Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy
October 26, 2017 updated by: GlaxoSmithKline
Validation Of Qolie-10 For Epilepsy, Comparison Of Quality Of Life In Patients Treated With Lamotrigine Or Valproic Acid
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
333
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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1. Validity, feasibility and reliability of qolie-10 (test-retest, internal consistency) 2. Qolie-10 scores between groups 3. Body image scores between groups
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Secondary Outcome Measures
Outcome Measure |
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Adverse Events: nature and number between groups
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2003
Primary Completion (ACTUAL)
March 1, 2006
Study Completion (ACTUAL)
March 1, 2006
Study Registration Dates
First Submitted
December 9, 2005
First Submitted That Met QC Criteria
December 12, 2005
First Posted (ESTIMATE)
December 13, 2005
Study Record Updates
Last Update Posted (ACTUAL)
October 30, 2017
Last Update Submitted That Met QC Criteria
October 26, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Epilepsy
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- GABA Agents
- Sodium Channel Blockers
- Antimanic Agents
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Lamotrigine
- Valproic Acid
- Anticonvulsants
Other Study ID Numbers
- LAM-2003-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.