Last updated: 11/07/2018 05:01:39

Special Drug Use Investigation for LAMICTAL® (Long term)

GSK study ID
112728
See study documents
Clinicaltrials.gov ID
NCT01863602
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: Special Drug Use Investigation for LAMICTAL (Long term)
Trial description: The objectives of this post-marketing surveillance (PMS) are to grasp the actual use of lamotrigine tablets to collect safety information in the long-term use according to seizure type and concomitant antiepileptic drug (AED), and to confirm its efficacy.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The incidence of adverse drug reactions

Timeframe: 1 year

Occurrence of skin disorder after the start of treatment

Timeframe: 1 year

Secondary outcomes:

Overall improvement of subjects' symptoms

Timeframe: 1 year

Interventions:
  • Drug: Lamotrigine tablets
    • Enrollment:
    850
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Atsuko Ishida, Hirofumi Ozeki, Shinya Nachi, Terufumi Hara, and Ryoko Sato. Evaluation of the Safety and Efficacy of Lamotrigine (LTG) under Actual Long-term Use in Patients with Epilepsy ? Final Report of a Special Drug Use Investigation ?. J Clin Therapeut Med. 2017;33(11):897-913
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    April 2009 to July 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome
    • Subjects who are treated with lamotrigine tablets
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome
    • Subjects who are treated with lamotrigine tablets
    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
    2016-28-07

    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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