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Epilepsy clinical trials

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NCT ID: NCT01064297 Completed - Epilepsy Clinical Trials

Lamotrigine Pregnancy Registry (LAM05)

Start date: November 2001
Phase: N/A
Study type: Observational

Antiepileptic drugs (AEDs) are not indicated for use in pregnancy. However, women with epilepsy, and other approved indications including bipolar disorder, may require or be unintentionally exposed to AEDs during pregnancy. Prior to an AED being marketed there are few data available on drug safety in pregnancy: data from animal models may not translate directly to humans and pregnant women are routinely excluded from clinical trials. The International Lamotrigine Pregnancy Registry was established by GlaxoSmithKline (GSK) in 1992 to monitor the safety of lamotrigine during pregnancy.

NCT ID: NCT01063764 Completed - Epilepsy Clinical Trials

An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures

Start date: January 2010
Phase: Phase 3
Study type: Interventional

Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).

NCT ID: NCT01061866 Completed - Refractory Epilepsy Clinical Trials

Thalidomide Low Threshold in Epilepsy

Start date: June 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether thalidomide is effective in the refractory epilepsy treatment.

NCT ID: NCT01060228 Completed - Schizophrenia Clinical Trials

A Drug Interaction Study of Valproic Acid and Single-dose Paliperidone Extended-Release (ER) in Healthy Men

Start date: January 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of valproic acid (VPA) on the pharmacokinetics (blood levels) of a single oral dose of an extended-release formulation of paliperidone in healthy male volunteers.

NCT ID: NCT01055327 Completed - Epilepsy Clinical Trials

Birth Defects Associated With Exposure to Lamotrigine in Pregnancy (EUROCAT)

Start date: May 2009
Phase: N/A
Study type: Observational

In 2007 a case control study was completed within the EUROCAT European network of congenital anomaly registers to test the hypothesis that first trimester lamotrigine monotherapy exposure is associated with an increased risk of isolated oral clefts. This study found no statistically significant increased risk of oral clefts compared with other defects following lamotrigine exposure in the uterus. The EUROCAT Antiepileptic Drug (AED) Database, established for the original case control study in 2007, will now be expanded to include an additional five to six years worth of data. These data will provide greater power to investigate the risk of isolated oral clefts, specific cleft types and potential associations with additional specific malformation types (e.g. neural tube defects). Data on cases of isolated oral clefts registered between 1993 and 2012 will be extracted from EUROCAT member registers meeting set inclusion criteria (ensuring completeness of outcome and exposure data). The primary comparison group will include all non oral cleft, non chromosomal malformations as the registers do not collect data on non malformed infants. This study will also be powered to include a second control group of chromosomal malformations, very unlikely to be associated with medication exposure. Data on exposure to anti-epileptic drugs (AEDs) during the first trimester of pregnancy will be extracted along with other key covariates including age of mother, history of epilepsy and gestational age of the infant. Primary analyses, using logistic regression, will compare the lamotrigine monotherapy versus no AED use across case and control groups and a secondary analysis will compare lamotrigine monotherapy versus other AED monotherapy (with and without valproate). Data will also be monitored for patterns of lamotrigine exposure across additional specific malformation groups of interest.

NCT ID: NCT01054599 Completed - Epilepsy Clinical Trials

Does Memantine Improve Verbal Memory Task Performance in Subjects With Partial Epilepsy and Memory Dysfunction?

Start date: January 2009
Phase: N/A
Study type: Interventional

Many patients with epilepsy have memory deficits in the setting of otherwise normal intelligence. Unfortunately, the treatment options for memory dysfunction in patients with epilepsy are limited. The investigators are conducting a study to evaluate the effects of memantine for the treatment of verbal memory dysfunction in subjects with localization-related seizures. The study involves randomization to memantine therapy or placebo, with cognitive testing and EEG pre- and post-treatment, as well as after an open-label memantine treatment phase. The primary aim of this study is to evaluate the efficacy of memantine for the treatment of verbal memory dysfunction in subjects with left temporal lobe epilepsy. The investigators expect that verbal memory task performance will improve in those taking memantine, but not in those taking a placebo. The investigators propose that the expected benefit of memantine is specific to verbal memory in subjects with left temporal lobe seizures, rather than representing an overall improvement in cognitive function. The investigators expect no improvement on other cognitive tasks in either the memantine or placebo groups. The investigators will evaluate whether subjects with left temporal lobe epilepsy and memory difficulties have self-reported improvement in memory while taking memantine. The investigators expect improvement of self-rated memory function on the Quality of Life in Epilepsy Patient Inventory (QOLIE-89) in the memantine group, but no change on this scale in the placebo group.

NCT ID: NCT01048255 Completed - Partial Epilepsy Clinical Trials

Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy

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

The purpose of this study is to determine the safety, tolerability, and efficacy of VX-765 in subjects with Treatment-resistant Partial Epilepsy

NCT ID: NCT01030094 Completed - Epilepsy Clinical Trials

A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy

Start date: February 2007
Phase: Phase 4
Study type: Observational

The purpose of this study is to investigate the influence of topiramate monotherapy on the bone and mineral metabolism markers, and bone density (the amount of mineral per square centimeter of bone ) in female participants with epilepsy (seizure disorder), before menopause (time in life when a woman stops having a menstrual period), as compared with healthy participants and comparative group received either carbamazepine or valproic acid monotherapy for at least last one year.

NCT ID: NCT00991757 Completed - Epilepsy Clinical Trials

An Open-Label Extension Study to Evaluate the Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Patients 16 Years and Older With Partial Onset Seizures.

Start date: February 2007
Phase: Phase 3
Study type: Interventional

The purpose of this open-label extension study is to demonstrate that RWJ-333369 is safe as long-term add-on treatment of partial onset seizures.

NCT ID: NCT00988429 Completed - Partial Epilepsy Clinical Trials

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures

Start date: December 2, 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Eslicarbazepine acetate (BIA 2-093) is an effective adjunct therapy in the treatment of refractory partial seizures