Last updated: 11/03/2018 13:27:38
Drug Use Investigation for LAMICTAL
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
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
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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