The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy
- Registration Number
- NCT00807989
- Lead Sponsor
- Yonsei University
- 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 Lamotrigine metabolism.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lamotrigine/Valproate Lamotrigine/Valproate Lamotrigine and Valproate combination therapy Carbamazepine Carbamazepine Carbamazepine
- Primary Outcome Measures
Name Time Method Retention Rate After 52 Weeks Maintenance Period 52 weeks \* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.
- Secondary Outcome Measures
Name Time Method Seizure Free Rate for 24 Weeks at Initial Target Dose 24 weeks Seizure Free Rate for 52 Weeks at Initial Target Dose 52 weeks
Trial Locations
- Locations (1)
Yonsei Medical Center
🇰🇷Seoul, Korea, Republic of