Cannabidiol (CBD) to 27 Patients (Aged 2 Years - 19 Years) With Drug Resistant Epilepsy
EpilepsyPart A: To evaluate the safety and tolerability of multiple ascending doses of GWP42003-P compared with placebo with respect to: Incidence, type and severity of adverse events (AEs) Effect on vital signs, including weight Effect on 12-lead electrocardiogram (ECG) findings Effect on laboratory parameters Part B: To make an assessment of the anti-epileptic efficacy of GWP42003-P compared with placebo with respect to the incidence in convulsive seizures To determine the plasma concentration time curves for GWP42003-P and its major human metabolite, following escalating multiple doses of GWP42003-P. To investigate the effect of GWP42003-P on the pharmacokinetics of concomitant anti-epileptic drugs (AEDs). To evaluate cognitive function, sleep quality and daytime sleepiness, in patients taking GWP42003-P in combination with AEDs.
Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic...
EpilepsyAssessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects >= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 [NCT02408523] study.
The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 100mg Compared With Compressed...
EpilepsyThis is an open-label, randomised, parallel-group study to demonstrate the bioequivalence of lamotrigine 100mg in two different formulations, dispersible/chewable tablet and compressed tablet, in healthy subjects under fasting conditions. Subjects will be randomized in equal numbers to be dosed with either lamotrigine dispersible/chewable (Test) 100mg tablet or lamotrigine compressed (Reference) 100mg tablet. Pharmacokinetic blood sampling will be collected over 216 hours post dose. Safety (tolerability) will be observed up to 216 hours post dose. Safety assessments will include regular monitoring of vital signs, ECG's, adverse events (AEs) and safety laboratory tests. A follow-up visit is scheduled within 10-17 days post-dose.
Effect of Haemodialysis on the Pharmacokinetics of Ezogabine/Retigabine and Its N-acetyl Metabolite...
EpilepsyThis in an open-label, single dose, fixed sequence, two treatment period study enrolling 8 patients (to obtain 6 evaluable) with end stage renal disease (ESRD) receiving haemodialysis. Patients will remain in the unit during each treatment period from admission to the collection of the final PK sample. The doses of ezogabine/retigabine in the two treatment periods will be separated by at least 7 days.
Evaluating a Novel Internet Intervention for Persons With Epilepsy and Depression
DepressionEpilepsyThe trial aims to evaluate the effectiveness of a novel internet intervention (Desiconnect), which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to Persons with Epilepsy (PwE) and comorbid depression. Therefore, 200 PwE and a current depressive disorder (major depressive disorder or dysthymic disorder) will be recruited and randomized to two groups: (1) a control group, in which they may engage with any epilepsy treatment (Care-as-Usual, CAU) and receive access to Desiconnect after a delay of three months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately receives six-month access to Desiconnect and may also use CAU. The primary outcome measure is the depression scale of the Patient Health Questionnaire (PHQ-9), collected at three months post-baseline.
Efficacy of 128-channel EEG Combined With BESA Dipole Localization and Intervention on Brain Waves...
EpilepsyThe prevalence of epilepsy is about 0.5% to 1% worldwide, with high disability and mortality rate. The 128-channel electroencephalograph (EEG), combined with BESA dipole localization method, is able to provide more specific information about the brain activity and find out the epileptogenic focus. Based on this novel EEG recording method, cathode transcranial direct current stimulation (tDCS) targeting the epileptogenic focus can be used to decrease the excitability of the cortex, thus reducing the frequency of seizures. A single-center double-blinded randomized controlled and open-label extension trial will be carried out to study the efficacy of 128-channel electroencephalograph combined with BESA dipole localization method and Intervention on brain waves for epilepsy.
A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset...
Epilepsy With Partial On-set SeizuresA study of a drug to be used in addition with another drug to treat adults with Uncontrolled Partial-onset Seizures
Low Frequency TMS for Depression in Epilepsy
EpilepsyDepressions1 moreThe purpose of this study is to determine if low-frequency transcranial magnetic stimulation (TMS) is safe and feasible for treating depressive symptoms in patients with epilepsy. Patients will receive an accelerated protocol of TMS consisting of three consecutive days of treatment. Patients will have in-person follow up visits after one month and again after six months.
Effects of Perampanel on Cognition and Electroencephalography in Patients With Epilepsy
ElectroencephalographyPerampanel, a novel AED, has been recently authorized in Korea and worldwide as a treatment of refractory partial-onset seizures with a new anti-epileptic mechanism of a selective non-competitive antagonist of AMPA receptors. Evaluating adverse effects during the introduction of new AED is often difficult since the complaints are subjective and objective assessment is complicated due to the polytherapy. Majority of previous studies are focused on quantitative analysis of EEG for taking new AEDs because of the correlation of EEG analysis results and side effects of AED such as cognitive slowing. Therefore, this study aims to investigate the effects of perampanel on EEG in terms of EEG background spectra and to evaluate perampanel effects by using subjective questionnaires assessing depression, anxiety, sleep quality and fatigue.
Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)...
EpilepsyThe purpose of this study is to establish the feasibility, accessibility, acceptability, and preliminary efficacy of an individually-tailored intervention to improve EF in adolescents with epilepsy (EFI-E).