Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: lamotrigine extended-release (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, 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: Treatment, Non-Randomized, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
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 Clinical Trials Call Center, Anniston, Alabama 36207, United States
GSK Clinical Trials Call Center, Phoenix, Arizona 85013, United States
GSK Clinical Trials Call Center, Sun City, Arizona 85351, United States
GSK Clinical Trials Call Center, Melbourne, Florida 32901, United States
GSK Clinical Trials Call Center, Lexington, Kentucky 40536, United States
GSK Clinical Trials Call Center, Lexington, Kentucky 23712, United States
GSK Clinical Trials Call Center, Boston, Massachusetts 02118, United States
GSK Clinical Trials Call Center, Ann Arbor, Michigan 48109, United States
GSK Clinical Trials Call Center, Reno, Nevada 89521, United States
GSK Clinical Trials Call Center, New York, New York 10016, United States
GSK Clinical Trials Call Center, Toledo, Ohio 43614, United States
GSK Clinical Trials Call Center, Philadelphia, Pennsylvania 19140, United States
GSK Clinical Trials Call Center, Nashville, Tennessee 37212, United States
GSK Clinical Trials Call Center, Dallas, Texas 75230, United States
GSK Clinical Trials Call Center, Richmond, Virginia 23219, United States
Additional Information
Starting date: August 2005
Last updated: October 5, 2006
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