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

Condition(s) targeted: Epilepsy

Intervention: lamotrigine (Drug); valproic acid (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD Phd, Study Director, Affiliation: GlaxoSmithKline

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.

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

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

Primary outcome: 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 outcome: Adverse Events: nature and number between groups

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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.

GSK Clinical Trials Call Center, Madrid 28006, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Sevilla 41071, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Puerto Real 11510, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Puerto de Santa Maria 11500, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Malaga 29010, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Cordoba 14004, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Murcia 30120, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Salamanca 37007, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Burgos 09005, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Mieres 33600, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Oviedo 33006, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Lugo 27004, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Orense 32005, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Vigo 36211, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Xativa 46800, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Valencia 46014, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Valencia 46015, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Madrid 28034, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Alcorcon 28922, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Sevilla 41014, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Baracaldo 49803, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Pamplona 31008, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, El Ferrol 15405, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, La Coruna 15006, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Valencia 46017, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Orihuela 03314, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Madrid 28007, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Madrid 28041, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Almeria 04009, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Pontevedra 36002, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Toledo 45004, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Guadalajara 19002, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Alcazar de San Juan 13600, Spain; Recruiting
GSK Clinical Trials Call Center, Phone: 1 877 379 3718

GSK Clinical Trials Call Center, Tres Cantos, Madrid 28760, Spain; Completed

Starting date: October 2003
Last updated: September 12, 2007