Status:
COMPLETED
Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies
Lead Sponsor:
Korean Epilepsy Society
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Epilepsy
Eligibility:
All Genders
16-60 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the effect of anti-epileptic drugs' (AEDs) long-term treatment on cognitive function. This study is an open-label, randomized, multicenter comparative trial of ...
Eligibility Criteria
Inclusion
- Age : 16\~60
- 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
- Follow-up loss
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00896987
Start Date
May 1 2006
End Date
December 1 2008
Last Update
May 12 2009
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea