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.
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.
A seizure is a common sign or symptom characterized by abnormal electrical activity in the brain that affects about 10% of individuals in the population at some point in their lives. Although most are self-limited and transient, seizures sometimes fail to respond to medications and may even progress despite administration of medications. When these seizures are characterized by spread to both sides of the brain (become generalized), aggressive management with sedating medications is warranted. However, if seizures remain confined to one side of the brain (remain focal), the risks associated with high doses of sedating medications often outweighs the potential benefits of stopping the seizure. This has led to a search for other therapies that can more effectively target and control focal seizures without causing significant sedation, damage to other organs, or medication interactions. Transcranial magnetic stimulation (TMS) is one such therapy that has shown promise in case series and case reports, although no clinical controlled trial has yet been published to validate its efficacy in patients with severe seizures. In addition, TMS has been shown to be safe for use in epilepsy and other disorders.
We aim to evaluate the efficacy of TMS in patients with severe seizures that are not controlled with medications.
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.
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 24 months.
The purpose of the study is to find out if SAGE-547 has any effect on continuous seizures and if it is safe to use in subjects in super-refractory status epilepticus (SRSE). Subjects in SRSE have continuous seizures that will not stop even after they have been given seizure medications that are expected to cause the seizures to stop. Subjects in SRSE are given anesthetic medications that make them unconscious in order to control the seizures. This is thought to help lessen the damage to the brain caused by the seizures and to reset the brain to try to stop the seizures.
If the subject continues to have continuous seizures during the 24 hours following the end of the initial treatment period, the subject may be eligible to receive the active study drug (SAGE-547) during the retreatment period. The study doctor will determine if the subject is eligible for the retreatment period, and the decision to retreat the subject will be discussed with you. The retreatment period is open-label, meaning the study doctor, the subject, and you will know that SAGE-547 (active substance) will be given. The length of the retreatment period will be identical to the initial treatment. Subjects who are eligible for the retreatment period will have more visits and be in the study longer than subjects who only receive the initial treatment.
As a part of this study, information will be collected on how much allopregnanolone (the active ingredient in SAGE-547) is present in the subject?s blood during the study, and whether SAGE-547 affects the subject?s level of consciousness/drowsiness, mental ability, overall condition, outcome and improvement.
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.
The goal of this study is to determine the effectiveness of the Companion™ device to detect GTC seizures and alert someone to the seizure.
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.
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.