An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Two-way Crossover,...
EpilepsyAn Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Two-way Crossover, Oralcomparative Pharmacokinetic(PK)Study of Lacosamide Extended-Release Tablets , Adult, Human Subjects Under Fasting Conditions. Main purpose: To the Overseas Pharmaceutical,Ltd. Developed lacoxamide slow-release tablets (specification: 100mg) for the test preparation, UCB produced rasoxamide tablets (trade name: VIMPAT®, specification: 50mg) for the reference preparation, compare the fasting state of oral test preparation and reference preparation in Chinese healthy subjects blood concentration and main pharmacokinetic parameters, to evaluate the biological equivalence of test preparation and reference preparation. Secondary objective: To evaluate the safety of the test sustained-release tablets and reference tablets in the healthy Chinese subjects.
Neural Basis of Cognition
EpilepsyThe overall purpose of this study is to better understand human cognition and human epilepsy by working with patients undergoing clinical treatment for pharmacologically resistant epilepsy. The investigators will investigate human cognition by conducting controlled experiments that focus on sensory, motor, and cognitive phenomena such as sensory processing, memory, and language. The investigators will also examine the neural underpinnings of epilepsy during both sleep and wakefulness to better understand both the foundations of epilepsy and how epilepsy affects cognition. The investigators hope to use these data to have a better understanding of cognition, epilepsy, and how the two interact. This will potentially lead to better markers for seizure onsets as well as epilepsy more generally. For this research, the investigators will use μECoG arrays manufactured by commercial partners. These arrays have passed all major ISO 10993 bio-compatibility tests. Based on this characterization and use in the intraoperative setting (limited duration and supervised usage), these devices pose a minimal risk to participants. Data will be analyzed and protected using the Duke SSRI protected research data network.
Effect of Vagal Nerve Stimulation on Gastric Motor Functions
EpilepsyDepressionThe specific aim of this study is to compare simultaneous assessment of gastric emptying and gastric accommodation in response to the same caloric meal before and three months after activation of left cervical VNS. Our hypothesis is that cervical VNS increases gastric accommodation and accelerates gastric emptying.
Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy: Clinicolabratory Study
EpilepsyLamotrigine1 moreEpilepsy is one of the most common serious chronic brain disorders of childhood. The causes of epilepsy include :acquired brain damage, altered metabolic states, inborn brain malformations, and genetic causes. At present, antiepileptic drugs (AEDs) are the first line therapy for resistant epilepsy (RE) , and the second line is surgery , and vagus nerve stimulation . Sodium valproate (SV) is a first line anti epileptic drug that can be applied to various seizure types in children . SV has anticonvulsant activity through regulation of neuronal pathways . It has a molecular structure similar to neurotransmitter γ aminobutyric acid (GABA) resulting in GABA synergism , A serious adverse effect of the valproic acid (VPA) : is its effect on liver function with resultant drug-induced hepatotoxicity, hyperammonemia . Lamotrigine (LTG) is a second generation AED . LTG belongs to the sodium channel blocking class of antiseizure medications (ASMs). Lamortigine side effects include severe rash, fever, lymphadenopathy, hepatic dysfunction, blood disorder,and disseminated intravascular coagulation and Stevens-Johnson syndrome (SJS) . the aim : Evaluation of the efficacy and safety of adding lamotrigine to sodium valproate in epileptic children not responding to SV alone for 6 months. Moreover, the investigators will evaluate the effects of this addition ,appearance of side effects,laboratory evaluation and EEG changes 50 epileptic patients receive SV for 6 months without complete remission for participants, the investigators will add lamotrigine for 6 months.
Cardiovascular Risk Reduction in Epilepsy
EpilepsyHypertension2 moreEpilepsy is a disabling and lethal neurological disease which affect 3.47 million Americans. Significant health care disparities exist in people with epilepsy (PWE). Hypertension and hyperlipidemia are highly prevalent and often go undertreated, and cardiovascular (CV) mortality is higher in people with epilepsy (PWE) than the general population. Preliminary data from our group shows that PWE have higher ACC-ASCVD risk scores than an age matched NHANES cohort without epilepsy. Preliminary data also demonstrate mortality rates in PWE due to hypertension, stroke, and diabetes are rising in the US, counter to the US general population. This proposal seeks to test the feasibility, acceptability, and preliminary efficacy of a new care model for the underserved PWE in a public health setting. In this new model, neurologists guided by standardized treatment algorithms (ACC-ASCVD estimator+) propose and initiate pharmacological interventions for hypertension and hyperlipidemia.
Comitial Prophylaxis in Neurosurgery in Patients Who Have Undergone Intracranial Surgery Programmed...
Anti-epileptic Prophylaxis in Intracranial NeurosurgeryJUSTIFICATION Anti-epileptic prophylaxis has long been a systematic practice for supra-tentorial intracranial surgeries. Since 2021, European guidelines no longer recommend this prophylaxis and practices have evolved. We therefore propose to compare epileptic seizure's occurrence in the first postoperative month between two groups of neurosurgical patients.The first group consists of patients treated between January 2019 and late 2020 who were given systematic prophylaxis. Patients from the second group were treated between 2021 and 2022 and did not receive any prophylaxis. The secondary objective will consist in identifying the number of patients placed on prophylaxis, the length of prophylaxis, treatment's side effects (depression, elevated liver enzymes…), and comparing patients' neurological outcome at 3 and 6 months after surgical procedures.
An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy...
Highly Drug-resistant Focal EpilepsyThe purpose of study EP0073 is to assess the long-term safety, tolerability, and efficacy during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant focal epilepsy. Also, the effects of UCB0942 on the patient's quality of life will be explored.
Perampanel for Treatment of Adults With Refractory Focal Epilepsy : a Pilot Study.
EpilepsyThe goal of the present study is to evaluate ("screen") a large number (12) of different dual therapies of perampanel + another AED ("PMP+") for a large, 75-100% seizure frequency reduction. The design of the study will differ from usual AED studies. The study will be (i) open label, with (ii) a small n per group, n=6, with (iii) outcome measures a 'blockbuster effect': (a) ≥75 seizure frequency reduction; and (b) seizure freedom.
Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures...
Drug-Resistant EpilepsyFocal-Onset SeizuresThe purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.
Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.
EpilepsySeizures1 moreMulticenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.