Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

Korean Epilepsy Society

Status and phase

Completed

Phase 4

Conditions

Epilepsy

Treatments

Drug: Carbamazepine (Tegretol)

Drug: lamotrigine (Lamictal)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00896987

106172

Details and patient eligibility

About

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.

Enrollment

121 patients

Sex

All

Ages

16 to 60 years old

Volunteers

No Healthy Volunteers

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