Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.
Full Title of Study: “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 Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Study Primary Completion Date: June 2006
- Drug: lamotrigine extended-release
Clinical Trial Outcome Measures
- Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine
- 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
Participating in This Clinical Trial
- 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 Eligibility: All
Minimum Age: 13 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Provider of Information About this Clinical Study
- Overall Official(s)
- GSK Clinical Trials, Study Director, GlaxoSmithKline
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.
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