Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy

GlaxoSmithKline333 enrolled

Overview

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

OBSERVATIONAL

Enrollment

333

Conditions

Epilepsy

Interventions

lamotrigineDRUG

valproic acidDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

Adverse Events: nature and number between groups

Data from ClinicalTrials.gov

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