Special Drug Use Investigation for LAMICTAL® (Long Term)
- Registration Number
- NCT01863602
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 850
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects prescribed lamotrigine tablets Lamotrigine tablets Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome to whom lamotrigine tablets are administered.
- Primary Outcome Measures
Name Time Method The incidence of adverse drug reactions 1 year Occurrence of skin disorder after the start of treatment 1 year Presence or absence of skin disorder and its details after the start of treatment will be investigated as a priority investigation item
- Secondary Outcome Measures
Name Time Method Overall improvement of subjects' symptoms 1 year Investigators will assess the overall improvement as "remarkably improved". "improved", "slightly improved", "unchanged" or "worsened" on the basis of the degree of change in frequency of seizures, strength, span and other related symptoms.