WEUSKOP6166: Lamotrigine and Aseptic Meningitis

August 2, 2012 updated by: GlaxoSmithKline

WEUSKOP6166: Prevalence of Aseptic Meningitis Among Lamotrigine Users

The objective of the study is to quantify the number of cases of aseptic meningitis among users of Lamotrigine. This study is a cross-sectional study design using data on lamotrigine patients within the Thomson Reuters MarketScan® Commercial database (MarketScan database). The MarketScan database is a US-based insurance claims database representative of a US insured population and includes supplemental datao n Medicare patients. This cross-sectional study will evaluate the number of cases of aseptic meningitis among lamotrigine users during the duration of lamotrigine therapy, with an extended exposure window of 30 days after completing therapy.

The MarketScan® Database is an US insurance claims database that is held in-house at GSK, which can be interrogated to examine rates of prescribing and medical conditions that can be captured via ICD-9 diagnoses codes. The MarketScan database captures person-specific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. The annual medical databases include private sector health data from approximately 100 payers. In 2011, there were approximately 35 million patients on the database. The Commercial Claims and Encounters Database represents the medical experience of insured employees and their dependents for active employees, early retirees, COBRA continues, and their dependents insured by employer-sponsored plans (i.e., non-Medicare eligibles). In addition, a linked Medstat Medicare database contains predominantly fee-for-service plan data in insurance plans where both the Medicare-paid amounts and the employer-paid amounts were available and evident on the claims.The data are HIPAA compliant thus all patients have been anonymized.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population for this study includes new user of lamotrigine. To be eligible for this study, Patients were required to use lamotrigine for epilepsy or bipolar disorder. Patients must have at least 180 days history on the database prior to the index of lamotrigine use. Patients must have medical and pharmacy coverage throughout the study.

Description

Inclusion Criteria:

  • Patients must be using lamotrigine for epilepsy or bipolar disorder.
  • Patients must have at least 180 days history on the database prior to the index of lamotrigine use.
  • Patients must have medical and pharmacy coverage throughout the study, with no gaps in eligibility.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with aseptic meningitis
All patients of the study population with a record/diagnosis of aseptic meningitis during the study period
Lamotrigine is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder
Patients without aseptic meningitis
All patients of the study population without a record/diagnosis of aseptic meningitis during the study period
Lamotrigine is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aseptic meningitis during the period of time the patient is taking lamotrigine
Time Frame: The period at-risk for aseptic meningitis shall begin with the date of the new prescription for lamotrigine and will end 30 days after the last dose of the drug
The exposure window will be extended by 30 days to be consistent with current pharmacovigilance polices at GSK. Aseptic meningitis coded within this window shall be included in the rate
The period at-risk for aseptic meningitis shall begin with the date of the new prescription for lamotrigine and will end 30 days after the last dose of the drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

August 2, 2012

First Submitted That Met QC Criteria

August 2, 2012

First Posted (ESTIMATE)

August 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2012

Last Update Submitted That Met QC Criteria

August 2, 2012

Last Verified

July 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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