Last updated: 11/04/2018 08:50:53

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

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GSK study ID
LEP103944
See study documents
Clinicaltrials.gov ID
NCT00264615
See results summary
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: 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
Trial description: Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Non-randomized
Primary outcomes:

Steady state area under the curve from 0 to 24 hours (h) of lamotrigine (AUC 0-24) at indicated time points

Timeframe: Day 14, 15, 28 and 29

Maximum observed serum concentration (Cmax) of lamotrigine at indicated time points

Timeframe: Day 14, 15, 28 and 29

Pre-dose serum concentration (Ct [approximate Cmin]) of lamotrigine at indicated time points

Timeframe: Day 14, 15, 28 and 29

Secondary outcomes:

Time to maximum serum concentration (Tmax) of lamotrigine at indicated time points

Timeframe: Day 14, 15, 28, 29

Fluctuation index of lamotrigine at indicated time points

Timeframe: Day 14, 15, 28, 29

Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Up to follow-up period (approximately 5 weeks)

Change from Baseline in Systolic Blood Pressure and Diastolic Blood Pressure

Timeframe: Baseline (Screening, Visit 1, Day 0) and Visit 3 (Day 14 or 15), Visit 5 (Day 28 or 29) and Visit 6 (Day 35)

Change from Baseline in heart rate

Timeframe: Baseline (Screening, Visit 1, Day 0) and Visit 3 (Day 14 or 15), Visit 5 (Day 28 or 29) and Visit 6 (Day 35)

Change from Baseline in weekly seizure frequency during each of the study phases

Timeframe: Baseline (Screening, Visit 1, Day 0) and Visit 3 (Day 14 or 15), Visit 5 (Day 28 or 29) and Visit 6 (Day 35)

Investigator’s Assessment of Seizure Frequency during each of the study phases

Timeframe: Visit 3 (Day 14 or 15), Visit 5 (Day 28 or 29) and Visit 6 (Day 35)

Participant preference at End of Baseline and XR Treatment Phases

Timeframe: Visit 5 (Day 28 or 29) and Visit 6 (Day 35)

Interventions:
  • Drug: lamotrigine extended-release
    • Enrollment:
    44
    Primary completion date:
    2006-13-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    D.J. Tompson, I. Ali, R. Oliver-Willwong, S. Job, L. Zhu, F. Lemme, A.E. Hammer, A. Vuong, J.A. Messenheimer Steady-state Pharmacokinetics of Lamotrigine when Converting from a Twice-daily Immediate-release to a Once-daily Extended-release Formulation in Subjects with Epilepsy (The COMPASS Study). Epilepsia 2008;49;410-417
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    October 2005 to June 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    13+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Confident diagnosis of epilepsy.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23219
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lexington, Kentucky, United States, 40536-0284
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37232
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02215
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Anniston, Alabama, United States, 36207
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Sun City, Arizona, United States, 85351
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 12 Results

    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-13-06
    Actual study completion date
    2006-13-06

    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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