View clinical trials related to Epilepsy.
Filter by:This a multi-center study to examine whether supplementation with omega 3 fatty acids will reduce seizure frequency in patients with epilepsy .
The objective of this study was to confirm if two formulations of gabapentin (capsules) are bioequivalent. Test product was Darbetin® 300 mg (Laboratorios Dermatológicos Darier) and reference product Nerotin® 300 mg (Pfizer). One capsule was the single dosage. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. The population was composed of 26 healthy volunteers, both genders, adults between 18-55 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.
Electroencephalography (EEG) with very high spatial resolution (HR-EEG, 256 electrodes) allow for better analysis of local and global activity of the cerebral cortex, as compared with conventional EEG. Since January 2012, the Neurology Department of CHU Rennes is the first clinical service in France equipped with such a system. Applied to HR-EEG recordings, brain connectivity methods are likely to provide essential information (in the form of "connectivity graphs") on cortical networks, either dysfunctional or not, involved in the generation of interictal paroxysms (like spikes or spike-waves) and during seizures. So far, many methods have been proposed (see for a review: Wendling et al., 2009; Wendling et al., 2010). However, since each method is highly sensitive to the type of model that is assumed for the underlying relationship between distinct brain regions (Ansari-Asl et al., 2006), none of them has yet demonstrated its effectiveness.
Epilepsy is the most common chronic neurological disorder in the world, affecting more than 50 million people worldwide. Approximately 35% of patients with epilepsy are refractory to all available antiepileptic drugs. Drug-resistant epilepsies are often partial or focal. Patients with drug-resistant focal epilepsy suffer from an increased risk of death, primarily due to seizure-related fatalities, in comparison with the general population. The only therapeutic option for this form of epilepsy is the surgical removal of the region of the brain responsible for seizures, called the epileptogenic zone (EZ). This requires the precise localization of the EZ based on a comprehensive pre-surgical evaluation of patients. Today the gold standard for localizing the EZ and validating a non-invasive technique for localization of the EZ remains intracerebral stereo-EEG (stereo-electroencephalography or SEEG) recordings of spontaneous seizures. The implementation strategy of the intracerebral depth electrodes is guided by clinical and neuroimaging data, including anatomical Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) with FDG (fluoro-Deoxy-Glucose) and MagnetoEncephaloGraphy (MEG). Although the contribution of each technique in the pre-surgical localization of the EZ has already been shown, no wide-scale study has examined the cumulative contribution of these three techniques.
The United States Food and Drug Administration (FDA) has specific rules which generic drug companies must follow to get a generic copy of a seizure medication approved. Currently, FDA approves generic drugs by requiring studies on normal volunteers who don't have epilepsy and who take just one dose of the generic drug followed by a series of blood tests. Some people with epilepsy and their physicians have complained about side effects or loss of seizure control when taking generic drugs, but no one knows if these complaints are truly because of problems with the generic drugs. This research is to determine whether several different generic versions and the brand version of the medication lamotrigine perform in a similar way when given to people with epilepsy. The study drug Lamictal® (lamotrigine) and both of the generic forms of lamotrigine to be tested are approved by the FDA for the treatment of seizures.
Epilepsy is one of the most common neurological disorders affecting women of childbearing age. Poor pregnancy outcomes are increased in these women and their children. The proposed studies will increase our knowledge on multiple levels to improve care and reduce adverse outcomes in these mothers and children. An overall goal of this study is to establish the relationship between antiepileptic drug exposure and outcomes in the mother and child as well as describe and explain the variability in antiepileptic drug exposure and response.
N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life and to explore the direct medical resource use for BRV (for subjects entering N01372 from a study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of 200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.
The purpose of this study is to evaluate the effect of different intravenous doses (IV) of a new anti-epileptic drug (AED) called lacosamide on continuous EEG (electroencephalogram) rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those doses by patients. In addition, this study will assess the effect of IV lacosamide on EKG (electrocardiogram), a test which checks for problems with the electrical activity of the heart.
As part of a European post-marketing commitment, GSK will conduct a survey of physicians' and patients' understanding of the significant risks associated with Trobalt™ (retigabine), as described in the Patient Information Leaflet (PIL) and the Physician's Guide. The goal of the surveys is to evaluate the effectiveness of the educational plan as specified in the European Risk Management Plan (RMP). The objectives of this study are to assess patients' and prescribers' understanding and knowledge of the significant risks associated with Trobalt™ use as evaluated by a survey instrument. This is a cross sectional survey of: 1. 250 patients recruited from across the following countries (United Kingdom, Sweden, Denmark, Switzerland, Spain, Slovakia and Norway) and up to 100 patients from Germany who are currently using or have filled a prescription for Trobalt™ at least once in the last 3 months. 2. 200 neurologists who have prescribed an anti-epileptic drug (AED) at least once in the last 3 months, and who were on the list to which a letter containing the Physician's Guide for Trobalt™ was distributed from across the following countries (United Kingdom, Sweden, Denmark, Switzerland, Spain, Slovakia and Norway). At least 75 of the neurologists will have prescribed Trobalt™. The survey will also aim to include up to 100 neurologists from Germany of which approximately 50 will have prescribed Trobalt™. Patients eligible for the survey will be asked to take the survey online or via a telephone interview if the latter is preferred. Neurologists will be invited to take the survey online. The selected countries were the first five countries to launch Trobalt™ (Germany, Denmark, United Kingdom, Switzerland and Sweden) and an additional three countries with launch in 2011, but with relatively high rates of uptake of Trobalt™ (Spain, Slovakia and Norway). The selection of countries includes Switzerland, which is not part of the European Union. However, the key messages regarding the risks with Trobalt™ are in alignment. The rationale for surveying the first five countries to launch is so that any issues identified from these countries regarding the effectiveness of the Physician's Guide and PIL in communicating the risks of Trobalt™ can be addressed as soon as possible, and the key messages can be revised in a timely manner. In addition, these countries are likely to provide the greatest number of neurologists with experience of prescribing Trobalt™, and their patients. The primary outcome of the survey is the proportion of patients/neurologists providing correct responses to a series of questions concerning the significant risks associated with Trobalt™. The risks evaluated will be those described in the Trobalt™ PIL and in the Physician's Guide.
The United States Food and Drug Administration (FDA) has specific rules generic drug companies must follow to get a generic copy of a seizure medication approved. Currently, the FDA approves generic drugs by requiring studies on normal volunteers who don't have epilepsy and who take just one dose of the generic drug followed by a series of blood tests. Some people with epilepsy and their physicians have complained about side effects or loss of seizure control when taking generic drugs, but no one knows if these complaints are truly because of problems with the generic drugs. When the FDA tests generic copies of lamotrigine (LTG), the blood levels measured after volunteers receive the generic lamotrigine tablets are allowed to fall within a specific range. This research will test whether two different manufacturer's generic lamotrigine, that fall in different parts of that range, perform in a similar way when given to people with epilepsy every day over a several week period. The two products will be called GENERIC A and GENERIC B. The generic forms of the study drug lamotrigine to be tested in this study are approved by the FDA for the treatment of seizures.