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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
  Purpose

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.


Condition Intervention Phase
Epilepsy
 Drug: lamotrigine (Lamictal)
Drug: Carbamazepine (Tegretol)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Randomized, Multicenter Comparative Clinical Trial of Lamotrigine or Carbamazepine for Cognitive Function as Initial Monotherapy in Adult Untreated Epilepsies

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by Korean Epilepsy Society:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Seizure outcome and tolerability [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 121
Study Start Date: May 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
lamotrigine
 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
Active Comparator: 2
carbamazepine
 Drug: Carbamazepine (Tegretol)
Carbamazepine: titration for 8 weeks (100 mg~600 mg) and maintenance for 40 weeks (600 mg)
Other Name: Tegretol

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896987

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Korean Epilepsy Society
GlaxoSmithKline
Investigators
Principal Investigator: Sang-Ahm Lee, Professor Asan Medical Center
  More Information

No publications provided

Responsible Party: Korean Epilepsy Society Chairman, Korean Epilepsy Society
ClinicalTrials.gov Identifier: NCT00896987     History of Changes
Other Study ID Numbers: 106172
Study First Received: May 11, 2009
Last Updated: May 11, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean Epilepsy Society:
Epilepsy
lamotrigine
cognitive function

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Carbamazepine
Lamotrigine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013