WEUSKOP6166: Lamotrigine and Aseptic Meningitis

NCT ID: NCT01657864

Last Updated: 2012-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-07-31

Brief Summary

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.

Conditions

Epilepsy

Keywords

Aseptic Meningitis; Epidemiology; Bipolar Disorder; Lamotrigine; Epilepsy

Study Design

• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with aseptic meningitis

All patients of the study population with a record/diagnosis of aseptic meningitis during the study period

Lamotrigine

Intervention Type: DRUG

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

Intervention Type: DRUG

Lamotrigine is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder

Interventions

Lamotrigine

Lamotrigine is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

WEUSKOP6166

Identifier Type: OTHER

Identifier Source: secondary_id

117051

Identifier Type: -

Identifier Source: org_study_id