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

Condition(s) targeted: Epilepsy

Intervention: lamotrigine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: A Multicenter, Open-Label Conversion of Valproate Monotherapy to Lamotrigine Monotherapy in Patients With Epilepsy

Study design: Interventional, Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Primary outcome: Drug levels of lamotrigine.

Secondary outcome: This study has no secondary outcome measures.

Minimum age: 16 Years. Gender(s): Both.

Criteria:

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.

GSK Clinical Trials Call Center, Huntsville, Alabama 35801, United States

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Starting date: January 2002
Last updated: March 7, 2006