Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies
NCT ID: NCT00896987
Last Updated: 2009-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
121 participants
INTERVENTIONAL
2006-05-31
2008-12-31
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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1
lamotrigine
lamotrigine (Lamictal)
lamotrigine: titration for 8 weeks (25 mg\~200 mg per 2 weeks) and maintenance for 40 weeks (200 mg)
2
carbamazepine
Carbamazepine (Tegretol)
Carbamazepine: titration for 8 weeks (100 mg\~600 mg) and maintenance for 40 weeks (600 mg)
Interventions
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lamotrigine (Lamictal)
lamotrigine: titration for 8 weeks (25 mg\~200 mg per 2 weeks) and maintenance for 40 weeks (200 mg)
Carbamazepine (Tegretol)
Carbamazepine: titration for 8 weeks (100 mg\~600 mg) and maintenance for 40 weeks (600 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Seizure type was defined by MRI etc.
* Had more than 2 unprovoked seizures or 1 seizure with clear evidence for epilepsy (ex. positive in EEG or brain imaging)
* Need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2 weeks, baseline 4 weeks before)
* Is not pregnant by pregnancy test and is using contraceptive method
* Can report seizure diary by him/herself or his/her sick nurse
* Agreed to trial by written consent
Exclusion Criteria
* Canceled agreement
* Added other medication due to aggravated disease in 24 weeks
* Diagnosed as IGE
* Has progressive CNS disease by MRI or EEG
* Has serious systemic or psychological disease
* Under IQ 70
* Baseline lad data abnormality: Creatinine 2.0mg/dl or GOT/GPT 2 times higher than normal
* Abuse experience on alcohol or drugs
* Has experience on serious adverse event of any drug
* Previous experience on lamotrigine or carbamazepine
* Not suitable patients by investigator (uncooperative)
* Other reason which may interrupt the trial
16 Years
60 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Korean Epilepsy Society
OTHER
Responsible Party
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Korean Epilepsy Society
Principal Investigators
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Sang-Ahm Lee, Professor
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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106172
Identifier Type: -
Identifier Source: org_study_id
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