Last updated: 11/04/2018 08:42:50

Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug

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GSK study ID
LAM40097
See study documents
Clinicaltrials.gov ID
NCT00043901
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: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Evaluation of Lamotrigine Adjunctive Therapy in Subjects wtih Primary Generalized Tonic-Clonic Seizures
Trial description: The purpose of this study is to evaluate the effectiveness and safety of an investigational new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC) seizures.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: lamotrigine
    • Enrollment:
    141
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Double-blind, placebo-controlled, study of lamotrigine in primary generalized tonic-clonic seizures. Biton V, Sackellares C, Vuong A, Hammer A, Barrett P, Messenheimer J. Neurology 2005;65:1737-1743.
    Medical condition
    Epilepsy, Tonic-Clonic
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    December 2000 to March 2005
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    2+ years
    Accepts healthy volunteers
    No
    • Weigh at least 13kg.
    • Have a confident diagnosis of epilepsy with primary generalized tonic-clonic (PGTC) seizures with or without other generalized seizure types.
    • A history of partial seizures or interictal expression of partial seizures as evidenced by electroencephalogram.
    • Have Lennox-Gastaut syndrome.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Weigh at least 13kg.
    • Have a confident diagnosis of epilepsy with primary generalized tonic-clonic (PGTC) seizures with or without other generalized seizure types.
    • Currently being treated with an antiepileptic drug(s) (AED).
    • Benzodiazepines are allowed with some frequency restrictions.
    • Vagus nerve stimulation is allowed if in place for at least 6 months prior to starting the study with no changes to the settings having occured during the month immediately prior to starting the study, and if no changes will occur during all phases of the study.
    • History of primary generalized tonic-clonic seizures with no focal onset.
    • Have at least 1 primary generalized tonic-clonic (PGTC) seizure during the 8 consecutive weeks prior to the baseline period of the study.
    • Have at least 3 PGTC seizures occur anytime during the 8-week baseline phase of the study.
    • Females must agree to acceptable form of birth control.
    Exclusion criteria:
    • A history of partial seizures or interictal expression of partial seizures as evidenced by electroencephalogram.
    • Have Lennox-Gastaut syndrome.
    • Currently using or has previously used the drug being studied.
    • Is abusing alcohol and/or other substance(s).
    • Has taken an investigational drug during the 30 days prior to the study or plans to take an investigational drug anytime during the study.
    • Is receiving chronic (long-term) treatment with any medication that could influence seizure control.
    • Follows the ketogenic diet.
    • Is planning surgery to control seizures during the study.
    • Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormality.
    • Has any clinically significant heart, kidney, or liver condition, or a condition that affects how drugs are absorbed, distributed, metabolized, or removed from the body.

    Trial location(s)

    Location
    Status
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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, 46202 - 5111
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Northridge, California, United States, 91325
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fort Worth, Texas, United States, 76104
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Cherry Hill, New Jersey, United States, 8034
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Augusta, Georgia, United States, 30912
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Springfield, Illinois, United States, 62702
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Crestview Hills, Kentucky, United States, 41017
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Alabaster, Alabama, United States, 35007
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Cloud, Minnesota, United States, 56303
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33125
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44195
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Canton, Ohio, United States, 44718
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Springfield, Missouri, United States, 65807
    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
    Bakersfield, California, United States, 93309
    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
    St. Louis, Missouri, United States, 63110-1093
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33607-6350
    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
    San Isidro, Lima, Peru, Lima 27
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lexington, Kentucky, United States, 40536-0284
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30342
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30338
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Greenville, North Carolina, United States, 27834
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newton, Massachusetts, United States, 02459
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Gainsville, Florida, United States, 32611
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37212
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Marshfield, Wisconsin, United States, 54449
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Orlando, Florida, United States, 32835
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sacramento, California, United States, 95871
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Danville, Pennsylvania, United States, 17822-4201
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75235
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Detroit, Michigan, United States, 48202
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44106
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Medford, New Jersey, United States, 08055
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Winston-Salem, North Carolina, United States, 27157
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tallahassee, Florida, United States, 32308
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Tacoma, Washington, United States, 98405
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Lexington, Kentucky, United States, 40503
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Buenos Aires, Buenos Aires, Argentina, 1181
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Albany, New York, United States, 12205
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Boise, Idaho, United States, 83712
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wichita, Kansas, United States, 67214
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Irvine, California, United States, 92618
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Sharon, Massachusetts, United States, 02067
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Toledo, Ohio, United States, 43614-5809
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New Brunswick, New Jersey, United States, 8903
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Valparaiso, Valparaíso, Chile, 2341131
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Idaho Falls, Idaho, United States, 83404
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Germantown, Tennessee, United States, 38138
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mount Vernon, New York, United States, 10550
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Mobile, Alabama, United States, 36693
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Farmington Hills, Michigan, United States, 48334
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Washington, District of Columbia, United States, 20037
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Natrona Heights, Pennsylvania, United States, 15065
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84113
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84102
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlotte, North Carolina, United States, 28207
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Danville, Virginia, United States, 24541
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97201-2984
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Buenos Aires, Buenos Aires, Argentina, 1221
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Buenos Aires, Buenos Aires, Argentina, C1428AQK
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60637-1470
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33136
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Capital Federal, Argentina
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Arlington, Texas, United States, 76015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55422
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Kansas City, Missouri, United States, 64108
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Madison, Wisconsin, United States, 53715
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bennington, Vermont, United States, 05201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Asheville, North Carolina, United States, 28801
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Memphis, Tennessee, United States, 38119
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89102
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Panama City, Florida, United States, 32405
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spartanburg, South Carolina, United States, 29303
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Northport, Alabama, United States, 35476
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Medford, Oregon, United States, 97504-8456
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73104
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27607
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Santiago, Región Metro De Santiago, Chile
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Denver, Colorado, United States, 80218
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Palm Beach, Florida, United States, 33407
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newport News, Virginia, United States, 23601
    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-17-03

    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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