Title
The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy
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)
Phase
Phase 4Lead Sponsor
Yonsei UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
EpilepsyIntervention/Treatment
lamotrigine valproic acid carbamazepine ...Study Participants
207To 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.
An Open label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies
Lamotrigine and Valproate combination therapy
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
| Event Type | Organ System | Event Term | Carbamazepine | Lamotrigine/Valproate |
|---|
* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.
