Last updated: 11/04/2018 08:41:43

Measurement Of Serum Levels Of Two Antiepileptic Drugs During Conversion In Patients With Epilepsy

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GSK study ID
LAM40013
See study documents
Clinicaltrials.gov ID
NCT00043914
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: A Multicenter, Open-Label Conversion of Valproate Monotherapy to Lamotrigine Monotherapy in Patients with Epilepsy
Trial description: This study includes patients 16 years of age or older with a confident diagnosis of epilepsy who are currently treated with an antiepileptic drug (AED) monotherapy but require a change in therapy due to inadequate seizure control and/or unacceptable side effects.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: lamotrigine
    • Enrollment:
    72
    Primary completion date:
    2003-29-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Sale M, Natarajan S, Biton V, Vuong A, Hammer A, Messenheimer J and Blum D. A dosing algorithm for converting from valproate monotherapy to lamotrigine monotherapy in patients with epilepsy. Epilepsy & Behavior, Volume 6, Issue 1, February 2005, Pages 63-70
    Sale M, Natarajan S, Biton V, Vuong A, Hammer A, Messenheimer J and Blum D. A dosing algorithm for converting from valproate monotherapy to lamotrigine monotherapy in patients with epilepsy. Epilepsy & Behavior, Volume 6, Issue 1, February 2005, Pages 63-70
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    January 2002 to January 2003
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    16+ years
    Accepts healthy volunteers
    No
    • INCLUSION CRITERIA:
    • 16 years old or older.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • INCLUSION CRITERIA:
    • 16 years old or older.
    • Have confident diagnosis of epilepsy.
    • Have been on the medication valproate for at least 3 months and is currently on a stable daily dose.
    • Male or female; females of child-bearing potential must have negative pregnancy test at screen and must agree to use an acceptable birth control method. EXCLUSION CRITERIA:
    • A history of hypersensitivity to the drug being studied.
    • Currently being treated with or has been treated in the past with the drug being studied.
    • Undergoing polytherapy treatment with the medication valproate and one or more other antiepileptic drug(s).
    • If undergoing treatment with vagal nerve stimulation, has had device implanted more than 30 days prior to enrollment.
    • Has taken an investigational drug or the medication Felbatol within the previous 30 days.
    • Is abusing alcohol and/or other substances.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2003-29-01
    Actual study completion date
    2003-30-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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