Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa

September 22, 2016 updated by: GlaxoSmithKline

An Open-label, Double Conversion Study to Characterize the Pharmacokinetics of Lamotrigine When Switching Patients With Epilepsy on LAMICTAL Immediate-release to Extended-release Formulation and Vice Versa

Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

45

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • GSK Investigational Site
    • Arizona
      • Sun City, Arizona, United States, 85351
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • GSK Investigational Site
      • Lexington, Kentucky, United States, 40536-0284
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • GSK Investigational Site
    • Nevada
      • Reno, Nevada, United States, 89521
        • GSK Investigational Site
    • New York
      • New York, New York, United States, 10016
        • GSK Investigational Site
    • Ohio
      • Toledo, Ohio, United States, 43614-5809
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23219
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Confident diagnosis of epilepsy.
  • Currently on LAMICTAL and up to 2 concomitant AEDs (anti-epileptic drugs).

Exclusion Criteria:

  • Females of childbearing potential cannot be on hormonal contraceptives or hormone replacement therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine

Secondary Outcome Measures

Outcome Measure
Tmax and fluctuation index of lamotrigine
Adverse events, changes in blood pressure and heart rate
Change in seizure frequency during each of the study phases
Subject preference at End of Baseline and Extended-Release Treatment Phases

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

December 9, 2005

First Submitted That Met QC Criteria

December 12, 2005

First Posted (Estimate)

December 13, 2005

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEP103944

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Annotated Case Report Form
    Information identifier: LEP103944
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: LEP103944
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistical Analysis Plan
    Information identifier: LEP103944
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: LEP103944
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: LEP103944
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: LEP103944
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Study Protocol
    Information identifier: LEP103944
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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