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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
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Epilepsy Drug: Lamotrigine

Study Design
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Study Type : Observational
Actual Enrollment : 3000 participants
Time Perspective: Prospective
Official Title: Drug Use Investigation for LAMICTAL
Study Start Date : December 2008
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Lamotrigine
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The number of adverse events in Japanese subjects with epilepsy treated with lamotrigine tablet [ Time Frame: 6 months ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Criteria

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376180


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:
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
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016

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