Trial record 3 of 334 for:    meningitis

WEUSKOP6166: Lamotrigine and Aseptic Meningitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01657864
First received: August 2, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Epilepsy
Drug: Lamotrigine

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: WEUSKOP6166: Prevalence of Aseptic Meningitis Among Lamotrigine Users

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 1
Study Start Date: May 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with aseptic meningitis
All patients of the study population with a record/diagnosis of aseptic meningitis during the study period
Drug: Lamotrigine
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
Drug: Lamotrigine
Lamotrigine is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  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: NCT01657864

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01657864     History of Changes
Other Study ID Numbers: 117051, WEUSKOP6166
Study First Received: August 2, 2012
Last Updated: August 2, 2012
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
Aseptic Meningitis
Epidemiology
Bipolar Disorder
Lamotrigine
Epilepsy

Additional relevant MeSH terms:
Meningitis
Meningitis, Aseptic
Meningitis, Viral
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Virus Diseases
Lamotrigine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
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 July 31, 2014