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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: lamotrigine extended-release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00264615

LEP103944

Details and patient eligibility

About

Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.