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

GlaxoSmithKline72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy

Interventions

lamotrigineDRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Drug levels of lamotrigine.

Secondary Outcomes

This study has no secondary outcome measures.

Data from ClinicalTrials.gov

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