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Epilepsies, Partial clinical trials

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NCT ID: NCT02726919 Recruiting - Epilepsy Clinical Trials

Clobazam Adjunctive Treatment of Adults With Refractory Focal Epilepsy

Start date: February 2015
Phase: Phase 4
Study type: Interventional

The goal of the present study is to obtain pilot data on efficacy and safety of clobazam add-on treatment on adults with drug-resistant focal epilepsy. This will be an open label study comparing seizure frequency during 12 weeks of baseline observation period with seizure frequency during 16 weeks of clobazam adjunctive treatment. 10 adults aged 18-65 with focal seizures that have failed to respond to ≥ 4 antiepileptic drugs (AEDs) +/- respective surgery will be enrolled. Following a baseline of 12 weeks patients will be started on clobazam, administered orally in b.i.d. schedule. In patients in whom seizure diaries have been kept prospectively prior to study screening visit, retrospective baseline will be accepted. Patients will be titrated up to either seizure freedom, to side effects or to 40 mg/day, whichever comes first. Titration rate will be not be forced. It is anticipated that the majority of subjects will have a 4 week-long titration period. After maximum dose is achieved, maintenance treatment will last for 12 weeks.

NCT ID: NCT02648529 Completed - Clinical trials for Cryptogenic Epilepsy of Childhood

Brain Maturation in Children With Localization Related Epilepsy

DYNAMAT
Start date: September 2008
Phase: N/A
Study type: Interventional

This project intends to investigate children with idiopathic and cryptogenic localization related epilepsies, using a longitudinal assessment of structural and functional MRI data, in relation to neuropsychological evaluation. The rationale is primarily based on: 1) the frequent observation of selective cognitive dysfunctions in such children, the pathophysiology of which remains largely uncertain; 2) the recent major advances in the MRI investigation of brain maturation showing striking age and region dependant patterns. The primary hypothesis is that some children with localization related epilepsies suffer from altered maturation in the epileptic brain regions, and that this abnormal maturation affects their cognitive abilities. 100 children with localization related epilepsies and 100 matched controls will be prospectively enrolled during the first two years of the disease (for patients) and benefit from a comprehensive phenotypic and neuropsychological evaluation once a year for 5 years. The brain maturation of these children will be longitudinally assessed using structural and functional MRI, and correlated with neuropsychological data. Investigators hope to demonstrate that children with localization related epilepsies and cognitive dysfunctions suffer from an abnormal brain maturation in regions underlying the epileptic activity and the altered cognitive processes. The finding could partly bridge the gap between these two abnormalities and help better understand their interaction and respective dynamic. Once validated, the study of regional brain maturation in children with epilepsy might be further used as a reliable surrogate marker or predictor of associated cognitive dysfunction.

NCT ID: NCT02635633 Terminated - Epilepsies, Partial Clinical Trials

Continuous Thetaburst Stimulation for the Treatment of Refractory Epilepsy - Safety, Feasibility and Proof-of-concept

Start date: August 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate a novel stimulation protocol of repetitive transcranial magnetic stimulation (rTMS) for the treatment of unifocal neocortical epilepsy, namely continuous thetaburst stimulation (cTBS). As this is a pilot study, the primary endpoint is on safety and tolerability of the treatment. However, information on clinical efficacy and mechanism of action will also be collected.

NCT ID: NCT02625090 Terminated - Clinical trials for Highly Drug-resistant Focal Epilepsy

An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

Start date: December 3, 2015
Phase: Phase 2
Study type: Interventional

The 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.

NCT ID: NCT02572297 Completed - Clinical trials for Drug-resistant Partial Epilepsy

National Network for the Study of Predictors and Prevention of Sudden Unexpected Death in Drug-resistant Partial Epilepsies

REPOMSE
Start date: May 18, 2010
Phase: N/A
Study type: Observational [Patient Registry]

Sudden unexpected death in epilepsy (SUDEP) is the main concern of professionals and patient associations involved in epilepsy. These represent a priority for the Ligue Française Contre l'Epilepsie (LFCE). The SUDEP affect primarily young adults, between 18 and 40 years, suffering from epilepsy uncontrolled by medication. In this population of close to 100,000 people in France, the incidence of SUDEP is estimated at 0.5%, or nearly 500 deaths per year. It is clear that the majority of these deaths occur in the immediate consequences of a crisis.. Investigators suppose that a causal link exists between the occurrence of a SUDEP and a per / post-critic decline of SpO2 below 80 % (75 % of cases, 20 % of controls).The constitution of a cohort of 1500 patients clinically well described and a national database will allow other ambitious projects in a speciality where French centres benefit from a unique knowledge, recognized by their foreign colleagues, but underexploited to date. The LFCE (Ligue Française Contre l'Epilepsie) is developing structuring actions to facilitate such exploratory studies for the next two years. The high death rate which characterizes the drug-resistant partial epilepsies and, in particular, Sudden Unexpected Deaths in Epilepsy (SUDEP) represents the main axis of research for the Ligue Française Contre l'Epilepsie (LFCE) as well as for associations of epileptic patients and the European representatives of the international league against epilepsy ( ILAE). Today, SUDEP occurrences cannot be anticipated. Patients can't be warned against SUDEP. Although the SUDEP physiopathology remains uncertain, many elements plead for the essential role of a per-and post-critic apnea (central or obstructive). Investigators observe that about 20 % of the patients admitted in a EEG-video monitoring - EEG unit for recording their crisis are going to present experience an per / post-critic severe apnea, severe per / post-critic enough to have induce a SpO2 < 80 % decrease. However, today, no study has estimated the link relation between the arisen occurrence of such apneas and the later risk of SUDEP.

NCT ID: NCT02535091 Completed - Partial Epilepsy Clinical Trials

Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Start date: August 3, 2016
Phase: Phase 3
Study type: Interventional

This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089 as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking phenytoin or phenobarbital will be enrolled followed by additional subjects taking anti-epileptic drugs (AED) other than phenytoin and phenobarbital to further investigate long-term safety.

NCT ID: NCT02495844 Completed - Clinical trials for Highly Drug-resistant Focal Epilepsy

A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

Start date: July 2015
Phase: Phase 2
Study type: Interventional

This study is to assess the efficacy, safety, and tolerability of the investigational drug UCB0942in adult subjects with drug-resistant focal epilepsy across multiple centers in Europe.

NCT ID: NCT02491476 Completed - Epilepsy Clinical Trials

Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy

Epi-FaR
Start date: March 2015
Phase: N/A
Study type: Interventional

The main objective of this study is to evaluate the feasibility of recording fast-ripples, a potential new biomarker of epilepsy, using the new micro-macroelectrodes developed by Dixi-Medical.

NCT ID: NCT02465970 Completed - Epilepsy Clinical Trials

Effects of Transcranial Direct Current Stimulation (TDCS) in Drug-resistant Partial Epilepsy

BRAINSTIM
Start date: November 13, 2015
Phase: Phase 2
Study type: Interventional

Drug-resistant partial epilepsy has a heavy impact on quality of life and sometimes on life expectancy itself. Only a minority of patients may benefit from a curative epilepsy surgery. Neurostimulation, which can be an effective add-on treatment, is currently mainly represented by vagus nervus stimulation. Transcranial direct current stimulation, a non -invasive technique already used in other areas of neurology, may be efficient on some partial epilepsies, in particular through the individual configuration of stimulation, made possible by recent technological advances. Main goal : To study the effect of transcranial electrical stimulation on the frequency of seizures in patients with drug-resistant partial epilepsy. Hypothesis : Reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured TDCS session: responders in real TDCS vs placebo stimulation.

NCT ID: NCT02458820 Completed - Seizures Clinical Trials

Prompt Diagnosis and Treatment of Subclinical Seizures After Cardiac Arrest

Start date: June 2015
Phase: N/A
Study type: Interventional

Non-convulsive seizures (NCS) following cardiac arrest are common and are associated with worse neurologic outcomes and increased mortality. More prolonged seizures (status epilepticus) are associated with worse outcomes. Earlier diagnosis and treatment of seizures may lead to earlier termination of seizures and decreased seizure burden. This study will evaluate whether bedside intensive care unit (ICU) provider interpretation of a type of EEG called DSA EEG can be used by non-neurologists to diagnosis seizures more rapidly than continuous EEG's routinely read by neurologists.