics
Summary

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.

Institution
MUSC
Recruitment Contact
Millie Griffin
843-792-4653
grifm@musc.edu

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy, with an Open-Label Extension Save

Date Added
March 26th, 2019
PRO Number
Pro00085211
Researcher
Ekrem Kutluay

List of Studies


Profiles_link
Keywords
Epilepsy
Summary

This study is to evaluate how safe the study drug XEN1101 is for patients with focal epilepsy when it is taken with the patients standard epileptic medications.

This investigational drug has been tested in healthy volunteers but this is the first time it will be tested in participants with focal-onset epilepsy. The study consists of 3 phases;a screening /baseline phase lasting 4 weeks to confirm participants qualify to enroll in the study, a treatment phase in which participants may or may not receive study drug lasting 8 weeks with 6 study visit appointment visits, and an optional extension phase in which participants will receive study drug for a year with 6 study visits appointments.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
843-792-1115
Bulgarino@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

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