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NCT01891890 · ClinicalTrials.gov registry record · Phase 3
Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)
A Phase 3 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 72
- Enrollment target
NCT01891890 is a Phase 3 study that was terminated before completion, run by Emory University. The registered enrollment target is 72 participants.
The verdict
NCT01891890, a Phase 3 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 72 participants
- Enrollment target
Study 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 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.
Interventions
- DRUG Lamotrigine
- DRUG Levetiracetam
- DRUG Oxcarbazepine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-10-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01891890
The ClinicalTrials.gov registry entry for NCT01891890 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Lamotrigine is the first listed.
NCT01891890 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01891890 about?
NCT01891890 is a clinical study titled "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 concent...
What is the current status of trial NCT01891890?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2013-08. Estimated completion is 2015-10-23.
What interventions are being tested in trial NCT01891890?
The interventions under investigation include: Lamotrigine (DRUG), Levetiracetam (DRUG), Oxcarbazepine (DRUG).
Who is sponsoring clinical trial NCT01891890?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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