Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits
EpilepsyMethylphenidate (MPH) is a stimulant, FDA-approved for the treatment of attention deficit hyperactivity disorder (ADHD). It is unknown, however, if stimulants would be of benefit for memory and thinking problems due to epilepsy. In this study, participants will be assigned randomly (i.e., by flip of a coin), to a group that takes MPH and a group that takes a placebo (sugar pill). Participants will not know the group to which they have been assigned. Tests of attention and memory will be completed before taking the study pills and at Week 8. All participants will then have the option of taking MPH for the next two months, and attention and memory will be tested again at Week 16. The study will determine whether methylphenidate is helpful for the treatment of attention and memory problems in adults with epilepsy, and whether the medication is safe and beneficial when taken over an extended time period.
A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and...
SCN2A-DEEEpilepsyThe goal of this trial is to learn about the effect of PRAX-222 in pediatric participants with early onset SCN2A developmental and epileptic encephalopathy (DEE), aged 2 to 18 years.
Metformin Efficacy and Safety in Epileptic Patients
EpilepsyThe goal of this clinical trial is to Evaluating Metformin Efficacy and Safety when Co-administered with Antiepileptic Drugs in Patients with Seizures. The main question it aims to answer is: Does metformin have beneficial effect on epileptic patients? How metformin can affect epileptic patient's health? Participants will be divided into 2 groups (control group and treatment group) Control group will receive standard treatment (levetiracetam). Treatment group will receive standard treatment (levetiracetam) + metformin
Exogenous Ketone Esters for Drug Resistant Epilepsy
Drug Resistant EpilepsyThis study aims to investigate the efficacy of add-on exogenous ketone esters for treating children with drug-resistant epilepsy
Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of...
Epilepsy; SeizureThis project studies how 2-deoxy-glucose (2DG) pills are absorbed and distributed in people with epilepsy. 2DG is similar to glucose, the main energy source for the brain, but it cannot be used as energy. During seizures, neurons are at a very high metabolic state with huge glucose metabolism as glycolysis is accelerated to supply the high metabolic needs of a seizure. 2DG is taken up by cells but cannot be metabolized by the first enzyme in the glycolytic pathway, thus is stops, or "clogs up", glycolysis. Since brain metabolism is almost entirely dependent on glucose as an energy source, glycolysis is arrested and may stop seizures. It is hoped that 2DG will stop seizures by interfering with the brain's energy use. This is an open-label phase 2 study of the pharmacokinetics (PK), safety, and tolerability of 2DG administered orally to adult epilepsy patients. A 3-level 2DG dose escalation is planned in sequential cohorts of 3 subjects in each cohort with review of each cohort before proceeding to the next cohort. On the day of oral 2DG exposure, subjects will receive a single dose of 40 mg in the first cohort, a single dose of 60 mg in the second cohort, and two 60 mg doses (60 mg bid) in the third cohort. After 3 subjects have completed dosing at Dose Level 1 (40 mg/day), the safety and PK results will be reviewed. The Study Committee will determine if the next cohort should be enrolled at Dose Level 2 (60 mg/day). The same procedure will be repeated to determine if the next cohort should be enrolled at Dose Level 3 (60 mg bid = 120 mg/day). If the Study Committee determines that the most recent dose is not tolerated or that there are significant adverse events, the subsequent Dose Level will not be enrolled. A standard time-concentration curve will be constructed from the 2DG levels obtained from the PK blood draws. Parameters will be calculated for: time to maximum concentration (tmax), maximum concentration (Cmax), elimination rate, half-life (t1/2), AUC, and derived parameters. Statistical analysis will not be performed because of the small n, but this will nevertheless establish the PK profile of 2DG in people with epilepsy. The most important parameter will be the AUC which determines drug exposure.
Adjunctive Everolimus Treatment of Refractory Epilepsy
EpilepsyThis project is a prospective, randomized, placebo-controlled, double-blind study that will evaluate the clinical efficacy of everolimus as an adjunctive treatment in adult patients diagnosed with refractory epilepsy.
Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy
EpilepsySeizures1 moreThis study will evaluate the safety and tolerability of SPN-817 in adults with treatment resistant seizures
Impact of Thermocoagulation During Invasive EEG Monitoring in Children With Focal Drug-resistant...
EpilepsyWhen focal epilepsies become drug-resistant, it could be eligible for cortical surgical resection. Therefore, an invasive EEG monitoring with depth electrodes is often needed during presurgical evaluation. Some of these children can have access to thermocoagulation inside the ictal onset zone, at the end of the monitoring and before to remove the electrodes. These thermocoagulations can disorganize the epileptogenic network thanks to millimetric cortical lesions around the electrodes. The aim is to stop or at least, to reduce the seizure frequency for few weeks or months. This could be a benefit for the child, and also a confirmation of the ictal onset zone and guide the surgeon. This technique is currently used in adult population for years, but remains very rare in children.
Optimization of the Parameters of Vagal Nerve Stimulation
EpilepsyVagal nerve stimulation (VNS) is one of the neuromodulation techniques that can be indicated in patients suffering from refractory epilepsies, especially when an open resection has failed or is not indicated. However to date it is not possible to predict which patients will respond and what are the best parameters of stimulation to be set (pulse width, frequency and intensity). It has been shown that responders to VNS have reduced interictal cortical synchronicity on scalp EEG based on phase lag index (PLI), a marker of functional connectivity (Fc) The aim of this study is to test the following hypothesis: setting the parameters of stimulation on the basis of the lowest values of Phase Lag Index (PLI) obtained on scalp EEG with different settings of parameters (as compared with a randomly chosen set of commonly used parameters) will increase the rate of responders to VNS.
Integrating a Mental Health Intervention Into Primary Health Care for Refugees
Medication AdherenceMental Health Issue4 moreThe objective of this study is to evaluate the impact of an evidence-based mental health intervention (Common Elements Treatment Approach) on medication adherence, behavioral improvement and clinical outcomesamong adults taking medication for hypertension, diabetes and epilepsy using a two-arm randomized wait-list controlled trial among adult refugees in Mae La camp, Thailand.