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NCT00264680 Clinical Trial

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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00264680
Other study ID # LAM-2003-01
Secondary ID
Status Completed
Phase N/A
First received December 9, 2005
Last updated October 26, 2017
Start date October 1, 2003
Est. completion date March 1, 2006

Study information
Verified date October 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 333
Est. completion date March 1, 2006
Est. primary completion date March 1, 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• lamotrigine

• valproic acid

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Adverse Events: nature and number between groups
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