The Effects on Cognitive Function of Levetiracetam (Keppra®) Compared to Carbamazepine (Tegretol®, Carmazepine®) as Monotherapy for Children With Partial Seizure; A Multicentric Randomized Controlled Study
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ClinicalTrials.gov Identifier: NCT02208492 |
Recruitment Status :
Completed
First Posted : August 5, 2014
Last Update Posted : December 9, 2014
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Tracking Information | |||
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First Submitted Date ICMJE | August 3, 2014 | ||
First Posted Date ICMJE | August 5, 2014 | ||
Last Update Posted Date | December 9, 2014 | ||
Study Start Date ICMJE | September 2011 | ||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine) [ Time Frame: 52 weeks ] changes in a series of follow-up neurocognitive, behavioral, and emotional function tests (Korean Wechsler Intelligence Scale for Children-Third edition (K-WISC-III, for subjects 6-16 years old)19, 20 or the Korean Weschler Preschool and Primary Scale of Intelligence-Third edition (K-WIPSSI-III, for ages 4-6), Korean-Child Behavior Checklist (K-CBCL), Children's Depression Inventory (CDI) 24 and Revised Children's Manifest Anxiety Scale (RCMAS))
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Original Primary Outcome Measures ICMJE |
Seizure Outcome [ Time Frame: 6 months ] The percentage of seizure free patients in the last six months period of the study
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Change History | |||
Current Secondary Outcome Measures ICMJE |
Seizure control efficacy [ Time Frame: 52 weeks ] Comparison of baseline frequency to final follow-up frequency during the last 24 weeks of the maintenance period(at last visit at 52 week time point)
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Original Secondary Outcome Measures ICMJE |
Behavior assessment [ Time Frame: 1 year ] Assessment of neuropsychological function of the patients on the study medication
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | The Effects on Cognitive Function of Levetiracetam (Keppra®) Compared to Carbamazepine (Tegretol®, Carmazepine®) as Monotherapy for Children With Partial Seizure; A Multicentric Randomized Controlled Study | ||
Official Title ICMJE | Not Provided | ||
Brief Summary | Unlike the first generation antiepileptic medications, newer drugs for epilepsy such as levetiracetam are reported to have less adverse effect in children but not many studies have systematically reviewed the subject. This study aims to prospectively evaluate the effect of levetiracetam on neurocognition, behavioral issues and quality of life, as well as its seizure control efficacy and other adverse events in pediatric epilepsy patients, in comparison to carbamazepine, one of the classic antiepileptic medication, widely prescribed for both partial and generalized seizures, despite its well known side effects. This multicenter, open-label, parallel-group trial is expected to enroll 130 patients from age 4 to 16 woh will be randomized into two groups, which will be prescribed with levetiracetam or carbamazepine. Series of neuropsychological assessment and behavioral and life evaluations of the patients will be performed at baseline period and after the 52 weeks of study period. |
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Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 4 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Focal Epilepsy | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Jung DE, Yu R, Yoon JR, Eun BL, Kwon SH, Lee YJ, Eun SH, Lee JS, Kim HD, Nam SO, Kim GH, Hwang SK, Eom S, Kang DR, Kang HC. Neuropsychological effects of levetiracetam and carbamazepine in children with focal epilepsy. Neurology. 2015 Jun 9;84(23):2312-9. doi: 10.1212/WNL.0000000000001661. Epub 2015 May 6. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
75 | ||
Original Actual Enrollment ICMJE | Same as current | ||
Actual Study Completion Date ICMJE | February 2014 | ||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 4 Years to 16 Years (Child) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Korea, Republic of | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02208492 | ||
Other Study ID Numbers ICMJE | 4-2011-0365 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Yonsei University | ||
Study Sponsor ICMJE | Yonsei University | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Yonsei University | ||
Verification Date | December 2014 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |