Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00264680
First received: December 9, 2005
Last updated: May 5, 2011
Last verified: May 2011
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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 4 |
| 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
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 May 19, 2013