Last updated: 11/07/2018 05:01:39
Special Drug Use Investigation for LAMICTAL® (Long term)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
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
2016-28-07
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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