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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2010-12-07
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
Completed
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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