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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043914
• Other study ID #: LAM40013
• Status: Completed
• Phase: Phase 4
• First received: August 14, 2002
• Last updated: October 6, 2017
• Start date: January 14, 2002
• Est. completion date: January 29, 2003

Study information

• Verified date: October 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 29, 2003
• Est. primary completion date: January 29, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• lamotrigine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (1)

Sale ME, Natarajan S, Biton V, Vuong A, Hammer AE, Messenheimer JA, Blum D. A dosing algorithm for converting from valproate monotherapy to lamotrigine monotherapy in patients with epilepsy. Epilepsy Behav. 2005 Feb;6(1):63-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug levels of lamotrigine.
Secondary	This study has no secondary outcome measures.

External Links

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