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Drug Use Investigation for LAMICTAL

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01376180
First received: June 16, 2011
Last updated: June 5, 2014
Last verified: June 2014

June 16, 2011
June 5, 2014
December 2008
March 2015   (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 ] [ Designated as safety issue: No ]
The number of adverse events in Japanese subjects with epilepsy treated with lamotrigine tablet [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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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Observational
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
Epilepsy
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
May 2016
March 2015   (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

Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01376180
112727
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP