Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

Korean Epilepsy Society121 enrolled

Overview

The purpose of this study is to compare the effect of anti-epileptic drugs' (AEDs) long-term treatment on cognitive function. This study is an open-label, randomized, multicenter comparative trial of lamotrigine versus carbamazepine. The planned enrollment is 100 patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

121

Conditions

Epilepsy

Interventions

lamotrigine (Lamictal)DRUG

lamotrigine: titration for 8 weeks (25 mg\~200 mg per 2 weeks) and maintenance for 40 weeks (200 mg)

Carbamazepine (Tegretol)DRUG

Carbamazepine: titration for 8 weeks (100 mg\~600 mg) and maintenance for 40 weeks (600 mg)

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age : 16\~60 * Seizure type was defined by MRI etc. * Had more than 2 unprovoked seizures or 1 seizure with clear evidence for epilepsy (ex. positive in EEG or brain imaging) * Need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2 weeks, baseline 4 weeks before) * Is not pregnant by pregnancy test and is using contraceptive method * Can report seizure diary by him/herself or his/her sick nurse * Agreed to trial by written consent Exclusion Criteria: * Follow-up loss * Canceled agreement * Added other medication due to aggravated disease in 24 weeks * Diagnosed as IGE * Has progressive CNS disease by MRI or EEG * Has serious systemic or psychological disease * Under IQ 70 * Baseline lad data abnormality: Creatinine 2.0mg/dl or GOT/GPT 2 times higher than normal * Abuse experience on alcohol or drugs * Has experience on serious adverse event of any drug * Previous experience on lamotrigine or carbamazepine * Not suitable patients by investigator (uncooperative) * Other reason which may interrupt the trial

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients

Time frame: 48 weeks

Secondary Outcomes

Seizure outcome and tolerability

Time frame: 48 weeks

Data from ClinicalTrials.gov

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