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

Overview

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

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
• Study Primary Completion Date: June 2006

Interventions

• Drug: lamotrigine extended-release

Clinical Trial Outcome Measures

Primary Measures

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

Secondary 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 13 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • GlaxoSmithKline
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • GSK Clinical Trials, Study Director, GlaxoSmithKline

References

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.