Last updated: 11/04/2018 08:39:28

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

GSK study ID
LAM-2003-01
Clinicaltrials.gov ID
NCT00264680
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Validation Of Qolie-10 For Epilepsy, Comparison Of Quality Of Life In Patients Treated With Lamotrigine Or Valproic Acid
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: lamotrigine
  • Drug: valproic acid
    • Enrollment:
    333
    Primary completion date:
    2006-01-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    April 2004 to March 2006
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 50 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosis of epilepsy and normal neurological examination.
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    2006-01-03
    Actual study completion date
    2006-31-03

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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