Status:
COMPLETED
The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy
Lead Sponsor:
Yonsei University
Conditions:
Epilepsy
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy of usual monotherapy and low dose combination of Lamotrigine and Valproate. Low dose combination may be more effective and tolerable because they are low dose and VPA reduce L...
Detailed Description
An Open label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies
Eligibility Criteria
Inclusion
- Age ≥16yr old
- 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
- Who has progressive CNS disease.
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00807989
Start Date
March 1 2008
End Date
May 1 2012
Last Update
July 27 2015
Active Locations (1)
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1
Yonsei Medical Center
Seoul, South Korea, 120-752