Clinical & Economic Burden of Uncontrolled Epilepsy: Analyses From a

Status Completed

Clinical Trial Summary

Antiepileptic drugs (AEDs) are the main therapeutic option for patients with epilepsy; however, complete seizure control remains elusive for many patients. Uncontrolled or refractory epilepsy is associated with a higher risk of mortality, physical injuries, and depression or anxiety compared with patients with controlled epilepsy. Higher resource utilization for patients with poor control is likely to be associated with higher economic costs. While diagnostic criteria for uncontrolled epilepsy are debated by neurologists, recent studies suggest that a diagnosis of uncontrolled epilepsy requires 1.) at least one seizure per month and 2.) a history of drug failures.

The objective of this study is to identify patients with uncontrolled epilepsy in both a Medicaid database and a private health plan database, to describe patient characteristics and AED treatment patterns between cohorts of patients with uncontrolled versus well-controlled epilepsy, and to evaluate the economic burden of uncontrolled versus well-controlled epilepsy.

For this evaluation, the data sources are medical and pharmacy claims in Medicaid databases from Florida (Third quarter 1997 to second quarter 2008), Iowa (First quarter 1998 to second quarter 2006), Kansas (First quarter 2001 to second quarter 2009), Missouri (First quarter 1997 to second quarter 2008) and New Jersey (First quarter 1997 to fourth quarter 2008) and medical and pharmacy claims in an private health plan database.

The study design is a retrospective, longitudinal, matched-cohort study. Eligible patient records will be assigned to one of three mutually-exclusive cohorts: uncontrolled epilepsy (at least 2 consecutive changes in AED therapy in at least 30 days, and at least 1 epilepsy-related inpatient or emergency department (ED) visit within 365 days), well-controlled epilepsy (no AED changes and no epilepsy-related inpatient or ED visits), and intermediate epilepsy (not classified as uncontrolled or well-controlled).

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Epilepsy

Clinical Trial Details

NCT number	NCT01390909
Study type	Observational
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	N/A
Start date	May 2010
Completion date	January 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04595513` - Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants	Phase 1/Phase 2
Completed	`NCT02909387` - Adapting Project UPLIFT for Blacks in Georgia	N/A
Completed	`NCT05552924` - Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients	N/A
Terminated	`NCT01668654` - Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS	Phase 3
Not yet recruiting	`NCT05068323` - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients	N/A
Completed	`NCT03994718` - Creative Arts II Study	N/A
Recruiting	`NCT04076449` - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Completed	`NCT00782249` - Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy	N/A
Completed	`NCT03683381` - App-based Intervention for Treating Insomnia Among Patients With Epilepsy	N/A
Recruiting	`NCT05101161` - Neurofeedback Using Implanted Deep Brain Stimulation Electrodes	N/A
Active, not recruiting	`NCT06034353` - Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients	N/A
Recruiting	`NCT05769933` - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Not yet recruiting	`NCT06408428` - Glioma Intraoperative MicroElectroCorticoGraphy	N/A
Not yet recruiting	`NCT05559060` - Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
Completed	`NCT02952456` - Phenomenological Approach of Epilepsy in Patients With Epilepsy
Completed	`NCT02646631` - Behavioral and Educational Tools to Improve Epilepsy Care	N/A
Completed	`NCT02977208` - Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use	Phase 4
Recruiting	`NCT02539134` - TAK-935 Multiple Rising Dose Study in Healthy Participants	Phase 1
Terminated	`NCT02757547` - Transcranial Magnetic Stimulation for Epilepsy	N/A
Completed	`NCT02491073` - Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms