Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00896987

Enrollment

121

Registered

2009-05-12

Start date

2006-05-31

Completion date

2008-12-31

Last updated

2009-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Epilepsy, lamotrigine, cognitive function

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.

Interventions

DRUGlamotrigine (Lamictal)

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

DRUGCarbamazepine (Tegretol)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 60 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Seizure outcome and tolerability	48 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026