NCT00264680

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
333

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2003

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

2.4 years

First QC Date

December 9, 2005

Last Update Submit

October 26, 2017

Conditions

Epilepsy

Keywords

quality of lifeqolie-10epilepsylamotrigineValidation of questionnaire

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • Adverse Events: nature and number between groups

Interventions

lamotrigineDRUG
valproic acidDRUG
Also known as: lamotrigine

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of epilepsy and normal neurological examination.
  • Patients receiving lamotrigine or valproic acid at stable doses in monotherapy initiated 2 -4 months before.

You may not qualify if:

  • Pregnant or lactating women.
  • Previous treatment with lamotrigine or valproic acid.
  • Secondary epilepsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy

Interventions

LamotrigineValproic Acid

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TriazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 13, 2005

Study Start

October 1, 2003

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

October 30, 2017

Record last verified: 2017-10