Ignite Creation Date:
2024-05-06 @ 1:45 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01891890
Status:
TERMINATED
Last Update Posted:
2017-09-19
First Post:
2013-06-28
Brief Title:
Cognitive AED Outcomes in Pediatric Localization Related Epilepsy COPE
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Cognitive AED Outcomes in Pediatric Localization Related Epilepsy COPE
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE
Brief Summary:
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 childs 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 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PCORI 527 | OTHER_GRANT | PCORI | None |