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Epilepsies, Partial clinical trials

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NCT ID: NCT01724918 Terminated - Focal Epilepsy Clinical Trials

Lacosamide IV and EEG/EKG (LIVE) Study

LIVE
Start date: May 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of different intravenous doses (IV) of a new anti-epileptic drug (AED) called lacosamide on continuous EEG (electroencephalogram) rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those doses by patients. In addition, this study will assess the effect of IV lacosamide on EKG (electrocardiogram), a test which checks for problems with the electrical activity of the heart.

NCT ID: NCT01545518 Terminated - Seizure Disorder Clinical Trials

IVIG Treatment for Refractory Immune-Related Adult Epilepsy

Start date: November 2011
Phase: Phase 2
Study type: Interventional

The purpose of the initial screening study is to find out if immune problems are an unrecognized cause of epilepsy in some patients. This study consists of a single blood sample, which will be tested for possible immune abnormalities. If enough patients are found who show immune abnormalities, those patients who are still having uncontrolled seizures will be invited to participate in a study of immune treatment with a compound called intravenous immunoglobulin (IVIG). The study hypothesis is that a significant proportion of the young-onset, refractory, image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and many of these patients will respond to immune therapies, including IVIG. At present, the importance of immune abnormalities in causing epilepsy, and the proper treatment when they are found, are both poorly understood. The investigators hope that this study will help us understand the cause of some cases that are difficult to treat.

NCT ID: NCT01501383 Terminated - Epilepsy Clinical Trials

A Study to Evaluate the Efficacy and Safety of VX-765 in Subjects With Treatment-Resistant Partial Epilepsy

Start date: December 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and tolerability of VX-765 in subjects with treatment-resistant partial epilepsy.

NCT ID: NCT01496612 Terminated - Depression Clinical Trials

Buspirone Therapy for Localized Epilepsy

Start date: November 22, 2011
Phase: Phase 2
Study type: Interventional

Background: Buspirone is a drug that is approved for the treatment of anxiety in adults. Studies suggest that buspirone might act on parts of the brain that can increase certain levels of brain activity. Increasing this brain activity may help decrease epileptic seizures that come from certain parts of the brain. Researchers want to see if buspirone can reduce seizure frequency in people with seizures who are already taking antiseizure medication. Objectives: To test whether buspirone can reduce the frequency of seizures in people whose seizures seem to start from one part of the brain. Eligibility: Individuals between 18 and 65 years of age who have seizures coming from one or more places in the brain. Participants must have tried at least two different antiseizure medications. Participants must also have had at least three seizures during a 1-month observation period while on current medicines. Design: Participants will have a screening visit with a physical exam and medical history. Participants will complete mood and memory testing scales. Blood, urine, and saliva samples will be collected. Participants will have a magnetic resonance imaging scan to evaluate brain structures that relate to epilepsy. They will also have a positron emission tomography scan to look at parts of the brain that are affected by buspirone. Participants will start taking a study drug (either buspirone or placebo) twice daily. They will keep a calendar of seizures and record any side effects. Treatment will be monitored with clinic visits and blood samples. After 12 weeks on the study drug, participants will gradually stop taking either the placebo or buspirone over two weeks. They will stay off the drug for another 2 weeks. After 2 weeks, participants will start taking a study drug that is the opposite of the one they had before. They will keep a calendar of seizures and record any side effects. Treatment will be monitored with clinic visits and blood samples. After 12 weeks on the study drug, participants will gradually stop taking either the placebo or buspirone. Participants will have a final followup visit with additional blood tests, mood and memory testing scales and imaging studies.

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: 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: NCT01128712 Terminated - Clinical trials for Epilepsy, Complex Partial

Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin

Start date: April 2010
Phase: Phase 4
Study type: Interventional

To prospectively demonstrate the superior anxiolytic effect of high dose pregabalin (PGB) therapy (450 mg/day) compared to low dose PGB therapy (150 mg/day) in subjects with medically refractory partial epilepsy not fully controlled despite treatment with 1-2 concomitant antiepileptic drugs (AEDs).

NCT ID: NCT00524030 Terminated - Epilepsies, Partial Clinical Trials

Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

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

This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.

NCT ID: NCT00522418 Terminated - Epilepsy Clinical Trials

Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients

Start date: February 2006
Phase: Phase 4
Study type: Interventional

This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy.

NCT ID: NCT00391534 Terminated - Partial Epilepsy Clinical Trials

EXTENT: EXtended Tolerability and Efficacy of a Novel Formulation of Oxcarbazepine in a Trial in Partial Epilepsy

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

This study is intended to investigate the safety and efficacy of a novel formulation of oxcarbazepine that is released more slowly than the current formulation. The study medication will be used as a treatment against partial epilepsy.