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Epilepsy clinical trials

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NCT ID: NCT01393743 Completed - Clinical trials for Seizure Disorder Generalized Tonic Clonic

A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures

Start date: September 2011
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of perampanel on Primary Generalized Tonic Clonic (PGTC) seizure frequency in adolescents and adults maintained on one to two stable antiepileptic drugs.

NCT ID: NCT01392768 Completed - Epilepsy Clinical Trials

Efficacy and Safety of Levetiracetam in Partial Seizures Control, With or Without Secondary Generalization

Mozart
Start date: January 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether levetiracetam as adjunctive therapy is effective in the treatment of partial seizures, with or without secondary generalization, associated with refractory focal epilepsy.

NCT ID: NCT01390909 Completed - Epilepsy Clinical Trials

Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database

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

Antiepileptic drugs (AEDs) are the main therapeutic option for patients with epilepsy; however, complete seizure control remains elusive for many patients. Uncontrolled or refractory epilepsy is associated with a higher risk of mortality, physical injuries, and depression or anxiety compared with patients with controlled epilepsy. Higher resource utilization for patients with poor control is likely to be associated with higher economic costs. While diagnostic criteria for uncontrolled epilepsy are debated by neurologists, recent studies suggest that a diagnosis of uncontrolled epilepsy requires 1.) at least one seizure per month and 2.) a history of drug failures. The objective of this study is to identify patients with uncontrolled epilepsy in both a Medicaid database and a private health plan database, to describe patient characteristics and AED treatment patterns between cohorts of patients with uncontrolled versus well-controlled epilepsy, and to evaluate the economic burden of uncontrolled versus well-controlled epilepsy. For this evaluation, the data sources are medical and pharmacy claims in Medicaid databases from Florida (Third quarter 1997 to second quarter 2008), Iowa (First quarter 1998 to second quarter 2006), Kansas (First quarter 2001 to second quarter 2009), Missouri (First quarter 1997 to second quarter 2008) and New Jersey (First quarter 1997 to fourth quarter 2008) and medical and pharmacy claims in an private health plan database. The study design is a retrospective, longitudinal, matched-cohort study. Eligible patient records will be assigned to one of three mutually-exclusive cohorts: uncontrolled epilepsy (at least 2 consecutive changes in AED therapy in at least 30 days, and at least 1 epilepsy-related inpatient or emergency department (ED) visit within 365 days), well-controlled epilepsy (no AED changes and no epilepsy-related inpatient or ED visits), and intermediate epilepsy (not classified as uncontrolled or well-controlled).

NCT ID: NCT01376180 Completed - Epilepsy Clinical Trials

Drug Use Investigation for LAMICTAL

Start date: December 2008
Phase: N/A
Study type: Observational

The purpose of this study is to grasp actual status of usage of lamotrigine tablet and to collect information for using lamotrigine tablet effectively and safely as well as to grasp onset status of adverse events in pediatric subjects, geriatric subjects, pregnant women, subjects with poor renal and hepatic functions.

NCT ID: NCT01374204 Completed - Epilepsy Clinical Trials

Epilepsy-Associated Stigma

EPISTIGMA
Start date: July 2011
Phase:
Study type: Observational

Few data about epilepsy-associated stigma in France are available. The only study we have found showed that in France 66% of people with epilepsy felt stigmatized by their condition and are often single, compared with the other European patients interviewed (Baker et al., 2000). The purpose of this study is to assess the association between type of epilepsy (drug resistant-epilepsy and stabilized epilepsy) and perceived stigma (using the Stigma Scale) in patients recruited in the Limousin region .

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: NCT01364597 Completed - Epilepsy Clinical Trials

Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy

Start date: August 1, 2011
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects with epilepsy.

NCT ID: NCT01364558 Completed - Epilepsy Clinical Trials

A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers

Start date: February 2011
Phase: Phase 1
Study type: Interventional

The purpose of this clinical research study is to assess the bioavailability and pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and injectable diazepam after intravenous (I.V.) administration

NCT ID: NCT01357902 Completed - Epilepsy Clinical Trials

Lamotrigine Bioequivalence Study to Compare Dispersible Tables With Compressed Tablets in China

Start date: April 18, 2011
Phase: Phase 1
Study type: Interventional

It is an open-label, randomised, single dose, two-sequence cross-over study. Twenty-four eligible, healthy, Chinese male subjects will be enrolled after providing written informed consent. Subjects will be randomised into two treatment groups 1 day prior to the first dosing day and will be assigned to regimen sequences (AB or BA) in a balanced fashion in accordance with the randomisation schedule. Regimen A is five lamotrigine 5 mg chewable/dispersible tablets and Regimen B is one lamotrigine 25 mg standard/compressed tablet. Subjects will receive their allocated regimen on the morning of Day 1 and will undergo study assessments for 7 days (until Day 8). Subjects will receive their alternate randomised treatment after a washout period of 14-21 days from Day 1. Subjects will undergo a further assessment period of 7 days and will attend a follow-up visit during 8-12 days after the second treatment. The total observation period in this study will be 23~34 days. Subjects will arrive at the research unit on the evening before each lamotrigine dosing occasion and will remain in the unit until the 24-h post-dose evaluations have been completed (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 h). After this, subjects will return home but must return to the unit for further assessments to be made at 36, 48, 72, 96, 120, 144 and 168 h after dosing Study Endpoints/Assessments A total of 19 serial blood samples (5 mL each) will be collected for the measurement of plasma lamotrigine concentrations at each study assessment. Safety and tolerability assessments (monitoring of adverse events and serious adverse events, routine laboratory determinations, vital sign measurements and 12-lead electrocardiogram) will be conducted throughout the study.

NCT ID: NCT01357707 Completed - Epilepsy Clinical Trials

Clinical-genetic Investigations in Children With Early Infantile Epilepsies

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

The project strives to discover novel genetic defects that cause monogenic epilepsy or that genetically modify a preexisting epileptic phenotype. Our main aim is to find genetic causes for the idiopathic West Syndrome (infantile seizures) that are not caused by known cerebral malformation, lissencephaly or metabolic disorders and which have a comparatively benign prognosis. The investigators hypothesize that mutations in genes coding for ion channels or genes that modify the action of ion channels might be causative. For that the investigators will perform a sequence analysis of the coding exons of a large set of genes in all recruited patients and verify found mutations in their parents.