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Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00896987
First Posted: May 12, 2009
Last Update Posted: May 12, 2009
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.
Collaborator:
GlaxoSmithKline
Information provided by:
Korean Epilepsy Society
  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
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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Seizure outcome and tolerability [ Time Frame: 48 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Korean Epilepsy Society Chairman, Korean Epilepsy Society
ClinicalTrials.gov Identifier: NCT00896987     History of Changes
Other Study ID Numbers: 106172
First Submitted: May 11, 2009
First Posted: May 12, 2009
Last Update Posted: May 12, 2009
Last Verified: May 2009

Keywords provided by Korean Epilepsy Society:
Epilepsy
lamotrigine
cognitive function

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lamotrigine
Anticonvulsants
Carbamazepine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers