Measurement Of Serum Levels Of Two Antiepileptic Drugs During Conversion In Patients With Epilepsy - Full Text View

Purpose

This study includes patients 16 years of age or older with a confident diagnosis of epilepsy who are currently treated with an antiepileptic drug (AED) monotherapy but require a change in therapy due to inadequate seizure control and/or unacceptable side effects.

Condition	Intervention	Phase
Epilepsy	Drug: lamotrigine	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter, Open-Label Conversion of Valproate Monotherapy to Lamotrigine Monotherapy in Patients With Epilepsy

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Drug levels of lamotrigine.

Secondary Outcome Measures:

This study has no secondary outcome measures.

Estimated Enrollment:	72
Study Start Date:	January 2002
Study Completion Date:	January 2003
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

16 years old or older.
Have confident diagnosis of epilepsy.
Have been on the medication valproate for at least 3 months and is currently on a stable daily dose.
Male or female; females of child-bearing potential must have negative pregnancy test at screen and must agree to use an acceptable birth control method.

EXCLUSION CRITERIA:

A history of hypersensitivity to the drug being studied.
Currently being treated with or has been treated in the past with the drug being studied.
Undergoing polytherapy treatment with the medication valproate and one or more other antiepileptic drug(s).
If undergoing treatment with vagal nerve stimulation, has had device implanted more than 30 days prior to enrollment.
Has taken an investigational drug or the medication Felbatol within the previous 30 days.
Is abusing alcohol and/or other substances.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043914

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Locations

United States, Alabama
GSK Clinical Trials Call Center
Huntsville, Alabama, United States, 35801
United States, Arkansas
GSK Clinical Trials Call Center
Little Rock, Arkansas, United States, 72205
United States, Colorado
GSK Clinical Trials Call Center
Denver, Colorado, United States, 80218
United States, Florida
GSK Clinical Trials Call Center
Gainesville, Florida, United States, 32608
GSK Clinical Trials Call Center
Jacksonville, Florida, United States, 32209
GSK Clinical Trials Call Center
Miami, Florida, United States, 33136
GSK Clinical Trials Call Center
Panama City, Florida, United States, 32405
GSK Clinical Trials Call Center
W. Palm Beach, Florida, United States, 33407
United States, Georgia
GSK Clinical Trials Call Center
Atlanta, Georgia, United States, 30338
GSK Clinical Trials Call Center
Augusta, Georgia, United States, 30912
GSK Clinical Trials Call Center
Decatur, Georgia, United States, 30033
United States, Kentucky
GSK Clinical Trials Call Center
Lexington, Kentucky, United States, 40536
United States, Louisiana
GSK Clinical Trials Call Center
Marrero, Louisiana, United States, 70072
United States, Massachusetts
GSK Clinical Trials Call Center
Newton Center, Massachusetts, United States, 02459
United States, Michigan
GSK Clinical Trials Call Center
Detroit, Michigan, United States, 48202
GSK Clinical Trials Call Center
Traverse City, Michigan, United States, 49684
United States, Minnesota
GSK Clinical Trials Call Center
Golden Valley, Minnesota, United States, 55422
United States, Tennessee
GSK Clinical Trials Call Center
Memphis, Tennessee, United States, 38105
United States, Texas
GSK Clinical Trials Call Center
Austin, Texas, United States, 78756
GSK Clinical Trials Call Center
Ft. Worth, Texas, United States, 76107
GSK Clinical Trials Call Center
San Antonio, Texas, United States, 78229
United States, Washington
GSK Clinical Trials Call Center
Seattle, Washington, United States, 98122
GSK Clinical Trials Call Center
Tacoma, Washington, United States, 98305
United States, Wisconsin
GSK Clinical Trials Call Center
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trial, MD

GlaxoSmithKline

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00043914 History of Changes
Other Study ID Numbers:	LAM40013
Study First Received:	August 14, 2002
Last Updated:	February 11, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

epilepsy
monotherapy conversion

Additional relevant MeSH terms:

Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lamotrigine
Anticonvulsants
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013