Back to resultsSpanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
lamotrigine
valproic acid
Sponsored by
About this trial
This is an observational trial for Epilepsy focused on measuring quality of life, qolie-10, epilepsy, lamotrigine, Validation of questionnaire
Eligibility 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.
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00264680
Brief Title
Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy
Official Title
Validation Of Qolie-10 For Epilepsy, Comparison Of Quality Of Life In Patients Treated With Lamotrigine Or Valproic Acid
Study Type
Observational
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2003 (Actual)
Primary Completion Date
March 1, 2006 (Actual)
Study Completion Date
March 1, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
quality of life, qolie-10, epilepsy, lamotrigine, Validation of questionnaire
7. Study Design
Enrollment
333 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
lamotrigine
Intervention Type
Drug
Intervention Name(s)
valproic acid
Other Intervention Name(s)
lamotrigine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Adverse Events: nature and number between groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy
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