Special Drug Use Investigation for LAMICTAL® (Long Term)
|ClinicalTrials.gov Identifier: NCT01863602|
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : November 9, 2016
|Condition or disease||Intervention/treatment|
|Epilepsy||Drug: Lamotrigine tablets|
|Study Type :||Observational|
|Actual Enrollment :||850 participants|
|Official Title:||Special Drug Use Investigation for LAMICTAL (Long Term)|
|Study Start Date :||April 2009|
|Primary Completion Date :||July 2016|
|Study Completion Date :||July 2016|
Subjects prescribed lamotrigine tablets
Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome to whom lamotrigine tablets are administered.
Drug: Lamotrigine tablets
Administered for long-term according to the prescribing information in the locally approved label by the authorities.
- The incidence of adverse drug reactions [ Time Frame: 1 year ]
- Occurrence of skin disorder after the start of treatment [ Time Frame: 1 year ]Presence or absence of skin disorder and its details after the start of treatment will be investigated as a priority investigation item
- Overall improvement of subjects' symptoms [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863602
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|