Last updated: 11/03/2018 13:27:38

Drug Use Investigation for LAMICTAL

GSK study ID
112727
See study documents
Clinicaltrials.gov ID
NCT01376180
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: Drug Use Investigation for LAMICTAL
Trial description: The purpose of this study is to grasp actual status of usage of lamotrigine tablet and to collect information for using lamotrigine tablet effectively and safely as well as to grasp onset status of adverse events in pediatric subjects, geriatric subjects, pregnant women, subjects with poor renal and hepatic functions.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The number of adverse events in Japanese subjects with epilepsy treated with lamotrigine tablet

Timeframe: 6 months

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Lamotrigine
    • Enrollment:
    3000
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Sunao Kaneko, Yushi Inoue, Masafumi Iijima, Atsuko Ishida, Shogo Inoshiri. Drug Use Investigation of Lamotrigine Tablets in Patients with Epilepsy - Results of Interim Analysis -. 2011;60(3):9-35.
    Sunao Kaneko, Atsuko Ishida, Hirofumi Ozeki, Shinya Nachi,Terufumi Hara. Evaluation of the Safety and Efficacy of Lamotrigine (LTG) in Clinical Practice in Patients with Epilepsy. J Clin Therapeut Med. 2017;33(3):255-276.
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    December 2008 to August 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Subjects with epilepsy having the following seizure types.
    • Partial seizures (including secondary generalized seizures)
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with epilepsy having the following seizure types.
    • Partial seizures (including secondary generalized seizures)
    • Tonic-clonic seizures
    • Generalized seizures of Lennox-Gastaut syndrome
    Exclusion criteria:
    • None

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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
    2016-29-08

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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