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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: Clinical Trial Phase 3 study, sponsored by Emory University.
NCT01891890 is a Phase 3 study that was terminated before completion, run by Emory University. The registered enrollment target is 72 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Conners' Continuous Performance Test II (CPT-II) is a measure of sustained attention. Letters are individually presented on a computer screen, and participants are instructed to press the space bar when they are presented with any letter except the letter "X". For children younger than 6 years of age at enrollment, the Kiddie CPT will be used in which the child is instructed to press the space bar every time the ball appears on the screen. The outcome measure is a confidence index representi
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 |
Why NCT01891890 stopped before completion
NCT01891890 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which Lamotrigine is the first listed.
NCT01891890 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01891890's enrollment target sits among peer trials
72 1780th of 2000 higher than 217 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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