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

GlaxoSmithKline45 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Epilepsy

Interventions

lamotrigine extended-releaseDRUG

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

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 (12)

GSK Investigational Site

Anniston, Alabama, United States

GSK Investigational Site

Sun City, Arizona, United States

GSK Investigational Site

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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