Last updated: 01/31/2020 13:30:14
Special Drug Use Investigation of LAMICTAL Tablets in Patients with Epilepsy (Investigation on Switching to Monotherapy)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Case-Only
Primary completion date:
2016-12-09
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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