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Epilepsies, Partial clinical trials

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NCT ID: NCT01587339 Completed - Epilepsy Clinical Trials

Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy

Start date: September 2010
Phase: N/A
Study type: Observational

There are a number of anti-epileptic drugs available for the treatment of partial onset seizures in patients with epilepsy. This study is a systematic review of the published literature on anti-epileptic drugs and is designed to compare the relative effectiveness and tolerability of a selection of them with retigabine. The drugs chosen for this comparison were lacosamide, pregabalin, tiagabine, zonisamide and eslicarbazepine. They were chosen because they belong to the newer generation of drugs for epilepsy (as does retigabine) and they have a similar license as well as having published data from studies that were conducted in similar patient populations with similar methods. GSK commissioned YHEC (York Health Economic Consortium) to carry out this review and analysis. YHEC identified relevant studies from international databases. These studies had compared one of the chosen anti-epileptic drugs with placebo. The results were pooled and combined in order to summarize the data for individual drugs as well to compare the results for different drugs with each other and with retigabine. Since none of the individual clinical studies compared one active drug with another, this systematic review is an indirect comparison of these drugs, using an established and recognised methodology which has well understood limitations.

NCT ID: NCT01527513 Completed - Partial Epilepsy Clinical Trials

Effects of Eslicarbazepine Acetate (Esl, Bia 2-093) on Cognitive Function in Children With Partial Onset Seizures

Start date: August 2010
Phase: Phase 2
Study type: Interventional

To evaluate the effects of eslicarbazepine acetate on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures.

NCT ID: NCT01498822 Completed - Epilepsy Clinical Trials

Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy

OPTIMAL
Start date: June 2011
Phase: Phase 4
Study type: Interventional

To evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment Failure Rate in subjects with newly diagnosed partial onset seizures with or without secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks from the first dose

NCT ID: NCT01463306 Completed - Clinical trials for Epilepsy, Partial Seizures

A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures

Start date: February 21, 2012
Phase: Phase 3
Study type: Interventional

Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.

NCT ID: NCT01457989 Completed - Epilepsy, Partial Clinical Trials

Meta-Analysis Plan for Pooled Data for Studies VRX-RET-E22-303 and VRX-RET-E22-304

Start date: August 2011
Phase: N/A
Study type: Observational

The objective of this meta-analysis is to provide data on long-term safety and efficacy following the recent positive Committee for Medicinal Products for Human Use (CHMP) opinion for retigabine using pooled data from ongoing open-label extension (OLE) Studies VRX-RET-E22-303 and VRX-RET-E22-304.

NCT ID: NCT01441401 Completed - Epilepsies, Partial Clinical Trials

Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)

Start date: December 2011
Phase:
Study type: Observational

This investigation aims to understand the following issues in pediatric patients, as well as to assess the need of a special investigation and a post-marketing clinical study: - The frequency of treatment related adverse events. - The frequency of efficacy assessment. - Treatment related unlisted adverse events in Japanese Package Insert. - Risk factors likely to affect the frequency of treatment related adverse event.

NCT ID: NCT01397968 Completed - Partial Epilepsy Clinical Trials

Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

Start date: July 6, 2011
Phase: Phase 2
Study type: Interventional

This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs. Also to evaluate the safety and tolerability of YKP3089.

NCT ID: NCT01389596 Completed - Clinical trials for Epilepsy, Partial Seizures

A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years

PERIWINKLE
Start date: September 27, 2011
Phase: Phase 3
Study type: Interventional

Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.

NCT ID: NCT01373190 Completed - Partial Epilepsy Clinical Trials

Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy

Start date: May 2011
Phase: N/A
Study type: Observational

The specific aim is to determine if there are patterns of temperature differences in the abdominal and back regions of individuals with partial/focal onset epilepsy as compared to a non-epileptic control group. The hypothesis is that individuals with partial/focal onset epilepsy will have colder recorded temperatures in the abdominal area than individuals in a matched control group.

NCT ID: NCT01332539 Completed - Epilepsy, Partial Clinical Trials

An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy

Start date: May 2011
Phase: N/A
Study type: Observational

observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective. As control group, 120 patients with controlled partial epilepsy will be enrolled. The objective of the study is to describe the burden of illness in this epileptic population both in terms of costs and of quality of life. Costs and quality of life will be also compared between the two populations.