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

• Status: Completed
• Trial end date: 2003-01-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Lamotrigine

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.