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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
lamotrigine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring epilepsy, monotherapy conversion

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Drug levels of lamotrigine.

    Secondary Outcome Measures

    This study has no secondary outcome measures.

    Full Information

    First Posted
    August 14, 2002
    Last Updated
    October 6, 2017
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00043914
    Brief Title
    Measurement Of Serum Levels Of Two Antiepileptic Drugs During Conversion In Patients With Epilepsy
    Official Title
    A Multicenter, Open-Label Conversion of Valproate Monotherapy to Lamotrigine Monotherapy in Patients With Epilepsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 14, 2002 (Actual)
    Primary Completion Date
    January 29, 2003 (Actual)
    Study Completion Date
    January 29, 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy
    Keywords
    epilepsy, monotherapy conversion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    72 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    lamotrigine
    Primary Outcome Measure Information:
    Title
    Drug levels of lamotrigine.
    Secondary Outcome Measure Information:
    Title
    This study has no secondary outcome measures.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
    Citations:
    PubMed Identifier
    15652736
    Citation
    Sale ME, Natarajan S, Biton V, Vuong A, Hammer AE, Messenheimer JA, Blum D. A dosing algorithm for converting from valproate monotherapy to lamotrigine monotherapy in patients with epilepsy. Epilepsy Behav. 2005 Feb;6(1):63-70. doi: 10.1016/j.yebeh.2004.11.002.
    Results Reference
    result
    Links:
    URL
    https://www.clinicalstudydatarequest.com
    Description
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Informed Consent Form
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    LAM40013
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Individual Participant Data Set
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    LAM40013
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Dataset Specification
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    LAM40013
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Statistical Analysis Plan
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    LAM40013
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Annotated Case Report Form
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    LAM40013
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    LAM40013
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Clinical Study Report
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    LAM40013
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register

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

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