Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy - Tabular View

Tracking Information

First Received Date ^ICMJE

December 9, 2005

Last Updated Date

September 12, 2007

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

1. Validity, feasibility and reliability of qolie-10 (test-retest, internal consistency) 2. Qolie-10 scores between groups 3. Body image scores between groups

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00264680 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse Events: nature and number between groups

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy

Official Title ^ICMJE

Validation Of Qolie-10 For Epilepsy, Comparison Of Quality Of Life In Patients Treated With Lamotrigine Or Valproic Acid

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: lamotrigine
Drug: valproic acid

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

333

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

Spain

Administrative Information

NCT ID ^ICMJE

NCT00264680

Responsible Party

Study ID Numbers ^ICMJE

LAM-2003-01

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trial, MD Phd

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP