Epilepsy Clinical Trial
Official title:
WEUSKOP6166: Prevalence of Aseptic Meningitis Among Lamotrigine Users
Verified date | July 2012 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: No Health Authority |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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: |
Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aseptic meningitis during the period of time the patient is taking lamotrigine | 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 | Yes |
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