Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa - Tabular View

Tracking Information

First Received Date ^ICMJE

December 9, 2005

Last Updated Date

May 15, 2009

Start Date ^ICMJE

October 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine

Original Primary Outcome Measures ^ICMJE

Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine

Change History

Complete list of historical versions of study NCT00264615 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Tmax and fluctuation index of lamotrigine
Adverse events, changes in blood pressure and heart rate
Change in seizure frequency during each of the study phases
Subject preference at End of Baseline and Extended-Release Treatment Phases

Original Secondary Outcome Measures ^ICMJE

1. Tmax and fluctuation index of lamotrigine
2. Adverse events, changes in blood pressure and heart rate
3. Change in seizure frequency during each of the study phases
4. Subject preference at End of Baseline and Extended-Release Treatment Phases

Descriptive Information

Brief Title ^ICMJE

Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa

Official Title ^ICMJE

An Open-Label, Double Conversion Study to Characterize the Pharmacokinetics of Lamotrigine When Switching Patients With Epilepsy on LAMICTAL Immediate-Release to Extended-Release Formulation and Vice Versa

Brief Summary

Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Single Group Assignment, Pharmacokinetics Study

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: lamotrigine extended-release

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

Confident diagnosis of epilepsy.
Currently on LAMICTAL and up to 2 concomitant AEDs (anti-epileptic drugs).

Exclusion Criteria:

Females of childbearing potential cannot be on hormonal contraceptives or hormone replacement therapy.

Gender

Both

Ages

13 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 ID ^ICMJE

NCT00264615

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

LEP103944

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

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