The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy

Study Overview
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Brief Summary
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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 Lamotrigine metabolism.

Detailed Description
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An Open label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies

Official Title
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An Open Label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies (Phase Ⅳ)

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Carbamazepine
* Drug: Lamotrigine/Valproate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carbamazepine<br>Carbamazepine | Drug: Carbamazepine<br> <br> |
| Experimental: Lamotrigine/Valproate<br>Lamotrigine and Valproate combination therapy | Drug: Lamotrigine/Valproate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention Rate After 52 Weeks Maintenance Period | * Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure Free Rate for 24 Weeks at Initial Target Dose |  | 24 weeks | 
| Seizure Free Rate for 52 Weeks at Initial Target Dose |  | 52 weeks |