Status:
COMPLETED
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
Lead Sponsor:
Yonsei University
Conditions:
Focal Epilepsy
Eligibility:
All Genders
4-16 years
Phase:
PHASE4
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 revi...
Eligibility Criteria
Inclusion
- Patients from age 4 to 16, who have been diagnosed with focal epilepsy
- Patients who have experienced minimal two unprovoked seizures, or patients who have had one unprovoked seizure and have shown focal abnormality in the EEG
- Patients who have not received any antiepileptic medications prior to the study (Those who have been treated with rescue medication are eligible)
- Patients with eligible consent or with legal guardians have given official consent
Exclusion
- Patients with progressive CNS disease, or systemic illness
- Patients with level of SGOT/SPGT above the doubled normal level or BUN/Creatinine above the 3 times of the normal range
- Patients who had used other anti-epileptic medication during any period of the trial, including baseline period. (Benzodiazepine used as rescue therapy is acceptable)
- Patients who show hypersensitive reaction to the study medication.
- Patients with any psychological problems.
- Patients deemed inappropriate for the study by the investigators
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02208492
Start Date
September 1 2011
End Date
February 1 2014
Last Update
December 9 2014
Active Locations (1)
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1
Severance hospital
Seoul, Seoul, South Korea, 120-752