Last updated: 11/07/2018 17:28:48

Lamotrigine Extended-Release In Elderly Patients With Epilepsy

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GSK study ID
LEP105972
See study documents
Clinicaltrials.gov ID
NCT00516139
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: Lamotrigine Extended-Release in Elderly Patients with Epilepsy
Trial description: This study is being conducted to determine the safety and tolerability of lamotrigine (LTG) in elderly patients with epilepsy. This study will be carried out using an extended-release formulation of lamotrigine (LTG-XR) that will allow once-a-day dosing.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants with any serious adverse event (SAE) and any non-serious adverse event

Timeframe: From Baseline (Week 0) until 3 weeks after the end of treatment (Week 30 or 33)

Secondary outcomes:

Percent change from Baseline (BL) in weekly seizure (sz.) frequency for all partial seizures during each phase of the study

Timeframe: Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (Week 30 or 33)

Number of participants with the indicated change from Baseline in weekly seizure frequency during each phase of the study

Timeframe: Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization (Adj O) Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (ET, Week 30 or 33)

Number of seizure-free participants at Baseline who remained seizure-free throughout the entire treatment period

Timeframe: Week 30 or 33

Number of participants with changes from Baseline in seizure severity in the indicated categories, as measured by the Investigator's Global Evaluation (IGE) scale

Timeframe: Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])

Number of participants with changes from Baseline in overall clinical status in the indicated categories, as measured by the IGE scale

Timeframe: Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])

Change from Baseline in systolic and diastolic blood pressure (BP) at the indicated time points in the study

Timeframe: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])

Change from Baseline in the height at the indicated time points in the study

Timeframe: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])

Change from Baseline in the weight at the indicated time points in the study

Timeframe: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])

Change from Baseline in the basophil, eosinophil, hemoglobin, lymphocyte, monocyte, absolute neutrophil count (ANC), platelet count, and white blood cell (WBC) count at the indicated time points in the study

Timeframe: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)

Percent change from Baseline in the basophil, eosinophil, hemoglobin, lymphocyte, monocyte, absolute neutrophil count, platelet count, and white blood cell count at the indicated time points in the study

Timeframe: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)

Change from Baseline in the mean corpuscle hemoglobin concentration (MCHC), albumin, and total protein at the indicated time points in the study

Timeframe: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)

Change from Baseline in Mean Corpuscle Hemoglobin (MCH) at the indicated time points in the study

Timeframe: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)

Change from Baseline in Mean Corpuscle Volume (MCV) at the indicated time points in the the study

Timeframe: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)

Change from Baseline in red blood cell (RBC) count at the indicated time points in the study

Timeframe: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)

Change from Baseline in Alkaline Phosphatase (Alk P), Alanine Amino Transferase (Ala AT), and Aspartate Amino Transferase (Asp AT) at the indicated time points in the study

Timeframe: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)

Change from Baseline in direct bilirubin (DB), total bilirubin (TB), and creatinine at the indicated time points in the study

Timeframe: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)

Change from Baseline in cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, glucose, potassium, sodium, triglycerides, and urea/blood urea nitrogen (BUN) at the indicated time points

Timeframe: Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)

Serum LTG concentrations at different LTG doses based on the concomitant AED groups: neutral (without known enzyme-inducing AED [EIAED], valproate [VPA]) with EIAED, and with VPA

Timeframe: Weeks 4, 7, 11, 15, 20, 24, and 28

Apparent clearance (CL/F) based on the concomitant AED groups: neutral, with EIAED, and with VPA

Timeframe: Weeks 4, 7, 11, 15, 20, 24, and 28

Apparent volume of distribution (V/F) for participants in all concomitant AED groups combined: neutral, with EIAED, and with VPA

Timeframe: Weeks 4, 7, 11, 15, 20, 24, and 28

Absorption rate (KA) for participants in all concomitant AED groups combined: neutral, with EIAED, and with VPA

Timeframe: Weeks 4, 7, 11, 15, 20, 24, and 28

Interventions:
  • Drug: Lamotrigine
    • Enrollment:
    122
    Primary completion date:
    2010-12-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Wechsler RT, Leroy R, VanCott A, Hammer AE, Vuong A, Huffman R, VanLandingham K, Messenheimer JA.. Lamotrigine Extended-Release as Adjunctive Therapy with Optional Conversion to Monotherapy in Older Adults with Epilepsy . Epilepsy Res. 2014;108(6):1128-1136.
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    August 2007 to July 2010
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    65+ years
    Accepts healthy volunteers
    No
    • Confident diagnosis of epilepsy
    • Currently treated with one or two antiepileptic medications
    • History of hypersensitivity to lamotrigine
    • Progressive diseases that would interfere with the study objectives
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Confident diagnosis of epilepsy
    • Currently treated with one or two antiepileptic medications
    • Able to complete a seizure diary
    Exclusion criteria:
    • History of hypersensitivity to lamotrigine
    • Progressive diseases that would interfere with the study objectives

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Kansas City, Missouri, United States, 64111
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53226
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Scarborough, Maine, United States, 4074
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbia, Tennessee, United States, 38401
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Burlington, Massachusetts, United States, 01805
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pasadena, California, United States, 91106
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Toledo, Ohio, United States, 43614
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30322
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Temple, Texas, United States, 76508
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gilbert, Arizona, United States, 85234
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Camden, New Jersey, United States, 08103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19102
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37232
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55422
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Paul, Minnesota, United States, 55102
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Wayne, Indiana, United States, 46805
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Schenectady, New York, United States, 12308
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43210
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85003
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30309
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46256
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Springfield, Illinois, United States, 62702
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Newark, Delaware, United States, 19713
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53215
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15240
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Traverse City, Michigan, United States, 49684
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bremerton, Washington, United States, 98310
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32224
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gainesville, Florida, United States, 32610
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Boise, Idaho, United States, 83702
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Henderson, Nevada, United States, 89014
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Summit, New Jersey, United States, 07901
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23298
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Melbourne, Florida, United States, 32901
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Germantown, Tennessee, United States, 38139
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rochester, New York, United States, 14642
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chesterfield, Missouri, United States, 63017
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Wichita, Kansas, United States, 67214
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cedarhurst, New York, United States, 11516
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75230
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32266
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90073
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fullteron, California, United States, 92835
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hopedale, Massachusetts, United States, 01747
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75214
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cordova, Tennessee, United States, 38018
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Sarasota, Florida, United States, 34233
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fresno, California, United States, 93710
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33136
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Madison, Wisconsin, United States, 53715
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newark, New Jersey, United States, 07103
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Suwanee, Georgia, United States, 30024
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ponte Vedra Beach, Florida, United States, 32082
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85013
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19140
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sellersville, Pennsylvania, United States, 18960
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73112
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35294-0021
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Litchfield Park, Arizona, United States, 85340
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Irvine, California, United States, 92618
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fort Collins, Colorado, United States, 80524
    Status
    Study Complete
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    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
    2010-12-07
    Actual study completion date
    2010-12-07

    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.

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