Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korean Epilepsy Society
• Collaborator: GlaxoSmithKline
• Treatments: Anticonvulsants; Carbamazepine; Lamotrigine

Criteria

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