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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00264680
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Epilepsy Drug: lamotrigine Drug: valproic acid

Study Design

Study Type : Observational
Actual Enrollment : 333 participants
Official Title: Validation Of Qolie-10 For Epilepsy, Comparison Of Quality Of Life In Patients Treated With Lamotrigine Or Valproic Acid
Actual Study Start Date : October 1, 2003
Primary Completion Date : March 1, 2006
Study Completion Date : March 1, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Drug: lamotrigine Drug: valproic acid
    Other Name: lamotrigine

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Adverse Events: nature and number between groups

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264680


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00264680     History of Changes
Other Study ID Numbers: LAM-2003-01
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Keywords provided by GlaxoSmithKline:
quality of life
qolie-10
epilepsy
lamotrigine
Validation of questionnaire

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lamotrigine
Anticonvulsants
Valproic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Enzyme Inhibitors
GABA Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs