Measurement Of Serum Levels Of Two Antiepileptic Drugs During Conversion In Patients With Epilepsy

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00043914

First received: August 14, 2002

Last updated: February 11, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 14, 2002

Last Updated Date

February 11, 2013

Start Date ^ICMJE

January 2002

Primary Completion Date

January 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Drug levels of lamotrigine.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00043914 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

This study has no secondary outcome measures.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Measurement Of Serum Levels Of Two Antiepileptic Drugs During Conversion In Patients With Epilepsy

Official Title ^ICMJE

A Multicenter, Open-Label Conversion of Valproate Monotherapy to Lamotrigine Monotherapy in Patients With Epilepsy

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: lamotrigine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2003

Primary Completion Date

January 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00043914

Other Study ID Numbers ^ICMJE

LAM40013

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trial, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

February 2013

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

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