An Open Label, Randomised, Repeat Dose Study to Assess the Pharmacokinetic Performance of Five Ezogabine/Retigabine...
EpilepsyThis is an open-label, single centre, repeat dose, up- titration study in healthy male and female subjects to assess the pharmacokinetic (PK) performance of five prototypes of ezogabine modified release tablet formulations. The study will consist of a screening period, a treatment phase (consisting of a titration phase, bioavailability phase and food effect phase) and a post-treatment follow-up visit. The study duration from screening to follow up will be approximately 7 weeks. No study procedures will start before informed consent is obtained. Subjects will remain in the clinical unit for the duration of the treatment period (35 days). Subjects will receive repeat doses of ezogabine for up to 34 days starting at a dose of 100 mg IR TID (300mg TDD) with a standard meal (to be consumed 30 min prior to dosing) for Days 1-3, on days 4-6 subjects will receive 150mg IR TID (450mg TDD). On Day 7 through to the end of the study subjects will receive ezogabine (Mr or IR) at a dose of 600mgTDD. On Day 7 subjects will enter into a 6-way cross over period to investigate the 5 MR formulations being tested (each at 300mg BID) and the single IR formulation (at 200mg TID). Subjects will receive each formulaition for 4 days and blood samples for pharmacokinetic analysis will be collected up to 24 hours post dose on each 4th day (PK days). On Day 31 subjects will enter into a food effect phase to investigate the 5 MR formulations being tested (each at 600mg QD). Subjects in this period will have a PK day on Day 33 (following a standard breakfast), and on Day 34 (following a high fat breakfast) to investigate a food effect on the PK profile of ezogabine.
A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
EpilepsyGeneralized Tonic-clonic SeizuresTo evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).
Add on Lacosamide Versus High Dose Monotherapy
EpilepsyThis is a study to determine whether a combination of low dose lacosamide and levetiracetam is more effective than high dose levetiracetam in patients who have failed low dose levetiracetam.
Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset...
EpilepsyThe purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
Polyunsaturated Fatty Acids for Adjunctive Treatment of Refractory Epilepsy
EpilepsyWe are studying whether the addition of fish oil capsules, containing 2.2 gm of polyunsaturated fatty acids, when added to antiepileptic drugs improve seizure control.
Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy...
EpilepsyPartialThe purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.
Comparison of Immediate vs Gradual Switch to Divalproex in Adults With Intellectual Disability
EpilepsyThe purpose of this study is to determine whether there is any difference in side effects experienced by individuals with intellectual disorders taking Depakote DR (immediate release form) when they are switched to the extended release form (ER) overnight versus when they switch more gradually over a week.
Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy...
EpilepsyFor ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe. To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.
A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
EpilepsyThis is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.
Transcranial Magnetic Stimulation and Anti-epileptic Effect: Optimization and Evaluation With Electrophysiology....
Refractory Frontal Lobe EpilepsyEpileptic disease is characterised by enhanced brain excitability. Low frequency repetitive transcranial magnetic stimulation (rTMS) can be an effective treatment for refractory frontal epilepsy. Thought, physiological mechanisms of its effectivity are still unknown. It is yet possible to evaluate cortical excitability and inhibition with TMS-coupled electromyography before and after rTMS sessions ; this could provide clues for basic mechanisms of rTMS effects on the epileptic brain. We assume that rTMS decrease brain excitability by improving brain inhibition. Such an information could help for treating patients with both pharmacological and non-pharmacological methods.