A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus

Date Added
February 23rd, 2021
PRO Number
Pro00107718
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

This is a research study to evaluate a medication for the treatment of status epilepticus. Status epilepticus is a condition when a patient has continuous seizure activity which usually causes them to be unconscous, be very confused and sometimes to have abnormal body movements. Sometime status epilepticus will not stop after treatment with medications which are currently used by doctors. New medications to stop status epilepticus are needed. This is a study of a medication called ganalaxone which would be administered intravenously to patients with status epilepticus after two typical medications have been tried and not worked. This is a placebo controlled study, meaning that some of the patients will be randomly selected to receive the study medication and some will be selected to receive the placebo medication (which in this case is just salt water given intravenously). Patients in the study will be monitored using continuous electroencephalography (EEG) monitoring and physical exams to determine if the status epilepticus stops. Patients will be called several weeks after treatment to see how well they are doing.

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

A 57-WEEK, MULTICENTER, ACTIVE-TREATMENT, OPEN-LABEL EXTENSION TRIAL OF CVL-865 AS ADJUNCTIVE THERAPY IN ADULTS WITH DRUG-RESISTANT FOCAL ONSET SEIZURES

Date Added
February 9th, 2021
PRO Number
Pro00106750
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

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.

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

Localizing Epileptic Networks using 3T MRI

Date Added
September 29th, 2020
PRO Number
Pro00102615
Researcher
Leonardo Bonilha

List of Studies


Keywords
Epilepsy
Summary

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.

Institution
MUSC
Recruitment Contact
Lindsey Weissman
843-792-2330
weissmal@musc.edu

Clinical and laboratory studies to determine the causes of neurological disease in adults and children

Date Added
September 15th, 2020
PRO Number
Pro00102718
Researcher
Catherine Ziats

List of Studies

Keywords
Alzheimers, Autism, Dementia, Epilepsy, Mental Health, Multiple Sclerosis, Parkinsons
Summary

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.

Institution
Self Regional
Recruitment Contact
Catherine Ziats
8642507944
cziats@ggc.org

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)

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

List of Studies


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)

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

List of Studies


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



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