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

This study has been completed.

First Received on December 9, 2005. Last Updated on March 17, 2011 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00264615

Purpose

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

Condition	Intervention	Phase
Epilepsy	Drug: lamotrigine extended-release	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

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

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	45
Study Start Date:	October 2005

Intervention Details:

Other Name: lamotrigine extended-release

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264615

Locations

United States, Alabama
GSK Investigational Site
Anniston, Alabama, United States, 36207
United States, Arizona
GSK Investigational Site
Sun City, Arizona, United States, 85351
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0284
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02215
United States, Ohio
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75230
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23219

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Publications:

Tompson DJ, Ali I, Oliver-Willwong R, Job S, Zhu L, Lemme F, Hammer AE, Vuong A, Messenheimer JA. Steady-state pharmacokinetics of lamotrigine when converting from a twice-daily immediate-release to a once-daily extended-release formulation in subjects with epilepsy (The COMPASS Study). Epilepsia. 2008 Mar;49(3):410-7. Epub 2007 Sep 6.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00264615 History of Changes
Other Study ID Numbers:	LEP103944
Study First Received:	December 9, 2005
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

epilepsy
once daily dosing
seizure
pharmacokinetics

Additional relevant MeSH terms:

Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lamotrigine
Calcium Channel Blockers
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012