Last updated: 11/04/2018 08:39:15

Pediatric Epilepsy Study in Subjects 1-24 Months

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GSK study ID
LAM20007
See study documents
Clinicaltrials.gov ID
NCT00044278
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: An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive subjects (1-24 months of age)
Trial description: This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation

Timeframe: Up to 50 weeks

Change from baseline in vital signs -heart rate (HR)

Timeframe: Baseline and up to 24 months

Change from baseline in vital signs - body weight

Timeframe: Baseline and up to 24 months

Change from baseline in vital signs - height

Timeframe: Baseline and up to 24 months

Change from baseline in vital signs – head circumference

Timeframe: Baseline and up to 24 months

Change from baseline in clinical chemistry parameters including Albumin and Total protein

Timeframe: Baseline and up to 24 months

Change from baseline in clinical chemistry parameters including alkaline phosphatase (ALP), alanine transaminase (ALT), and aspartate aminotransferase (AST)

Timeframe: Baseline and up to 24 months

Change from baseline in clinical chemistry parameters including total bilirubin and creatinine

Timeframe: Baseline and up to 24 months

Change from baseline in clinical chemistry parameters including glucose, potassium, sodium and urea

Timeframe: Baseline and up to 24 months

Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC)

Timeframe: Baseline and up to 24 months

Change from baseline in Hemoglobin

Timeframe: Baseline and up to 24 months

Change from baseline in Mean corpuscular hemoglobin (MCH)

Timeframe: Baseline and up to 24 months

Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)

Timeframe: Baseline and up to 24 months

Change from baseline in mean corpuscular volume (MCV)

Timeframe: Baseline and up to 24 months

Change from baseline in red blood cells (RBC)

Timeframe: Baseline and up to 24 months

Number of participants with treatment emergent neurological abnormalities

Timeframe: Baseline and up to 24 months

Number of participants with treatment emergent clinically significant electrocardiogram (ECG) abnormalities

Timeframe: Baseline and up to 24 months

Number of participants with potential clinically significant hematology abnormalities

Timeframe: Baseline and up to 24 months

Number of participants with potential clinically significant clinical chemistry abnormalities

Timeframe: Baseline and up to 24 months

Number of participants with potential clinically significant vital signs abnormalities

Timeframe: Baseline and up to 24 months

Secondary outcomes:

Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase

Timeframe: Up to 48 Weeks

Investigator’s overall assessment of the participants' clinical status at the last visit while on study drug

Timeframe: Termination visit (last visit while on study drug)

Mean Maximal plasma concentration (Cmax) of LTG in serum of Lamicital -naïve participants

Timeframe: pre-dose (0.0) and at 1, 2, 3, 4, 6 and 8 hours after dose.

Mean Cmax of LTG in saliva of Lamicital -naïve participants

Timeframe: Pre-dose and at 1, 2, 3, 4, 6 and 8 hours after dose.

Median time to maximal serum or plasma concentration (tmax) of LTG in serum of LTG-naïve participants

Timeframe: Pe-dose (0.0) and at 1, 2, 3, 4, 6 and 8 hours after dose.

Median tmax of LTG in saliva of LTG-naïve participants

Timeframe: Pre-dose (0.0) and at 1, 2, 3, 4, 6 and 8 hours after dose

Mean area under the concentration-time curve over the dosing interval 0 to 8 hours (AUC0-8) of lamotrigine in serum

Timeframe: Pre-dose (0.0) and at 1, 2, 3, 4, 6 and 8 hours after dose

Mean AUC0-8 of LTG in saliva of LTG-naïve participants

Timeframe: Pre-dose (0.0) and at 1, 2, 3, 4, 6 and 8 hours after dose

Mean steady state apparent clearance (CLss/F) of lamotrigine in serum

Timeframe: Pre-dose (0.0) and at 1, 2, 3, 4, 6 and 8 hours after dose

Mean steady state apparent clearance per weight (CLss/F/BW) of lamotrigine in serum

Timeframe: Pre-dose (0.0) and at 1, 2, 3, 4, 6 and 8 hours after dose

Interventions:
  • Drug: lamotrigine
    • Enrollment:
    204
    Primary completion date:
    2006-27-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    September 2000 to June 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    1 - 24 months
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for LAMICTAL naive subjects as follows:
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for LAMICTAL naive subjects as follows:
    • A confident diagnosis of epilepsy.
    • 4 or more partial seizures per month.
    • current treatment with 1 or 2 anti-epileptic drugs. Exclusion criteria:
    • Has seizures not related to epilepsy.
    • Has a surgically implanted and functioning vagal nerve stimulator.
    • Has previously been treated with lamotrigine.
    • Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the ketogenic diet.
    • Use of experimental medication within 30 days of enrollment.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Kansas City, Missouri, United States, 64108
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15213-2583
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90095
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Augusta, Georgia, United States, 30912
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Washington, District of Columbia, United States, 20010
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 69 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
    2006-27-06
    Actual study completion date
    2006-27-06

    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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