Active clinical trials for "Epilepsy"

Study is the first study after commercialization of brivaracetam. It is designed to collect real world information on the effectiveness of brivaracetam in patients with Partial Onset Seizure epislepsy who are treated in standard clinical practice.

The major hypothesis explaining drug resistance is overexpression of p-glycoprotein at the target lesion. Based on several studies, p-glycoprotein (P-gp) has an important role in neurologic diseases, especially in drug resistant epilepsy. But there is no surrogate marker that can quantify the expression of P-gp because of the difficulty in measuring substances in the neurologic system and the lack of clinical trials. Here, the investigators use a novel non-invasive [11C] -verapamil Brain PET and SPAM analytic method as a surrogate marker for quantifying the expression of p-glycoprotein.

The studies described in this protocol are all performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Workpackage 2 and Workgroup 1. Primary aim of these studies is to develop, test and disseminate methodological standards for the design, conduct and analysis of Pharmacoepidemiological (PE) studies applicable to different safety issues and using different data sources. To achieve this, results from PE studies on five key adverse events (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the methodological aspects of the studies in this protocol and not on the clinical consequences of the association under investigation. In the present project, investigators use Columbia Classification Algorithm of suicide assessment (C-CASA) definitions as a basis to specify the operational definitions of the different aspects of suicidality. The focus of the main analyses is on attempted suicide including completed suicide. This is due to statistical power issues. However, investigators will apply two additional outcome definitions in sensitivity analyses: 1) completed suicide only and 2) completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation plus indeterminate or potentially suicidal events. Investigators will not include terms which clearly indicate an accidental event, or self-injurious behavior without a suicidal intent. These definitions are listed in the statistical analysis plan together with lists of terms from the dictionaries used in the different databases. The objectives of this study are to 1) Compare the study results which are based on two data sources (he UK General Practice Research Database (GPRD) and Danish registries) and different designs and evaluate the impact of design and population differences on the outcome of the study results (the UK database 'The Health Improvement Network' (THIN) may be included in these analyses as well); 2) Evaluate the strengths and weaknesses of the two data sources to study a possible association of antiepileptic drug (AED) use and suicidality, in particular the specific outcomes of death from suicide, hospitalization due to suicide attempt, and reports of the aspects of suicidality by the patients; 3) Estimate risks of completed suicide, completed suicide and attempted suicide, and completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation plus indeterminate or potentially suicidal events overall for all AEDs and by individual AEDs prescribed in UK and Denmark; and 4) Describe the patterns of AED prescribing in six European databases (GPRD and THIN, UK; Danish registries; Mondriaan, Netherlands; Bavaria, Germany; Base de Datos para la Investigación Farmacoepidemiologica en Atencion Primaria (BIFAP), Spain).

Background: The brain is protected by a barrier that keeps toxins in the blood from reaching the brain. However, this barrier can also keep useful medications from reaching the brain. P-glycoprotein (P-gp) is a brain protein that is part of the blood-brain barrier. The level of P-gp is higher in people with epilepsy than in people without epilepsy. These different levels of P-gp may explain why some people have seizures that do not respond well to medications. Researchers want to see if P-gp can affect the response to epilepsy medications. Epilepsy may also be associated with brain inflammation. Researchers also want to look at the part of the brain affected by epilepsy to see if inflammation is present. Objectives: To see if P-gp can affect the response to epilepsy medications. To see if inflammation is present in the part of the brain affected by epilepsy. Eligibility: <TAB>Individuals between 18 and 60 years of age who have temporal lobe epilepsy. We plan to study some patients whose seizures are well controlled by drugs, and some whose seizures are not controlled. <TAB> Healthy volunteers between 18 and 60 years of age. Design: This study requires four or five visits to the NIH Clinical Center over the course of a year. The visits will be outpatient visits and will last from 2 to 5 hours. Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. All participants will have two positron emission tomography (PET) scans. The scans will take place during different visits. Different drugs will be used in each scan. One drug will be used to temporarily block the effect of P-gp in the brain. The other drug will show areas of inflammation in the brain. Participants with epilepsy will have a third PET scan. This scan will also look at P-gp activity in the brain. However, it will not use the drug that blocks the effect of P-gp. All participants will also have one magnetic resonance imaging scan. This scan will help show brain function.

The purpose of this observational registry is to evaluate the long-term effectiveness, safety and performance of market-released Medtronic Neuromodulation products for Deep Brain Stimulation (DBS) for the treatment of refractory epilepsy. In addition, healthcare resource use and patient reported outcomes, such as health related quality of life will be assessed.

This is a multicenter, non-interventional, prospective study. The observation period comprises at least 6 months, from the initiation of ESL add-on therapy in adult patients with partial-onset epilepsy not sufficiently controlled with one AED, until the first visit that occurs between 6 and 9 months of follow-up. The observation period will end after 9 months of follow-up even if the final assessment is not performed.

Validation of qolie-10, an epilepsy specific quality of life questionnaire in patients treated with lamotrigine or valproic acid. Comparison of quality of life of epileptic patients treated with lamotrigine or valproic acid. Determination and assessment of the comparative safety of lamotrigine or valproic acid. Assessment and comparison of body image perception in women treated with lamotrigine or valproic acid.

The purpose of this observational study is to evaluate the safety of topiramate when used in combination with other medications for seizures in adults and children.

This study is designed to test the effects of vigabatrin (gamma-vinyl-GABA) an experimental drug used for the treatment of epilepsy. The study will use positron emission tomography (PET scan) to detect areas of the brain receiving increased blood flow and using increased amounts of glucose. Increases in blood flow and glucose use are good indicators of brain activity. Researchers are interested in determining the effects of Vigabatrin on brain blood flow and glucose use.

Ictal SPECT with intravenous injection in a cubital vein of a perfusion tracer is an established technique to localize the ictal onset zone during presurgical evaluation of refractory focal epilepsy. When seizures last less than 10 seconds, localizing information is often not obtained. Since it takes around 30 seconds before the tracer reaches the brain after intravenous injection, ictal hyperperfusion most likely has already switched to postictal hypoperfusion. In this study, we plan to inject the perfusion tracer in the aorta proximal to the cerebral arteries, which will allow a true ictal injection in patients with seizures of short duration.