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

Validation Of Qolie-10 For Epilepsy, Comparison Of Quality Of Life In Patients Treated With Lamotrigine Or Valproic Acid

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00264680

Enrollment

333

Registered

2005-12-13

Start date

2003-10-01

Completion date

2006-03-01

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

quality of life, qolie-10, epilepsy, lamotrigine, Validation of questionnaire

Brief summary

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.

Interventions

DRUGlamotrigine

DRUGvalproic acid

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Adverse Events: nature and number between groups	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026