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Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy
This study is currently recruiting participants.
Verified by GlaxoSmithKline, September 2007
First Received: December 9, 2005   Last Updated: September 12, 2007   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00264680
  Purpose

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.


Condition Intervention Phase
Epilepsy
 Drug: lamotrigine
Drug: valproic acid
 Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Validation Of Qolie-10 For Epilepsy, Comparison Of Quality Of Life In Patients Treated With Lamotrigine Or Valproic Acid

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics: Epilepsy
Drug Information available for: Divalproex sodium Lamotrigine Valproic acid Valproate Sodium
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome 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 Outcome Measures:
  • Adverse Events: nature and number between groups

Estimated Enrollment: 333
Study Start Date: October 2003
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264680

Locations
Spain
GSK Clinical Trials Call Center Recruiting
Madrid, Spain, 28006
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Sevilla, Spain, 41071
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Puerto Real, Spain, 11510
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Puerto de Santa Maria, Spain, 11500
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Malaga, Spain, 29010
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Cordoba, Spain, 14004
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Murcia, Spain, 30120
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Salamanca, Spain, 37007
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Valencia, Spain, 46015
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Mieres, Spain, 33600
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Oviedo, Spain, 33006
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Lugo, Spain, 27004
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Orense, Spain, 32005
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Vigo, Spain, 36211
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Xativa, Spain, 46800
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Valencia, Spain, 46014
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Burgos, Spain, 09005
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Madrid, Spain, 28034
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Alcorcon, Spain, 28922
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Sevilla, Spain, 41014
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Baracaldo, Spain, 49803
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Pamplona, Spain, 31008
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Orihuela, Spain, 03314
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
La Coruna, Spain, 15006
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Valencia, Spain, 46017
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
El Ferrol, Spain, 15405
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Madrid, Spain, 28007
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Madrid, Spain, 28041
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Almeria, Spain, 04009
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Pontevedra, Spain, 36002
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Toledo, Spain, 45004
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Guadalajara, Spain, 19002
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
GSK Clinical Trials Call Center Recruiting
Alcazar de San Juan, Spain, 13600
Contact: GSK Clinical Trials Call Center     1 877 379 3718        
Spain, Madrid
GSK Clinical Trials Call Center Completed
Tres Cantos, Madrid, Spain, 28760
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trial, MD Phd GlaxoSmithKline
  More Information

No publications provided

Study ID Numbers: LAM-2003-01
Study First Received: December 9, 2005
Last Updated: September 12, 2007
ClinicalTrials.gov Identifier: NCT00264680     History of Changes
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by GlaxoSmithKline:
Validation of questionnaire
qolie-10
epilepsy
lamotrigine
quality of life

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Calcium Channel Blockers
Central Nervous System Diseases
Central Nervous System Depressants
Enzyme Inhibitors
Cardiovascular Agents
 Brain Diseases
Antimanic Agents
Valproic Acid
Pharmacologic Actions
Membrane Transport Modulators
Epilepsy
Therapeutic Uses
Lamotrigine
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010



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