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
    • Inclusion criteria:
    • Confident diagnosis of epilepsy
    Inclusion and exclusion criteria
    Inclusion 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
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Kansas City, Missouri, United States, 64111
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53226
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Scarborough, Maine, United States, 4074
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Columbia, Tennessee, United States, 38401
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40202
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Terminated/Withdrawn
    Contact us
    Showing 1 - 6 of 63 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
    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.

    Additional information about the trial

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