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Drug Use Investigation for LAMICTAL (Lamotrigine)

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: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Epilepsy
 Drug: Lamotrigine

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

Resource links provided by NLM:

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

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: April 2016
Estimated Primary Completion Date: September 2014 (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

  Eligibility

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

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376180     History of Changes
Other Study ID Numbers: 112727
Study First Received: June 16, 2011
Last Updated: March 7, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lamotrigine
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013