Measurement Of Serum Levels Of Two Antiepileptic Drugs During Conversion In Patients With Epilepsy

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Epilepsy

Treatments

Drug: lamotrigine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00043914

LAM40013

Details and patient eligibility

About

This study includes patients 16 years of age or older with a confident diagnosis of epilepsy who are currently treated with an antiepileptic drug (AED) monotherapy but require a change in therapy due to inadequate seizure control and/or unacceptable side effects.

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

16 years old or older.
Have confident diagnosis of epilepsy.
Have been on the medication valproate for at least 3 months and is currently on a stable daily dose.
Male or female; females of child-bearing potential must have negative pregnancy test at screen and must agree to use an acceptable birth control method.

Exclusion criteria

A history of hypersensitivity to the drug being studied.
Currently being treated with or has been treated in the past with the drug being studied.
Undergoing polytherapy treatment with the medication valproate and one or more other antiepileptic drug(s).
If undergoing treatment with vagal nerve stimulation, has had device implanted more than 30 days prior to enrollment.
Has taken an investigational drug or the medication Felbatol within the previous 30 days.
Is abusing alcohol and/or other substances.