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Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Korean Epilepsy Society
ClinicalTrials.gov Identifier:
NCT00896987
First received: May 11, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted

May 11, 2009
May 11, 2009
May 2006
December 2008   (final data collection date for primary outcome measure)
To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Seizure outcome and tolerability [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
  • Drug: lamotrigine (Lamictal)
    lamotrigine: titration for 8 weeks (25 mg~200 mg per 2 weeks) and maintenance for 40 weeks (200 mg)
    Other Name: lamictal
  • Drug: Carbamazepine (Tegretol)
    Carbamazepine: titration for 8 weeks (100 mg~600 mg) and maintenance for 40 weeks (600 mg)
    Other Name: Tegretol
  • Experimental: 1
    lamotrigine
    Intervention: Drug: lamotrigine (Lamictal)
  • Active Comparator: 2
    carbamazepine
    Intervention: Drug: Carbamazepine (Tegretol)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
16 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00896987
106172
No
Korean Epilepsy Society Chairman, Korean Epilepsy Society
Korean Epilepsy Society
GlaxoSmithKline
Principal Investigator: Sang-Ahm Lee, Professor Asan Medical Center
Korean Epilepsy Society
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP