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Completed

NCT Number: NCT00896987

Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lamotrigine (Lamictal)

Drug

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

Other names: lamictal

carbamazepine (Tegretol)

Drug

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

Other names: Tegretol

Primary outcomes

  1. To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients

    Time frame: 48 weeks

Secondary outcomes

  1. Seizure outcome and tolerability

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Korean Epilepsy Society

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 12, 2009
Registry last updated
May 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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