Last updated: 11/04/2018 08:36:56

LAMICTAL (lamotrigine) For The Treatment Of Absence Seizures

Request patient level data
GSK study ID
LAM100118
See study documents
Clinicaltrials.gov ID
NCT00144872
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: Evaluation of lamotrigine in subjects with absence seizures
Trial description: This is an open-label study evaluating the efficacy and safety of lamotrigine (LTG) for the treatment of newly-diagnosed typical absence seizures. Subjects will be children and adolescents < 13 years of age. It will be conducted at multiple sites in the US. The study will consist of 4 phases: Screen Phase (up to 1 week), Baseline Phase (24 hours), Escalation Phase (up to 20 weeks) and Maintenance Phase (12 weeks). Subjects will receive increasing doses of LTG according to the dosing schedule until attaining seizure freedom as confirmed by hyperventilation (HV) for clinical signs and a 1-hr EEG at 2 consecutive weekly visits. At that point, subjects will move into the 12-week Maintenance Phase. Subjects who do not achieve seizure freedom upon reaching the maximum dose (10.2mg/kg/day) with the specified dose escalation will be discontinued from the study. During the Maintenance Phase, the investigators will use their best effort to maintain the subjects at the efficacious dose reached. If the subjects have unacceptable side effects or inadequate seizure control, the doses of study drug can be increased or decreased as specified in the dosing schedule. Safety will be assessed by monitoring adverse events, laboratory assessments, and serum lamotrigine levels. Health outcomes assessments will also be conducted.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

The proportion of subjects with no typical absence seizures for two consecutive weeks as confirmed by hyperventilation (HV) for clinical signs and 1-hour electroencephalogram (EEG)

Timeframe: Up to 8 months

Secondary outcomes:

Freq of seizures pre/post-treatment with lamotrigine, proportion of subjects with >=25, 50 and 75% decrease in seizure frequency, proportion of subjects with >=25, 50 and 75% decrease in clinical signs.

Timeframe: Up to 8 months

Interventions:
  • Drug: Lamotrigine
    • Enrollment:
    54
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Seizure, Absence
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    November 2004 to April 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable - 12 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Newly-diagnosed with absence epilepsy and never been treated with Anti-epileptic drugs (AEDs).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Newly-diagnosed with absence epilepsy and never been treated with Anti-epileptic drugs (AEDs).
    • Diagnosis demonstrated on one of two 5-minute hyperventilation tests.
    • Investigator must judge that the subject and parent/guardian are likely to comply with all study procedures.
    • Parent/guardian must given written informed consent. Subjects who are intellectually able to understand the concepts and procedures of the protocol must give assent by also signing the consent or by signing a separate assent form.
    • Results of all screen assessments are judged to be clinically acceptable to the investigator and do not indicate any reasons why entry into the study would be contraindicated. Exclusion criteria:
    • Seizures are the result of a currently active, known, and identifiable intracerebral lesion.
    • Has partial or generalized tonic-clonic seizures.
    • Has a progressive neurological disorder defined as being unstable for at least 12 weeks prior to the Screen Phase.
    • Has a psychiatric disorder requiring medication, or has had a past psychiatric condition that was both judged to be severe and required hospitalization.
    • Has any clinically significant chronic cardiac, renal, or hepatic medical condition.
    • Has a condition that affects the absorption, distribution, metabolism, or excretion of drugs.
    • Is currently taking any psychoactive drugs to treat hyperactivity disorder or attention deficit disorder.
    • Has taken any investigational drug within 12 weeks prior to the Screen Phase.
    • Is sexually active.
    • Is either pregnant (i.e., confirmed by pregnancy test at Screen) or breastfeeding.
    • Has a clinically significant chronic medical disorder which the investigator and/or GSK medical monitor determine warrants exclusion.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97239
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30342
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98105
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Rochester, New York, United States, 14642
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Newark, New Jersey, United States, 07103
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27607
    Status
    Study Complete
    Contact us

    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
    2006-22-04

    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

    Participate in clinical trial
    Additional information
    Results for study LAM100118 can be found on the GSK Clinical Study Register.
    Click here
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website