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Epilepsies, Partial clinical trials

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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: NCT01375374 Terminated - Epilepsy, Partial Clinical Trials

Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide

VICTOR
Start date: July 2011
Phase: Phase 3
Study type: Interventional

The purpose of the trial is to investigate whether changes in lipids and hormonal parameters can be observed in blood when Carbamazepine treatment is replaced with Lacosamide treatment, while Levetiracetam treatment remains unchanged.

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.

NCT ID: NCT01313260 Recruiting - Epilepsies Clinical Trials

Structural and Functional Connectivity in Partial Epilepsies Studied With MRI and MEG

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

Surgery may be an effective therapy for refractory focal epilepsies with a clear delineated focus but surgical benefits are less clear for patients with a poorly defined focus such as non lesional refractory partial epilepsies. SEEG is considered the criterion standard to localize the epileptogenic zone (EZ) but the procedure is risky with a limited spatial sampling. The development of non-invasive neuroimaging alternatives is thus an important goal to improve EZ delineation and optimize SEEG procedures. The main hypothesis of this research project is the existence of a network organization specific for each patient which allows the generation and propagation of epileptic activities. The investigators wish to explore this network using diffusion tensor MRI to study structural connectivity and MEG/FMRI to study functional connectivity. The investigators will apply tools from the theories of complex networks and dynamical systems to characterize the network organization of epileptic process. The investigators aimed to identify and localize differences in connectivity parameters between individual patients and a control group of healthy volunteers.

NCT ID: NCT01311440 Completed - Epilepsy Clinical Trials

Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

Start date: March 2011
Phase: N/A
Study type: Interventional

In Oslo University Hospital, department of complex epilepsy, offer ketogenic diet to treat children with medically intractable epilepsy. From 2009 we added modified Atkins diet as a treatment option for children up to 18 years. We now initiate an open, prospective, randomized and controlled study with the aim to test the efficacy of treatment with modified Atkins diet in adults with focal and generalized epilepsy diagnoses, in order to evaluate whether this treatment should be offered to patients on a permanent basis.

NCT ID: NCT01281956 Terminated - Epilepsy Clinical Trials

PRX-00023 Therapy in Localization-Related Epilepsy

Start date: January 7, 2011
Phase: Phase 2
Study type: Interventional

Background: - The brain chemical serotonin helps nerve cells communicate. Previous research suggests that serotonin activity may be lower in brain areas where seizures start, and that increasing activity at the serotonin receptor site on nerve cells may help prevent seizures. Researchers are interested in determining whether the experimental medication PRX-00023, which increases the activity of serotonin receptors, can reduce seizure frequency in people whose seizures are not well-controlled on antiseizure medication. PRX-00023 has not previously been studied in people with epilepsy and has not previously been given to people taking antiseizure medication at the same time. Objectives: - To evaluate the effectiveness of PRX-00023 in reducing the frequency of epileptic seizures that start from only one part of the brain. Eligibility: - Individuals between 18 and 65 years of age who have frequent epileptic seizures even after trying at least two different standard anti-seizure medications (either at the same time or one after the other). Design: - The study requires 9 outpatient visits to the NIH Clinical Center over a 34-week period. Individuals who choose to participate in additional studies may be an inpatient during some of these visits. - Participants will be screened with a medical history and physical examination, blood and urine samples, ECG, EEG, neuropsychological studies, imaging studies, including PET and MRI scans - Participants will have a 6-week observation and evaluation period before starting the study medication. Participants who have at least four seizures during this period will be eligible for the treatment portion of the study. - All participants will receive either PRX-00023 or a placebo pill twice daily for 12 weeks, and will have regular clinic visits with blood samples and imaging studies. - After the 12-week period, participants will have a 2- to 3-week washout period without any study medication. - Participants will then have another study medication period, and will receive the opposite pill (PRX-00023 or placebo) from the one taken in the first treatment phase. Participants will continue to have regular clinic visits with blood samples, ECG, EEG and neuropsychologicalstudies. - One month after the end of the second study medication phase, participants will have a followup evaluation with a physical examination, blood tests, ECG, EEG, mood and neuropsychological tests. Outcome measures: The primary outcome measure for drug efficacy will be: Mean difference in seizure frequency comparing the active and placebo periods. Secondary outcome measures for efficacy will be: Proportion of patients with greater than or equal to 50% lower seizure rate on PRX-00023 than placebo Hamilton Depression and Anxiety Rating scales Performance on mood and neuropsychological testing scales

NCT ID: NCT01273129 Recruiting - Epilepsy Clinical Trials

Surgery as a Treatment for Medically Intractable Epilepsy

Start date: March 21, 2011
Phase:
Study type: Observational

Background: - Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery. The tests and surgery performed as part of this treatment are not experimental, but researchers are interested in using the data collected as part of routine standard epilepsy care to better understand epilepsy and its treatment. Objectives: - To use surgery as a treatment for drug resistant epilepsy in children and adults. Eligibility: - Children and adults at least 8 years of age who have simple or complex partial seizures (seizures that come from one area of the brain) that have not responded to medication, and who are willing to have brain surgery to treat their medically intractable epilepsy. Design: - Participants will be screened with a medical history, physical examination, and neurological examination. Imaging studies, including magnetic resonance imaging and computer-assisted tomography (CT), may also be conducted as part of the screening. Participants who do not need surgery or whose epilepsy cannot be treated surgically will follow up with a primary care physician or neurologist and will not need to return to the National Institutes of Health for this study. - Prior to the surgery, participants will have the following procedures to provide information on the correct surgical approach. - Video electroencephalography monitoring to measure brain activity during normal activities within a 24-hour period. Three to four 15-minute breaks are allowed within this period. - Electrodes placed directly in the brain or on the surface of the brain to measure brain activities and determine the part of the brain that is responsible for the seizures (seizure focus). - Participants will have a surgical procedure at the site of their seizure focus. Brain lesions, abnormal blood vessels, tumors, infections, or other areas of brain abnormality will be either removed or treated in a way that will stop or help prevent the spread of seizures without affecting irreplaceable brain functions, such as the ability to speak, understand, move, feel, or see. - Participants will return for outpatient visits and brain imaging studies 2 months, 1 year, and 2 years after surgery.

NCT ID: NCT01262677 Completed - Epilepsies, Partial Clinical Trials

Once-A-Day Pregabalin For Partial Seizures

Start date: February 17, 2011
Phase: Phase 3
Study type: Interventional

Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.

NCT ID: NCT01235403 Completed - Partial Epilepsies Clinical Trials

Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure

SELF
Start date: June 2010
Phase: Phase 4
Study type: Interventional

To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy. Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility