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
    Contact us
    Contact us
    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
    Contact us
    Location
    GSK Investigational Site
    Augusta, Georgia, United States, 30912
    Status
    Study Complete
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    Showing 1 - 6 of 87 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

    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.

    Additional information about the trial

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