Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

Overview

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.

Full Title of Study: “An Open, Randomized, Multicenter Comparative Clinical Trial of Lamotrigine or Carbamazepine for Cognitive Function as Initial Monotherapy in Adult Untreated Epilepsies”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2008

Interventions

  • Drug: lamotrigine (Lamictal)
    • lamotrigine: titration for 8 weeks (25 mg~200 mg per 2 weeks) and maintenance for 40 weeks (200 mg)
  • Drug: Carbamazepine (Tegretol)
    • Carbamazepine: titration for 8 weeks (100 mg~600 mg) and maintenance for 40 weeks (600 mg)

Arms, Groups and Cohorts

  • Experimental: 1
    • lamotrigine
  • Active Comparator: 2
    • carbamazepine

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Seizure outcome and tolerability
    • Time Frame: 48 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Korean Epilepsy Society
  • Collaborator
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Korean Epilepsy Society Chairman, Korean Epilepsy Society
  • Overall Official(s)
    • Sang-Ahm Lee, Professor, Principal Investigator, Asan Medical Center

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