Last updated: 01/31/2020 13:30:14

Special Drug Use Investigation of LAMICTAL Tablets in Patients with Epilepsy (Investigation on Switching to Monotherapy)

GSK study ID
201365
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: Special Drug Use Investigation of LAMICTAL Tablets in Patients with Epilepsy (Investigation on Switching to Monotherapy)
Trial description: This post-marketing surveillance (PMS) study is conducted to collect safety and effectiveness data in subjects with epilepsy who have been receiving lamotorigine in combination with sodium valporate or carbamazepine and switched to lamotorigine monotherapy treatment. 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: From the start of dose reduction of VPA or CBZ to 3 months after the start of lamotorigine monotherapy

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Lamotorigine tablets
    • Enrollment:
    316
    Primary completion date:
    2016-12-09
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Atsuko Ishida, Hirofumi Ozeki, Shinya Nachi, Terufumi Hara, Ryoko Sato. Conversion from Combination Therapy to Monotherapy of Lamotrigine in Adult Epilepsy Patients Aged 15 Years or Older in Daily Clinical Practice. J Clin Therapeut Med No. 2017;33(6):503-516
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    November 2014 to September 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    15+ years
    Accepts healthy volunteers
    none
    • Subjects with epilepsy
    • Subjects aged 15 years or older
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with epilepsy
    • Subjects aged 15 years or older
    • Subjects who have been treated with lamotorigine in combination with sodium valporate or carbamazepine and switch the treatment to lamotorigine monotherapy
    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
    2016-12-09
    Actual study completion date
    2016-12-09

    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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