Last updated: 02/11/2021 09:10:07

LAMICTAL Special Drug Use Investigation(mono-therapy for Typical Absence Seizure)

GSK study ID
202026
See study documents
Clinicaltrials.gov ID
Not applicable
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: LAMICTAL Special Drug Use Investigationļ¼ˆmono-therapy for Typical Absence Seizureļ¼‰
Trial description: This post-marketing surveillance (PMS) study is conducted to assess the information about safety and effectiveness in pediatric epilepsy patients (aged less than 15 years) with typical absence seizures in routine medical practice. LAMICTAL is a registered trademark of the GSK group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The incidence of adverse drug reactions

Timeframe: 6 months

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Lamotrigine tablets
    • Enrollment:
    20
    Primary completion date:
    2019-05-09
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    June 2016 to September 2019
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    15+ years
    Accepts healthy volunteers
    Not applicable
    • Pediatric patients with typical absence seizures
    • Pediatric patients who receive lamotrigine monotherapy for the first time
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Pediatric patients with typical absence seizures
    • Pediatric patients who receive lamotrigine monotherapy for the first time
    Exclusion criteria:
    • None

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    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
    2019-05-09
    Actual study completion date
    2019-05-09

    Plain language summaries

    Not applicable. GSKā€™s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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