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Terminated Phase 3 Interventional Results available

Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)

ClinicalTrials.gov ID: NCT01891890

Public ClinicalTrials.gov record NCT01891890. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 10:25 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01891890
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Emory University
Other
Enrollment
72 participants

Conditions and interventions

Eligibility (public fields only)

Age range
5 Years to 16 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2013 (Type not available)
Primary completion
Oct 23, 2015 (Actual)
Completion
Oct 23, 2015 (Actual)
Last update posted
Sep 19, 2017

2013 – 2015

United States locations

U.S. sites
14
U.S. states
13
U.S. cities
14
Facility City State ZIP Site status
Arkansas Children's Hospital Little Rock Arkansas 72205 —
University of California at San Diego San Diego California 92092 —
Children's Hospital Colorado Aurora Colorado 80045 —
Children's National Medical Center Washington D.C. District of Columbia 20010 —
Children's Healtcare of Atlanta Atlanta Georgia 30342 —
Johns Hopkins University Baltimore Maryland 21287 —
Boston Children's Hospital Boston Massachusetts 02115 —
Washington University St Louis Missouri 63110 —
University of Rochester Monroe New York 14642 —
Cincinnati Children's Hospital Cincinnati Ohio 45229 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Le Bonheur Children's Hospital Memphis Tennessee 38105 —
Eastern Virginia Medical School Norfolk Virginia 23510 —
Virginia Commonwealth University Richmond Virginia 23284 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01891890, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 19, 2017 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01891890 live on ClinicalTrials.gov.

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