Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure...
EpilepsyThis study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased seizure activity.
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy
Partial EpilepsySurgeryThe main objective of the study is twofold: Assess the clinical efficacy of DBS on epilepsy according to their number and severity at 1 year follow up. Perform a cost-effectiveness analysis from the perspective of Medicare at 1 and 2 years. The study hypothesis is that thalamic DBS (neurostimulation of the anterior nucleus of the thalamus) will decrease significantly, the frequency (potentially 50% reduction in severe crises) of the most severe seizures, in at least 50% of patients who have drug-resistant partial epilepsy; and should also improve significantly the quality of life through a gain of independence in activities of daily life, the possible recovery of functional abilities, recovery of social or professional activities.
Switchability Study Between Brand and Generic Topiramate
EpilepsyThe purpose of the study is to prove the bioequivalence of brand and generic topiramate.
Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital...
Status EpilepticusEpilepsyThe main purpose of this study is to know on one hand if lorazepam is more (effective) than clonazepam and on the other hand if lorazepam is also effective as the association clonazepam + fosphenytoin in out-of-hospital treatment of the generalized convulsive status epilepticus in adult patients.
A Long-term, Safety, Tolerability, and Efficacy Study of Retigabine Immediate-release (IR) in Asian...
EpilepsyThis is a multicentre, long-term, open-label extension (OLE) study to assess the long-term safety, tolerability and efficacy of retigabine immediate-release (IR) as adjunctive therapy in adult Asian subjects with drug-resistant partial-onset seizures (POS).
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide...
EpilepsyPartial-onset SeizuresThe purpose of this trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 [NCT01710657]
Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously...
EpilepsyTrial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis testing will be performed.
The Clinical Application and Mechanism of Music Therapy (Mozart's Effect) on Epilepsy
SeizureMusic has a long history in healing physical and mental illness. The Mozart effect was initially reported by Rauscher, Shaw, and Ky in the journal of "Nature" in the year of 1993. They examined performance on Stanford-Binet spatial tasks immediately following either 10 minutes of listening to Mozart's sonata K.448, silence, or instruction to relax. They found the performance scores were 9 point higher in Mozart-listening group than other two groups. Later, the beneficial influence of Mozart music on parkinson's disease, epilepsy, senile dementia, and attention-deficit/hyperactivity disorder was reported. However, the real neurophysiological mechanism of the influence remains unclear. Epilepsy is a common disorder in the field of pediatric neurology. Although we had greatly advanced in develop of new anticonvulsant, thirty percent of patients with epilepsy have drug-resistance, which is associated with an increased risk of debilitating psychosocial consequences. In addition, the adverse effects of anticonvulsants are not uncommon. Few reports demonstrated that patients exposed to Mozart's music can significantly decrease in seizure frequencies and interictal epileptiform discharge. However, the case number of these studies was limited and the mechanisms of music therapy on epilepsy were not well known. In our recent studies, Mozart's music indeed decreased the epileptifrom discharge in the patients with epilepsy, particularly in the patients with generalized discharge and central discharge. On the basis of these encouraging results, we will try to investigate the neural mechanisms and clinical applications of music therapy in the following three years. In the first year of our study, we use animal model to examine the possible mechanism of Mozart's effect. The aim of the second year study is investigation the effect of music on the cortical functions in the epileptic rat model. According to our previous study, Mozart's sonata K.448 was effective in reducing epileptiform discharge. On the basis of previous two-year results, the patients with epilepsy will be enrolled in the third year project to perform an individualized music therapy. In this study, we can provide an alternative therapy in the patients of epilepsy and investigate the possible biological mechanism of music effect.
The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA...
EpilepsyThe purpose of this study is to investigate the effect of food on the pharmacokinetics of a single 800 mg oral dose of BIA 2-093 in healthy volunteers.
Safety of Autologous MSC Infusion to Treat Epilepsy
Epilepsy• The goal of this study was to evaluate the safety and efficacy of autologous MSC application for the therapy of drug-resistant symptomatic epilepsy. Adult (18-60 years old) patients (pts) of both sexes suffering from refractory epilepsy with frequent (>5 events per month) seizures were included in this study. The pts were randomized to the standard treatment with anti-epileptic drugs (control group, 30 pts) or anti-epileptic drugs plus autologous mesenchymal stem cells (MSCs) (study group, 30 pts). The pts in the study group received one intravenous injection of ex vivo expanded MSCs (40-101 x 106 cells) and one subsequent endolumbal injection of neuroinduced MSCs (2.7 - 8.0 x 106 cells). Both the unfavorable reactions to MSC infusions and the clinical effects, including complications, were examined. The unfavorable reactions to the MSC injections included local pain or hemorrhage at the site of injection and systemic reactions of the central nervous system (CNS; i.e., hyperthermia, fatigue, and myalgia).The possible beneficial effects of therapy in the two groups of pts were examined based on clinical observations and electroencephalography measurements (prior and 12 months after the application of the MSC-based therapy). To determine potential changes in disease progression, the signs of cognitive impairment, behavioral disorders, and particularly, changes in seizure character and frequency were evaluated using the National Hospital Scale of Seizure Severity. The main points of disease monitoring were "yes" or "no" responses (to therapy), seizure frequency (per month), and remission of disease. Electroencephalography (EEG) recordings were performed to evaluate electrical alpha, beta, theta and delta waves based on standard and additional criteria. The paroxismality index, the peak frequency of EEG activity, the index of slow activity, and the summarized points of EEG pathology signs were calculated for each patient. All assessments were performed for the pts in the control and study groups, and the obtained data were compared to identify the potential differences between the two pts groups. Therapy was terminated when immediate unfavorable reactions to the MSC injections were observed. The final observation of each patient included clinical and EEG assessments at the time point of 12 months (or more) after the application of the MSC-based therapy.