Epilepsy
Conditions
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.
Interventions
Administered for long-term according to the prescribing information in the locally approved label by the authorities.
Sponsors
GlaxoSmithKline
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed