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 |
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| Completed |
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Phase 3 | |
| Completed |
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| Completed |
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| Completed |
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| Completed |
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| Terminated |
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N/A | |
| Completed |
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Phase 2 | |
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Phase 4 | |
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Phase 2 |