- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01657864
WEUSKOP6166: Lamotrigine and Aseptic Meningitis
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
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Epilepsy
- Meningitis
- Meningitis, Aseptic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anticonvulsants
- Sodium Channel Blockers
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Lamotrigine
Other Study ID Numbers
- 117051
- WEUSKOP6166 (OTHER: GSK)
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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