Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy
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...
Brief Summary
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: March 2006
Intervention(s) in this Clinical Trial
- Drug: lamotrigine
- Drug: valproic acid
Outcome Measures for this Clinical Trial
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
- Safety Issue?: No
Secondary Measures
- Adverse Events: nature and number between groups
- Safety Issue?: No
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: GlaxoSmithKline Industry
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00264680
