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Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy
This study has been completed.

First Received on December 9, 2005.   Last Updated on May 5, 2011   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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events: nature and number between groups [ Designated as safety issue: No ]

Enrollment: 155
Study Start Date: October 2003
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  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
Tres Cantos, Madrid, Spain, 28760
GSK Clinical Trials Call Center
Alcazar de San Juan, Spain, 13600
GSK Clinical Trials Call Center
Alcorcon, Spain, 28922
GSK Clinical Trials Call Center
Almeria, Spain, 04009
GSK Clinical Trials Call Center
Baracaldo, Spain, 49803
GSK Clinical Trials Call Center
Burgos, Spain, 09005
GSK Clinical Trials Call Center
Cordoba, Spain, 14004
GSK Clinical Trials Call Center
El Ferrol, Spain, 15405
GSK Clinical Trials Call Center
Guadalajara, Spain, 19002
GSK Clinical Trials Call Center
La Coruna, Spain, 15006
GSK Clinical Trials Call Center
Lugo, Spain, 27004
GSK Clinical Trials Call Center
Madrid, Spain, 28034
GSK Clinical Trials Call Center
Madrid, Spain, 28007
GSK Clinical Trials Call Center
Madrid, Spain, 28006
GSK Clinical Trials Call Center
Madrid, Spain, 28041
GSK Clinical Trials Call Center
Malaga, Spain, 29010
GSK Clinical Trials Call Center
Mieres, Spain, 33600
GSK Clinical Trials Call Center
Murcia, Spain, 30120
GSK Clinical Trials Call Center
Orense, Spain, 32005
GSK Clinical Trials Call Center
Orihuela, Spain, 03314
GSK Clinical Trials Call Center
Oviedo, Spain, 33006
GSK Clinical Trials Call Center
Pamplona, Spain, 31008
GSK Clinical Trials Call Center
Pontevedra, Spain, 36002
GSK Clinical Trials Call Center
Puerto de Santa Maria, Spain, 11500
GSK Clinical Trials Call Center
Puerto Real, Spain, 11510
GSK Clinical Trials Call Center
Salamanca, Spain, 37007
GSK Clinical Trials Call Center
Sevilla, Spain, 41071
GSK Clinical Trials Call Center
Sevilla, Spain, 41014
GSK Clinical Trials Call Center
Toledo, Spain, 45004
GSK Clinical Trials Call Center
Valencia, Spain, 46014
GSK Clinical Trials Call Center
Valencia, Spain, 46017
GSK Clinical Trials Call Center
Valencia, Spain, 46015
GSK Clinical Trials Call Center
Vigo, Spain, 36211
GSK Clinical Trials Call Center
Xativa, Spain, 46800
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri A. Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00264680     History of Changes
Other Study ID Numbers: LAM-2003-01
Study First Received: December 9, 2005
Last Updated: May 5, 2011
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:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lamotrigine
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012



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