Status:
TERMINATED
Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)
Lead Sponsor:
Emory University
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Epilepsy, Partial
Epilepsy, Localization Related
Eligibility:
All Genders
5-16 years
Phase:
PHASE3
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 di...
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 Epi...
Eligibility Criteria
Inclusion
- 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 diagnosed epilepsy as defined by one of the following definitions :
- At least two unprovoked seizures occurring more than 24-hours apart, or
- One unprovoked seizure and a probability of further seizures similar to the general recurrence risk after two unprovoked seizures (approximately 75% or more), or
- At least two seizures in a setting of reflex epilepsy
- 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 antiepileptic drug (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
- 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., Insulin-Dependent Diabetes Mellitus (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 cysticercosis 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 Full Scale Intelligence Quotient (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)
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2015
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01891890
Start Date
August 1 2013
End Date
October 23 2015
Last Update
September 19 2017
Active Locations (14)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72205
2
University of California at San Diego
San Diego, California, United States, 92092
3
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010