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Epilepsy clinical trials

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NCT ID: NCT01660672 Completed - Epilepsy Clinical Trials

Enteral Levetiracetam For Seizure Control In Pediatric Cerebral Malaria

LVT1
Start date: January 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20% and leaving one third of survivors with long term neurologic and psychiatric sequelae. Seizures occur commonly with CM and are associated with an increased risk of death and neuropsychiatric disabilities. In this Malawi-based, dose- escalation, safety and feasibility study of enteral levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity of pediatric CM.

NCT ID: NCT01657864 Completed - Epilepsy Clinical Trials

WEUSKOP6166: Lamotrigine and Aseptic Meningitis

Start date: May 2012
Phase: N/A
Study type: Observational

The objective of the study is to quantify the number of cases of aseptic meningitis among users of Lamotrigine. This study is a cross-sectional study design using data on lamotrigine patients within the Thomson Reuters MarketScan® Commercial database (MarketScan database). The MarketScan database is a US-based insurance claims database representative of a US insured population and includes supplemental datao n Medicare patients. This cross-sectional study will evaluate the number of cases of aseptic meningitis among lamotrigine users during the duration of lamotrigine therapy, with an extended exposure window of 30 days after completing therapy. The MarketScan® Database is an US insurance claims database that is held in-house at GSK, which can be interrogated to examine rates of prescribing and medical conditions that can be captured via ICD-9 diagnoses codes. The MarketScan database captures person-specific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. The annual medical databases include private sector health data from approximately 100 payers. In 2011, there were approximately 35 million patients on the database. The Commercial Claims and Encounters Database represents the medical experience of insured employees and their dependents for active employees, early retirees, COBRA continues, and their dependents insured by employer-sponsored plans (i.e., non-Medicare eligibles). In addition, a linked Medstat Medicare database contains predominantly fee-for-service plan data in insurance plans where both the Medicare-paid amounts and the employer-paid amounts were available and evident on the claims.The data are HIPAA compliant thus all patients have been anonymized.

NCT ID: NCT01657084 Completed - Epilepsy Clinical Trials

Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask

EpiCapno
Start date: September 2012
Phase: N/A
Study type: Interventional

By enabling a partial rebreathing of expired gas, a moderate respiratory acidosis is induced, without causing hypoxia in the patient. Based on the scientific literature on the subject, the study hypothesis is that the fall in body pH will be able to stop and/or prevent epileptic brain activity.

NCT ID: NCT01653262 Completed - Epilepsy Clinical Trials

Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV)

Start date: July 2012
Phase: Phase 3
Study type: Interventional

Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis testing will be performed.

NCT ID: NCT01648101 Terminated - Epilepsy Clinical Trials

Assessment of the Efficacy and Safety of 2 Doses of Retigabine Immediate Release (900 mg/Day and 600 mg/Day) Used as Adjunctive Therapy in Adult Asian Subjects With Drug-resistant Partial-onset Seizures

Start date: August 29, 2012
Phase: Phase 3
Study type: Interventional

The immediate release (IR) formulation of retigabine has been shown to be superior to placebo as adjunctive therapy in 3 adequate and well-controlled studies in subjects with drug-resistant partial-onset seizures (POS) who had previously failed to respond to two or more antiepileptic drugs (AEDs) and were still having seizures despite current treatment with 1, 2, or 3 AEDs. However, of 1244 subjects randomly assigned to treatment in these 3 clinical studies, only 10 were Asian subjects and only 5 of these Asian subjects were randomly assigned to treatment with retigabine. Therefore, this Phase III study is being conducted to evaluate the efficacy, safety and tolerability, and health outcomes of retigabine, at doses of 900 mg/day and 600 mg/day, compared with placebo in adult Asian subjects with drug-resistant POS.

NCT ID: NCT01645072 Unknown status - Refractory Epilepsy Clinical Trials

Low Glycemic Index Diet Therapy in Children With Refractory Epilepsy

Start date: June 2011
Phase: Phase 3
Study type: Interventional

Epilepsy is a frequent cause of morbidity in the pediatric age group. Many catastrophic epilepsies present during infancy and childhood1. Seizures in these epileptic disorders are difficult to control; sometimes only at the expense of multiple and toxic levels of antiepileptic medications. The shortcomings of antiepileptic drug therapy and epilepsy surgery warrants the need for alternative treatments. Ketogenic diet is effective for refractory epilepsies (33% of patients with refractory epilepsy have more than 50% reduction in seizures from the baseline and 15-20% become seizure free) and has gained widespread acceptance. Low glycemic index diet treatment (LGIT) is designed as a variant of ketogenic diet. There are retrospective studies on LGIT in childhood refractory epilepsy reporting seizure reduction comparable to that of patients on ketogenic diet. There have been no randomized controlled trials assessing the efficacy of the low glycemic index diet in refractory epilepsy. In this study we plan to assess the efficacy of LGIT among children with drug refractory epilepsy.

NCT ID: NCT01630785 Enrolling by invitation - Clinical trials for Patients Operated on at the Neurosurgery Department

Neurophysiological Intraoperative or Epilepsy Monitoring

nphysdocu
Start date: January 2012
Phase:
Study type: Observational [Patient Registry]

The investigators record the outcome of patients whose surgery involved intraoperative neurophysiological monitoring - Trial with surgical intervention

NCT ID: NCT01627860 Completed - Epilepsy Clinical Trials

First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients

TEAMS
Start date: February 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to examine seizure control and tolerability of Topiramate after either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.

NCT ID: NCT01626599 Completed - Epilepsy Clinical Trials

Study to Evaluate a New Device Designed to Collect Heart Activity and Body Movement Data

Start date: June 2012
Phase: N/A
Study type: Interventional

This study is designed to collect data to support development of a novel product designed to sense changes in heart rate or movement during periods of sleep in people with epilepsy. When a potential seizure is detected, the system sends out an audio-visual notification.

NCT ID: NCT01613911 Completed - Epilepsy Clinical Trials

Study of Human Sensory Perception

Start date: March 2012
Phase: N/A
Study type: Observational

This study will help describe how the human brain works when a person sees something, hears something, learns something, or thinks about something by recording brain activity that occurs when the person does a series of computer tasks. This study will be offered to people who are in the hospital to be monitored for epilepsy by using electrodes placed in the brain. The study will record brain activity that occurs when a patient does a memory task, for example.