Drug Use Investigation for LAMICTAL

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: June 16, 2011
Last updated: May 12, 2016
Last verified: May 2016
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.

Condition Intervention
Drug: Lamotrigine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Drug Use Investigation for LAMICTAL

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of adverse events in Japanese subjects with epilepsy treated with lamotrigine tablet [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: December 2008
Estimated Study Completion Date: August 2016
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed lamotrigine tablet
Subjects with epilepsy prescribed lamotrigine tablet during study period
Drug: Lamotrigine
Administered according to the prescribing information in the locally approved label by the authorities


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with epilepsy having the following seizure types.

  • partial seizures (including secondary generalized seizures)
  • tonic-clonic seizures
  • generalized seizures of Lennox-Gastaut syndrome

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01376180

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

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.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376180     History of Changes
Other Study ID Numbers: 112727 
Study First Received: June 16, 2011
Last Updated: May 12, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Calcium Channel Blockers
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sodium Channel Blockers
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on May 26, 2016