Overview

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

Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Lamotrigine
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.