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 lamotrigineAdverse 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
|
