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

Yonsei University

Status and phase

Completed

Phase 4

Conditions

Epilepsy

Treatments

Drug: Lamotrigine/Valproate

Drug: Carbamazepine

Study type

Interventional

Funder types

Other

Identifiers

NCT00807989

109887

Details and patient eligibility

About

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.

Full 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

Enrollment

207 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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