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Trial record 27 of 83 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00896987
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 12, 2009
Information provided by:
Korean Epilepsy Society

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: lamotrigine (Lamictal) Drug: Carbamazepine (Tegretol) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: 1
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
Drug: Carbamazepine (Tegretol)
Carbamazepine: titration for 8 weeks (100 mg~600 mg) and maintenance for 40 weeks (600 mg)
Other Name: Tegretol

Primary Outcome Measures :
  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 Outcome Measures :
  1. Seizure outcome and tolerability [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00896987

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

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Responsible Party: Korean Epilepsy Society Chairman, Korean Epilepsy Society Identifier: NCT00896987    
Other Study ID Numbers: 106172
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: May 12, 2009
Last Verified: May 2009
Keywords provided by Korean Epilepsy Society:
cognitive function
Additional relevant MeSH terms:
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Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers
Antimanic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents