Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

Phase 4

Completed

• Conditions: Epilepsy
• Interventions: Drug: lamotrigine (Lamictal); Drug: Carbamazepine (Tegretol)

• Registration Number: NCT00896987
• Lead Sponsor: Korean Epilepsy Society

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-05
• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-05-11
• Last Update Submitted: 2009-05-11
• Study First Posted: 2009-05-12
• Last Update Posted: 2009-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	lamotrigine (Lamictal)	lamotrigine
2	Carbamazepine (Tegretol)	carbamazepine

Primary Outcome Measures

Name	Time	Method
To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients	48 weeks

Secondary Outcome Measures

Name	Time	Method
Seizure outcome and tolerability	48 weeks

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of