Overview

This trial is active, not recruiting.

Conditions epilepsy, partial, epilepsy, localization related, adverse effects
Treatments oxcarbazepine, levetiracetam, lamotrigine
Phase phase 3
Sponsor Emory University
Collaborator Patient-Centered Outcomes Research Institute
Start date August 2013
End date April 2017
Trial size 78 participants
Trial identifier NCT01891890, IRB00066541, PCORI 527

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 6-12 years of age will be randomized to receive levetiracetam, lamotrigine, or oxcarbazepine.

There will be 12 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
lamotrigine 7.0 mg/kg tablets or chewable tablets administered daily in 2 equally divided doses
lamotrigine Lamictal
Titration to target dose starting at week 11. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks.
(Active Comparator)
oxcarbazepine 25 mg/kg tablets or liquid administered daily in 2 equally divided doses
oxcarbazepine Trileptal
Titration to target dose starting at week 3. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks.
(Active Comparator)
levetiracetam 30 mg/kg tablet or liquid administered daily in 2 equally divided doses
levetiracetam Keppra
Titration to target dose starting at week 3. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks.

Primary Outcomes

Measure
Conners' Continuous Performance Test (CPT) Confidence Interval
time frame: 6 months

Secondary Outcomes

Measure
Child Behavior Checklist
time frame: 6 months

Eligibility Criteria

Male or female participants from 5 years up to 16 years old.

Inclusion Criteria: - Age of participant between 5 years, 6 months and 16 years, 0 months at the time of enrollment - Weight is between ≥ 15 kg the lower limit BMI 99th percentile at study entry at study entry - Child has a diagnosis of Localization Related Epilepsy (LRE) with or without secondary generalization according to International League Against Epilepsy (ILAE) criteria and which may include Benign Rolandic Epilepsy and Benign Occipital Epilepsy or other LREs. - Localization related seizures will be based upon at least one of the following: 1) focal EEG abnormalities (sharp waves, spikes, or slowing) and the absence of generalized spike waves discharges, 2) focal MRI abnormalities other than active cysticercosis, which may include temporal lobe sclerosis, dysembryoplastic neuroepithelial tumor , ganglioglioma, or focal malformations of cortical development, 3) focal neurologic abnormalities, or 4) clinical semiology, which may include Todd's phenomenon, unilateral dystonia, or fencing posture, or distinct aura consistent with localization related seizure onset (e.g., classic déjà vu or bad smell). - Participants must either be AED therapy naïve or on an AED (excluding benzodiazepines) for 1-week or less. Children may be on a stable dose of psychostimulants at the time of enrollment, but no change in medication, dose, or schedule in 3 months prior to study enrollment, with no anticipated dosing changes during the 6 months of the study. If participants are taking psychostimulants at the time of study entry, they should plan on continuing them for the 6 month duration of the study protocol including the 3-month and 6-month cognitive and behavioral testing time points. - Females of child bearing potential must agree to acceptable forms of birth control, which may include abstinence. - The child's parent/guardian must be able to keep an accurate seizure diary and be able and willing to comply with instructions and study procedures. - Informed consent from the child's legal guardian or legal representative. - Assent will be obtained from children according to each site's institutional guidelines. Exclusion Criteria: - Children with history of primary generalized seizures (absence, myoclonic, drop) - Children with mixed seizure disorder (e.g., Lennox-Gastaut Syndrome) - Children with sensory seizures only (i.e., auras) - Children with 6+ seizures in the previous week - Children with a history of status epilepticus - Children with a history of neonatal seizures - Children with diagnoses of pervasive developmental disorders (e.g., autism/autism spectrum disorders) - Children with progressive neurological disease (e.g., degenerative, progressive neoplasm) - Children with major medical disease (e.g., IDDM, cancer, renal failure) - Children with diseases with cognitive impact (e.g., inborn errors of metabolism, sickle cell disease with history of stroke) - Children with active cystercercosis documented on MRI - Children with cognitive impairment of sufficient severity that, in the opinion of the investigator, would diminish the likelihood of valid test performance (roughly corresponding to FSIQ less than 70) - Children with suicide attempt(s) at any point during their lifetime - Children with active suicide ideation - Children with chronic use of first generation antihistamines - Children using recreational drugs (including alcohol) - Children not fluent in either English or Spanish - Female children who are pregnant - Female children who are using oral contraceptives for birth control or for any other indication (e.g. acne treatment)

Additional Information

Official title Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)
Principal investigator David W. Loring, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Emory University.