The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy
NCT ID: NCT00807989
Last Updated: 2015-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
207 participants
INTERVENTIONAL
2008-03-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Carbamazepine
Carbamazepine
Carbamazepine
Lamotrigine/Valproate
Lamotrigine and Valproate combination therapy
Lamotrigine/Valproate
Interventions
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Carbamazepine
Lamotrigine/Valproate
Eligibility Criteria
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Inclusion Criteria
* Who are diagnosed as epilepsy definitely
* Who have minimum 2 unprovoked seizures and minimum 1 seizure in previous 3 months
* Who need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2weeks)
* Who is not pregnant
* Who can report seizure diary by him/herself or caregiver
* Who agree to this trial and provide informed consent.
* Type of seizures : of generalized tonic-clonic, complex partial, and/or simple partial motor seizures;
Exclusion Criteria
* Has serious systemic or psychiatric disease
* Who is not suitable by investigator(uncooperative)
* Who can not fill up diary check card
* Is pregnant, breastfeeding, or planning to become pregnant
* Exclusion - absence s. juvenile myoclonic epilepsy, atonic seizure, alcohol or other substance abusers, mental retardation etc.
* Who cancels to agree to this trial and provide informed consent.
* ALT, AST, bilirubin and BUN/Cr levels are more than twice normal range of them
* WBC value is 2000 and less, Hb value is 9.0 and less, platelet count is 100,000 and less in CBC
* Who took investigation products before participating this study
16 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Byung-In Lee
Role: PRINCIPAL_INVESTIGATOR
Yonsei Univ.
Kyoung Heo
Role: PRINCIPAL_INVESTIGATOR
Yonsei Univ.
Sang-Kun Lee
Role: PRINCIPAL_INVESTIGATOR
Seoul National Univ.
Sang-Ahm Lee
Role: PRINCIPAL_INVESTIGATOR
Ulsan Univ.
Dong-Jin Shin
Role: PRINCIPAL_INVESTIGATOR
Gacheon Univ.
Hong-Ki Song
Role: PRINCIPAL_INVESTIGATOR
Hallym Univ.
Young-In Kim
Role: PRINCIPAL_INVESTIGATOR
Catholic Univ.
Se-Jin Lee
Role: PRINCIPAL_INVESTIGATOR
Youngnam Univ.
Sang-Ho Kim
Role: PRINCIPAL_INVESTIGATOR
Donga Univ.
Myung-Gyu Kim
Role: PRINCIPAL_INVESTIGATOR
Cheonnam Univ.
Yo-Sik Kim
Role: PRINCIPAL_INVESTIGATOR
Wonkwang Univ.
Sang-Do Lee
Role: PRINCIPAL_INVESTIGATOR
Dongsan Hosp.
Sung-Eun Kim
Role: PRINCIPAL_INVESTIGATOR
Pusan-Bak Hosp.
Sung-Pa Park
Role: PRINCIPAL_INVESTIGATOR
Kyungbuk Univ.
Joo-Yong Kim
Role: PRINCIPAL_INVESTIGATOR
Hanrim Univ.
Ok-Jun Kim
Role: PRINCIPAL_INVESTIGATOR
Bundang Cha
Soon-Ki Noh
Role: PRINCIPAL_INVESTIGATOR
Bong-Sang Hosp.
Hyang-Woon Lee
Role: PRINCIPAL_INVESTIGATOR
I-wha Univ.
Jae-Moon Kim
Role: PRINCIPAL_INVESTIGATOR
Chungnam Univ.
Locations
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Yonsei Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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109887
Identifier Type: -
Identifier Source: org_study_id
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