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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: lamotrigine extended-release (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

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

Secondary outcome:

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

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Anniston, Alabama 36207, United States

GSK Investigational Site, Sun City, Arizona 85351, United States

GSK Investigational Site, Lexington, Kentucky 40503, United States

GSK Investigational Site, Lexington, Kentucky 40536-0284, United States

GSK Investigational Site, Boston, Massachusetts 02215, United States

GSK Investigational Site, Toledo, Ohio 43614-5809, United States

GSK Investigational Site, Dallas, Texas 75230, United States

GSK Investigational Site, Richmond, Virginia 23219, United States

Additional Information

Related 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.

Starting date: October 2005
Last updated: April 14, 2015

Page last updated: August 23, 2015

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