Last updated: 11/04/2018 08:38:37

Pediatric Epilepsy Trial in Subjects 1-24 Months

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GSK study ID
LAM20006
See study documents
Clinicaltrials.gov ID
NCT00043875
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 Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric Age Subjects (1-24 months)
Trial description: This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase.

Timeframe: 36 Months

Secondary outcomes:

Time to escape patterns in Double-Blind phase. Reduction in partial seizure frequency at end of Open-Label Phase. Investigators' global evaluation of subjects' status at end of Open-Label and Double-Blind Phases; Standard pharmacokinetics; Adverse Events

Timeframe: 36 Months

Interventions:
  • Drug: lamotrigine
    • Enrollment:
    177
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    May 2000 to November 2003
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    1 - 24 months
    Accepts healthy volunteers
    No
    • INCLUSION CRITERIA:
    • Have a confident diagnosis of epilepsy
    Inclusion and exclusion criteria
    Inclusion criteria:
    • INCLUSION CRITERIA:
    • Have a confident diagnosis of epilepsy
    • Must be experiencing 4 or more reliably detectable partial seizures per month while receiving at least 1 anti-epileptic drug (AED)
    • Must weigh at least 7 lbs if currently receiving enzyme inducing antiepileptic drugs (EIADs) OR weigh at least 15 lbs if currently receiving non-enzyme inducing antiepileptic drugs (non-EIADs)
    • Have no underlying chronic metabolism problems
    • Have normal lab results
    • Have a normal electrocardiogram (ECG) EXCLUSION CRITERIA:
    • Have a diagnosis of severe, progressive myoclonus.
    • Have seizures not related to epilepsy.
    • Have previously demonstrated sensitivity or allergic reaction to the study drug or its related compounds.
    • Have progressive or unstable condition of the nervous system.
    • Used experimental medication within 30 of enrollment into the study.
    • Have any significant, chronic heart, kidney, liver or stomach/intestinal (GI) condition.
    • Current use of the medication felbamate.
    • Current use of adrenocorticotrophic hormone (ACTH).
    • Following a ketogenic diet.
    • Receiving vagal nerve stimulation (VNS).

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Budapest, Hungary, 1094
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kaunas, Lithuania, LT-50009
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Porto, Portugal, 4099-001
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Norfolk, Virginia, United States, 23510
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Bratislava, Slovakia, 833 40
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Stanford, California, United States, 94305-5235
    Status
    Study Complete
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    Showing 1 - 6 of 65 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
    2003-25-11

    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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