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Drug Use Investigation for LAMICTAL

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ClinicalTrials.gov Identifier: NCT01376180
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : November 9, 2016
Information provided by (Responsible Party):

June 16, 2011
June 20, 2011
November 9, 2016
December 2008
August 2016   (Final data collection date for primary outcome measure)
The number of adverse events in Japanese subjects with epilepsy treated with lamotrigine tablet [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01376180 on ClinicalTrials.gov Archive Site
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Drug Use Investigation for LAMICTAL
Drug Use Investigation for LAMICTAL
The purpose of this study is to grasp actual status of usage of lamotrigine tablet and to collect information for using lamotrigine tablet effectively and safely as well as to grasp onset status of adverse events in pediatric subjects, geriatric subjects, pregnant women, subjects with poor renal and hepatic functions.
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Time Perspective: Prospective
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Probability Sample

Subjects with epilepsy having the following seizure types.

  • partial seizures (including secondary generalized seizures)
  • tonic-clonic seizures
  • generalized seizures of Lennox-Gastaut syndrome
Drug: Lamotrigine
Administered according to the prescribing information in the locally approved label by the authorities
Subjects prescribed lamotrigine tablet
Subjects with epilepsy prescribed lamotrigine tablet during study period
Intervention: Drug: Lamotrigine
Sunao Kaneko, Yushi Inoue, Masafumi Iijima, Atsuko Ishida, Shogo Inoshiri. Drug Use Investigation of Lamotrigine Tablets in Patients with Epilepsy - Results of Interim Analysis -. 2011;60(3):9-35.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2016
August 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with epilepsy having the following seizure types.
  • Partial seizures (including secondary generalized seizures)
  • Tonic-clonic seizures
  • Generalized seizures of Lennox-Gastaut syndrome

Exclusion Criteria:

- None

Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
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Study Director: GSK Clinical Trials GlaxoSmithKline
November 2016