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: May 12, 2016

Last verified: May 2016

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

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

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:	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

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

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
Study First Received:	June 16, 2011
Last Updated:	May 12, 2016
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:


Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases 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

ClinicalTrials.gov processed this record on September 26, 2016

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