Official Title: “Validation Of Qolie-10 For Epilepsy, Comparison Of Quality Of Life In Patients Treated With Lamotrigine Or Valproic Acid”

Validation of qolie-10, an epilepsy specific quality of life questionnaire in patients treated with lamotrigine or valproic acid. Comparison of quality of life of epileptic patients treated with lamotrigine or valproic acid. Determination and assessment of the comparative safety of lamotrigine or valproic acid. Assessment and comparison of body image perception in women treated with lamotrigine or valproic acid.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: lamotrigine
• Drug: valproic acid

Primary Measures

• 1. Validity, feasibility and reliability of qolie-10 (test-retest, internal consistency) 2. Qolie-10 scores between groups 3. Body image scores between groups

Secondary Measures

• Adverse Events: nature and number between groups

Inclusion criteria:

• Diagnosis of epilepsy and normal neurological examination.
• Patients receiving lamotrigine or valproic acid at stable doses in monotherapy initiated 2 -4 months before.

Exclusion criteria:

• Pregnant or lactating women.
• Previous treatment with lamotrigine or valproic acid.
• Secondary epilepsy.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trial, MD Phd Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00264680

Study ID Number: LAM-2003-01

ClinicalTrials.gov Identifier: NCT00264680

Health Authority: Spain: Spanish Agency of Medicines