Special Drug Use Investigation for LAMICTAL (Lamotrigine) Tablets for Long-term Use
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Special Drug Use Investigation for LAMICTAL (Lamotrigine) Tablets for Long-term Use|
- The incidence of adverse drug reactions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Occurrence of skin disorder after the start of treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01863602
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|