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Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

Information source: Korean Epilepsy Society
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: lamotrigine (Lamictal) (Drug); Carbamazepine (Tegretol) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Korean Epilepsy Society

Official(s) and/or principal investigator(s):
Sang-Ahm Lee, Professor, Principal Investigator, Affiliation: Asan Medical Center


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.

Clinical Details

Official title: An Open, Randomized, Multicenter Comparative Clinical Trial of Lamotrigine or Carbamazepine for Cognitive Function as Initial Monotherapy in Adult Untreated Epilepsies

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: Seizure outcome and tolerability


Minimum age: 16 Years. Maximum age: 60 Years. Gender(s): Both.


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


- 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 and Contacts

Asan Medical Center, Seoul, Korea, Republic of
Additional Information

Starting date: May 2006
Last updated: May 11, 2009

Page last updated: August 23, 2015

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