Epilepsy, Partial Clinical Trial
Official title:
Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)
Seizures that arise in specific areas in the brain are called Localization Related Epilepsy
(LRE) and are the most common seizure disorder in children. Children that receive drug
treatment for this disorder may suffer from treatment related side effects which impact their
ability to think or concentrate and their ability to interact socially. These negative
treatment effects can impact the child's performance in school and long term may impact
employment and job options.
This study will determine whether changes in attention and social interactions are seen in
children treated for LRE using three of the most common medications used to treat pediatric
LRE. Children who are newly diagnosed with LRE by their doctors and are between the ages of 5
years 6 months and 16 years 0 months will be randomized to receive levetiracetam,
lamotrigine, or oxcarbazepine.
There will be 14 study sites throughout the US. Children will undergo evaluation of their
thinking and ability to pay attention before and after starting drug treatment for LRE.
Regardless of the specific findings, results of this study will provide the information
needed to help parents and their clinicians choose treatment options that maximize cognitive
abilities in children with LRE, and provide the data needed for practice guidelines to be
established on the basis of cognitive side effect risks.
This is a prospective multicenter, randomized, open-label, central assessor, parallel-group
study of children ages 5 years, 6 months to 16 years, 0 months with newly diagnosed
Localization Related Epilepsy (LRE) to establish whether three common antiepileptic drugs
(AEDs) used as first line LRE treatment (lamotrigine (LTG), levetiracetam (LEV), or
oxcarbazepine (OXC)) are associated with differential cognitive side effects on attention. It
is predicted that one AED will be identified with greater negative cognitive effects on
attention. The study will also examine whether there are differential risks for drug-related
behavior change. The study will address whether 6 month attentional outcomes can be reliably
predicted based upon shorter term cognitive change assessed soon after beginning AED therapy,
and establish practice effects associated with repeated test exposure when on constant doses
of AED.
Children will undergo cognitive testing after study enrollment and no more than a week after
AED initiation. Selected measures will be repeated at the first follow up clinic visit after
beginning AED treatment, and the primary endpoint will be the attention performance obtained
at the subjects' 6 month follow-up clinic visit.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00105040 -
A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures
|
Phase 2 | |
| Completed |
NCT00160615 -
Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method
|
Phase 3 | |
| Completed |
NCT00152516 -
Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures
|
Phase 3 | |
| Completed |
NCT00175890 -
A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.
|
Phase 3 | |
| Completed |
NCT00113165 -
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
|
Phase 3 | |
| Withdrawn |
NCT01691872 -
Pharmacokinetic Study of Retigabine Extended Release (XR) Formulation in Healthy Adult Japanese and Caucasian Subjects
|
Phase 1 | |
| Completed |
NCT00160654 -
Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy
|
Phase 4 | |
| Terminated |
NCT01545518 -
IVIG Treatment for Refractory Immune-Related Adult Epilepsy
|
Phase 2 | |
| Completed |
NCT00141414 -
To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.
|
Phase 2 | |
| Completed |
NCT01332539 -
An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy
|
N/A | |
| Completed |
NCT00355082 -
Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy
|
Phase 3 | |
| Completed |
NCT00152451 -
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
|
Phase 2 | |
| Withdrawn |
NCT02220972 -
To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset Seizures
|
Phase 4 | |
| Completed |
NCT00160628 -
Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy
|
Phase 3 | |
| Completed |
NCT00245713 -
Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy.
|
Phase 4 | |
| Terminated |
NCT01375374 -
Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide
|
Phase 3 | |
| Completed |
NCT00152373 -
Double-blind, Placebo-controlled Study of Levetiracetam in Adults With POS
|
Phase 3 | |
| Completed |
NCT00150709 -
A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy
|
Phase 3 | |
| Completed |
NCT00643500 -
Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy
|
Phase 4 | |
| Completed |
NCT00152503 -
Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
|
Phase 2 |