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Epilepsy clinical trials

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NCT ID: NCT00347152 Completed - Epilepsy Clinical Trials

Comparison of Immediate vs Gradual Switch to Divalproex in Adults With Intellectual Disability

Start date: November 2006
Phase: N/A
Study type: Interventional

The 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.

NCT ID: NCT00345475 Completed - Epilepsy Clinical Trials

UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)

Start date: December 2004
Phase: Phase 4
Study type: Observational

This is a prospective, observational, exposure-registration and follow-up study of women and their offspring exposed to Keppra® (levetiracetam) and Keppra XR® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The UCB AED Pregnancy Registry is designed to monitor pregnancies exposed to Keppra® and Keppra XR® in order to determine if there is a potential increase in the risk of major birth defects compared to rates from women in the general US population. The objectives of the UCB AED Pregnancy Registry are: - To prospectively collect data concerning 1) exposure to Keppra® and Keppra XR® during pregnancy, 2) potential confounding factors, 3) outcome of pregnancy, and 4) long-term pediatric outcome - To review reported cases of possible birth defects - To estimate the risk of birth defects occurring in live-born offspring of women exposed to Keppra® and Keppra XR® during pregnancy This study is being conducted in the United States (US). Enrollment in the Registry is voluntary. The UCB AED Pregnancy Registry is sponsored by UCB, Inc. and is managed by INC Research. The scientific conduct and analysis of the Registry is overseen by an Expert Panel consisting of external specialists in teratology/genetics, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).

NCT ID: NCT00344877 Completed - Clinical trials for Temporal Lobe Epilepsy

Electrical Brain Stimulation to Reduce Epileptic Seizures

Start date: June 19, 2006
Phase: N/A
Study type: Observational

OBJECTIVES: About 15% of patients suffering from focal epilepsy are refractory to available pharmacological treatments. Until now, the only hope for such patients has been the development of new pharmaceutical treatments or epilepsy surgery. In case of inoperability, different types of invasive brain stimulation such as vagus nerve stimulation or deep brain stimulation or non-invasive repetitive TMS have been evaluated to determine their anticonvulsive potential. For rTMS, weak and short lasting seizure reduction has been reported in different epilepsy syndromes. A new, non-invasive stimulation technique, transcranial direct current stimulation (tDCS), was useful to modulate cortical excitability in many cortical areas (M1, visual cortex, frontal cortex). Cathodal tDCS, with a current of 1 mA, induced long-term depression in animal models and reportedly decreased the excitability of both human and animal cerebral cortex. In epilepsy patients suffering from a malformation of cortical development, a single session of cathodal tDCS helped reduce seizures briefly. The purpose of this protocol is to study the effects of repeated applications of tDCS on the excitability of the seizure focus in patients with poorly controlled pharmacologically refractory temporal lobe epilepsy. STUDY POPULATION: We plan to study 56 patients between the ages of 18 and 80 suffering from temporal lobe epilepsy. DESIGN: Subjects will be allocated by blocked randomization to one of two groups (parallel design). Group A will receive cathodal tDCS and group B will receive Sham-tDCS on five consecutive days. Each subject will participate in 9 sessions (1 baseline visit, 5 intervention visits, 3 follow-up visits). The effect of the intervention relative to the sham stimulation will be evaluated by comparing seizure frequency and neuropsychological tests during the 8 weeks before and after the intervention. OUTCOME MEASURES: Primary outcome measure will be the mean seizure frequency per 4 weeks in the tDCS group as compared to the Sham-tDCS group. To analyze the effect of the intervention (tDCS), seizures will be evaluated during a 2x4 week baseline period before tDCS and 2x4 weeks after the intervention. Using these data we will calculate the percentage change of seizures per 4 weeks. Secondary outcome measures will be the scores of the neuropsychological testing (HVLT-R, BVMT-R, CTMT, COWAT) and number of epileptiform discharges in the EEG. Furthermore, th...

NCT ID: NCT00334958 Completed - Epilepsy Clinical Trials

Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures

Start date: February 13, 2006
Phase: Phase 3
Study type: Interventional

To evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult participants (12 to 80 years, inclusive) with refractory partial onset seizures maintained on a maximum of 3 stable antiepileptic drugs (AEDs).

NCT ID: NCT00323947 Completed - Epilepsy Clinical Trials

Methylphenidate for Treating Attention Deficit Hyperactivity Disorder in Children With Both ADHD and Epilepsy

Start date: May 2003
Phase: Phase 4
Study type: Interventional

This study will evaluate the safety and effectiveness of extended release methylphenidate (XR-MPH) in treating attention deficit hyperactivity disorder (ADHD) in children with both ADHD and epilepsy.

NCT ID: NCT00319605 Completed - Epilepsy Clinical Trials

Cross Sectional Study to Evaluate the Acceptability of Oral Solution of Levetiracetam

Start date: April 2006
Phase: Phase 4
Study type: Observational

Phase IV, observational, post-authorization, cross sectional, open-label, multicenter study to evaluate the acceptability of oral solution of levetiracetam in patients with partial epilepsy as assessed by a questionnaire.

NCT ID: NCT00319501 Completed - Epilepsy Clinical Trials

Efficacy and Safety of Vanquix for the Management of Selected, Refractory, Patients With Epilepsy Who Require Intermittent Caregiver Medical Intervention to Control Episodes of Acute Repetitive Seizures.

Start date: January 2006
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of Vanquix for the management of selected, refractory, patients with epilepsy who require intermittent medical intervention provided by caregivers who are not health care professionals, and who are not under the direct supervision of a healthcare professional at the time of administration to control episodes of acute repetitive seizures (ARS).

NCT ID: NCT00318929 Completed - Epilepsy Clinical Trials

Tolerability and Efficacy of Depakote-extended Release in the Elderly

Start date: April 2006
Phase: N/A
Study type: Interventional

There is a bimodal distribution to the new onset seizures with one peak occurring in the very young and the second peak occurring in persons over age 65 years. The presentation of seizures in the elderly may vary from that of younger patients and the diagnosis may be confused with other conditions such as transient ischemic attacks. However, the consequences of epilepsy in the elderly can be severe leading to impaired cognition, increased falls, and a decreased quality of life. The treatment of epilepsy may be complicated by pharmacokinetic and pharmacodynamic changes occurring in the elderly.

NCT ID: NCT00310375 Completed - Epilepsy Clinical Trials

Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial

Start date: May 1, 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.

NCT ID: NCT00302991 Completed - Epilepsy Clinical Trials

Quality of Life and Adverse Effects in Epilepsy Patients (EPIKA)

Start date: March 2006
Phase: Phase 4
Study type: Observational

Observational, multicentre, epidemiological study to determine the HRQOL of patients with epilepsy according to treatment sub-group and to validate the Spanish version of the Adverse Events Profile, produced by G. Baker et al. Three treatment groups will be examined: patients receiving only a new anti-epilepsy drug (AED), patients receiving a "classic" AED; patients receiving combination therapy.