Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Emory University
Sponsor:
Collaborator:
Patient Centered Outcome Research Institute
Information provided by (Responsible Party):
David Loring, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT01891890
First received: June 28, 2013
Last updated: May 13, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Epilepsy, Partial
Epilepsy, Localization Related
Adverse Effects
Drug: Oxcarbazepine
Drug: levetiracetam
Drug: lamotrigine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Conners' Continuous Performance Test (CPT) Confidence Interval [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Conners' CPT is a measure of sustained attention.


Secondary Outcome Measures:
  • Child Behavior Checklist [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Child Behavior Checklist is a measure pf specific behavioral and emotional problems are rated by the child's parent/guardian


Other Outcome Measures:
  • Weschler Intelligence Scale for Children-IV Processing Speed [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Story Memory [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Symbol Digit Modalities Test [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Grooved Pegboard [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Columbia Suicidality Severity Rating Scale [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]
  • Youth Self Report [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Affective Reactivity Scale [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Pediatric Neuro-QOL [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Parenting Stress Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Pediatric Inventory for Parents [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: August 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lamotrigine
lamotrigine 7.0 mg/kg tablets or chewable tablets administered daily in 2 equally divided doses
Drug: lamotrigine
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.
Other Name: Lamictal
Active Comparator: oxcarbazepine
oxcarbazepine 25 mg/kg tablets or liquid administered daily in 2 equally divided doses
Drug: Oxcarbazepine
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.
Other Name: Trileptal
Active Comparator: levetiracetam
levetiracetam 30 mg/kg tablet or liquid administered daily in 2 equally divided doses
Drug: levetiracetam
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.
Other Name: Keppra

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891890

Contacts
Contact: Becky Kinkead, Ph.D 404-727-3710 bkinkea@emory.edu

Locations
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Kara Christensen    501-346-1850    kchristensen@uams.org   
Contact: James Outlaw    501-346-1850    outlawjt@archildrens.org   
Principal Investigator: Gregory B. Sharp, MD         
United States, California
University of California at San Diego Recruiting
San Diego, California, United States, 92092
Contact: Angela Ballantyne    858-822-6704    aballantyne@ucsd.edu   
Principal Investigator: Doris A. Trauner, MD         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Janine Schenborn    720-777-6895    janine.schenborn@childrenscolorado.org   
Contact: Megan Brocato    720-777-6895    megan.brocato@childrenscolorado.org   
Principal Investigator: Kevin Chapman, MD         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Tekolla Belaineh    202-476-2120    tbelaine@cnmc.org   
Principal Investigator: Joan A. Conry, MD         
United States, Georgia
Children's Healtcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30342
Contact: Novell McGloster       Novell.McGloster@choa.org   
Contact: Thomas Burns       thomas.burns@choa.org   
Principal Investigator: Thomas Burns, PsyD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Eric Kossoff, MD       ekossoff@jhmi.edu   
Contact: Tony Stanfield    410-502-0965    astanfi1@jhmi.edu   
Principal Investigator: Eric Kossoff, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Michele Jackson    857-218-5337    michele.jackson@childrens.harvard.edu   
Contact: Jacqueline Klelm    857-218-5337    jacqueline.klelm@childrens.harvard.edu   
Principal Investigator: Tobias Loddenkemper, MD         
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: La June Grayson    314-454-6120    pnrc@neuro.wustl.edu   
Principal Investigator: Liu-Lin Thio, MD/PHD         
United States, New York
University of Rochester Recruiting
Monroe, New York, United States, 14642
Contact: Amy Vierhile    585-275-4762    amy_vierhile@urmc.rochester.edu   
Principal Investigator: David D. Wang, MD         
United States, Ohio
Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Jody Hessling    513-636-7314    jody.hessling@cchmc.org   
Principal Investigator: Diego Morita, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sudha Kessler       KESSLERS@email.chop.edu   
Contact: Casey Gorman    215-590-1719    gormanC@email.chop.edu   
Principal Investigator: Sudha A. Kessler, MD         
United States, Tennessee
Le Bonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Tracee Ridley-Pryor    901-287-5207    Tracee.Ridley@lebonheur.org   
Contact: Catherine Horobetz    901-287-5338    Catherine.Horobetz@lebonheur.org   
Principal Investigator: James W. Wheless, MD         
United States, Virginia
Eastern Virginia Medical School Recruiting
Norfolk, Virginia, United States, 23510
Contact: Matt Frank, MD       Matthew.Frank@chkd.org   
Contact: Terrie Conklin    757-668-9256    terrie.conklin@chkd.org   
Principal Investigator: Matt Frank, MD         
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23284
Principal Investigator: Syndi Seinfeld         
Sponsors and Collaborators
Emory University
Patient Centered Outcome Research Institute
Investigators
Principal Investigator: David W. Loring, PhD Emory University
  More Information

Additional Information:
No publications provided

Responsible Party: David Loring, PhD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01891890     History of Changes
Other Study ID Numbers: IRB00066541, PCORI 527
Study First Received: June 28, 2013
Last Updated: May 13, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Epilepsies, Partial
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Lamotrigine
Oxcarbazepine
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on May 21, 2015