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

October 4, 2012 updated by: GlaxoSmithKline

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12386

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The electronic records from adult patients with epilepsy who are enrolled in Medicaid in Florida, Iowa, Kansas, Missouri or New Jersey or in a private health plan database. Patient records will be classified into one of three mutually-exclusive cohorts: uncontrolled epilepsy, well-controlled epilepsy, and intermediate epilepsy (not classified as uncontrolled or well-controlled).

Description

Inclusion Criteria:

  • At least 18 years of age at the initiation of anti-epileptic drug (AED) treatment as noted in the database
  • A record of at least one medical visit with a diagnosis of epilepsy (ICD-9-CM 345.xx) or at least two diagnoses of non-febrile convulsions (ICD-9-CM 780.30 or 780.39) occuring more than 30 days apart
  • At least one pharmacy claim for an anti-epileptic drug (AED)
  • Continuous enrollment throughout the observation period (minimum of 365 days). Patients with gaps in Medicaid enrollment will be observed only during their period of continuous enrollment, provided that all the above criteria are met

Exclusion Criteria:

  • Age less than 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Medicaid patients with uncontrolled epilepsy
Database records for patients with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the 365 days
Prescription claim for at least one AED including lamotrigine, tiagabine, pregabalin, ethosuximide, lacosamide, phenytoin, carbamazepine, valproic acid, felbamate, levetiracetam, zonisamide, primidone, oxcarbazepine, vigabatrin, phenobarbital, gabapentin, topiramate.
Other Names:
  • Mysoline® is a registered trademark of Valeant Pharmaceuticals
  • Neurotin® is registered trademark of Pfizer
  • Inc
  • Vimpat® is a registered trademark of UCB Pharma
  • Tegretol® is a registered trademark of Novartis Pharmaceuticals
  • Trileptal® is a registered trademark of Novartis Pharmaceuticals
  • Sabril® is a registered trademark of Lundbeck Inc
  • Felbatol® is a registered trademark of MedPointe
  • Topamax® is a registered trademark of Ortho-McNeill-Janssen Pharmaceuticals
  • Depakote® is a registered trademark of Abbott Laboratories
  • Zonegran® is a registered trademark of Dainippon Pharmaceutical C. Ltd.
  • Gabatril® is a registered trademark of Cephalon
  • Keppra® is registered trademark of UCB Pharma
  • Zarontin® is a registered trademark of Pfizer
  • Lamictal® is a registered trademark of GlaxoSmithKline
  • Luminal® is a registered trademark of Abbott Laboratories
  • Dilantin® is a registered trademark of Pfizer
  • Lyrica is registered trademark of Pfizer
Medicaid patients with well-controlled epilepsy
Database records for patients with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
Prescription claim for at least one AED including lamotrigine, tiagabine, pregabalin, ethosuximide, lacosamide, phenytoin, carbamazepine, valproic acid, felbamate, levetiracetam, zonisamide, primidone, oxcarbazepine, vigabatrin, phenobarbital, gabapentin, topiramate.
Other Names:
  • Mysoline® is a registered trademark of Valeant Pharmaceuticals
  • Neurotin® is registered trademark of Pfizer
  • Inc
  • Vimpat® is a registered trademark of UCB Pharma
  • Tegretol® is a registered trademark of Novartis Pharmaceuticals
  • Trileptal® is a registered trademark of Novartis Pharmaceuticals
  • Sabril® is a registered trademark of Lundbeck Inc
  • Felbatol® is a registered trademark of MedPointe
  • Topamax® is a registered trademark of Ortho-McNeill-Janssen Pharmaceuticals
  • Depakote® is a registered trademark of Abbott Laboratories
  • Zonegran® is a registered trademark of Dainippon Pharmaceutical C. Ltd.
  • Gabatril® is a registered trademark of Cephalon
  • Keppra® is registered trademark of UCB Pharma
  • Zarontin® is a registered trademark of Pfizer
  • Lamictal® is a registered trademark of GlaxoSmithKline
  • Luminal® is a registered trademark of Abbott Laboratories
  • Dilantin® is a registered trademark of Pfizer
  • Lyrica is registered trademark of Pfizer
Medicaid patients with intermediate epilepsy
Database records for patients who are not classified as uncontrolled or well-controlled
Prescription claim for at least one AED including lamotrigine, tiagabine, pregabalin, ethosuximide, lacosamide, phenytoin, carbamazepine, valproic acid, felbamate, levetiracetam, zonisamide, primidone, oxcarbazepine, vigabatrin, phenobarbital, gabapentin, topiramate.
Other Names:
  • Mysoline® is a registered trademark of Valeant Pharmaceuticals
  • Neurotin® is registered trademark of Pfizer
  • Inc
  • Vimpat® is a registered trademark of UCB Pharma
  • Tegretol® is a registered trademark of Novartis Pharmaceuticals
  • Trileptal® is a registered trademark of Novartis Pharmaceuticals
  • Sabril® is a registered trademark of Lundbeck Inc
  • Felbatol® is a registered trademark of MedPointe
  • Topamax® is a registered trademark of Ortho-McNeill-Janssen Pharmaceuticals
  • Depakote® is a registered trademark of Abbott Laboratories
  • Zonegran® is a registered trademark of Dainippon Pharmaceutical C. Ltd.
  • Gabatril® is a registered trademark of Cephalon
  • Keppra® is registered trademark of UCB Pharma
  • Zarontin® is a registered trademark of Pfizer
  • Lamictal® is a registered trademark of GlaxoSmithKline
  • Luminal® is a registered trademark of Abbott Laboratories
  • Dilantin® is a registered trademark of Pfizer
  • Lyrica is registered trademark of Pfizer
Patients in a private health plan with uncontrolled epilepsy
Database records for patients with 2 or more consecutive changes in AED therapy occuring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within 365 days
Prescription claim for at least one AED including lamotrigine, tiagabine, pregabalin, ethosuximide, lacosamide, phenytoin, carbamazepine, valproic acid, felbamate, levetiracetam, zonisamide, primidone, oxcarbazepine, vigabatrin, phenobarbital, gabapentin, topiramate.
Other Names:
  • Mysoline® is a registered trademark of Valeant Pharmaceuticals
  • Neurotin® is registered trademark of Pfizer
  • Inc
  • Vimpat® is a registered trademark of UCB Pharma
  • Tegretol® is a registered trademark of Novartis Pharmaceuticals
  • Trileptal® is a registered trademark of Novartis Pharmaceuticals
  • Sabril® is a registered trademark of Lundbeck Inc
  • Felbatol® is a registered trademark of MedPointe
  • Topamax® is a registered trademark of Ortho-McNeill-Janssen Pharmaceuticals
  • Depakote® is a registered trademark of Abbott Laboratories
  • Zonegran® is a registered trademark of Dainippon Pharmaceutical C. Ltd.
  • Gabatril® is a registered trademark of Cephalon
  • Keppra® is registered trademark of UCB Pharma
  • Zarontin® is a registered trademark of Pfizer
  • Lamictal® is a registered trademark of GlaxoSmithKline
  • Luminal® is a registered trademark of Abbott Laboratories
  • Dilantin® is a registered trademark of Pfizer
  • Lyrica is registered trademark of Pfizer
Patients in a private health plan with well-controlled epileps
Database records for patients with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
Prescription claim for at least one AED including lamotrigine, tiagabine, pregabalin, ethosuximide, lacosamide, phenytoin, carbamazepine, valproic acid, felbamate, levetiracetam, zonisamide, primidone, oxcarbazepine, vigabatrin, phenobarbital, gabapentin, topiramate.
Other Names:
  • Mysoline® is a registered trademark of Valeant Pharmaceuticals
  • Neurotin® is registered trademark of Pfizer
  • Inc
  • Vimpat® is a registered trademark of UCB Pharma
  • Tegretol® is a registered trademark of Novartis Pharmaceuticals
  • Trileptal® is a registered trademark of Novartis Pharmaceuticals
  • Sabril® is a registered trademark of Lundbeck Inc
  • Felbatol® is a registered trademark of MedPointe
  • Topamax® is a registered trademark of Ortho-McNeill-Janssen Pharmaceuticals
  • Depakote® is a registered trademark of Abbott Laboratories
  • Zonegran® is a registered trademark of Dainippon Pharmaceutical C. Ltd.
  • Gabatril® is a registered trademark of Cephalon
  • Keppra® is registered trademark of UCB Pharma
  • Zarontin® is a registered trademark of Pfizer
  • Lamictal® is a registered trademark of GlaxoSmithKline
  • Luminal® is a registered trademark of Abbott Laboratories
  • Dilantin® is a registered trademark of Pfizer
  • Lyrica is registered trademark of Pfizer
Patients in a private health plan with intermediate epilepsy
Database records for patients who are not classified as uncontrolled or well-controlled
Prescription claim for at least one AED including lamotrigine, tiagabine, pregabalin, ethosuximide, lacosamide, phenytoin, carbamazepine, valproic acid, felbamate, levetiracetam, zonisamide, primidone, oxcarbazepine, vigabatrin, phenobarbital, gabapentin, topiramate.
Other Names:
  • Mysoline® is a registered trademark of Valeant Pharmaceuticals
  • Neurotin® is registered trademark of Pfizer
  • Inc
  • Vimpat® is a registered trademark of UCB Pharma
  • Tegretol® is a registered trademark of Novartis Pharmaceuticals
  • Trileptal® is a registered trademark of Novartis Pharmaceuticals
  • Sabril® is a registered trademark of Lundbeck Inc
  • Felbatol® is a registered trademark of MedPointe
  • Topamax® is a registered trademark of Ortho-McNeill-Janssen Pharmaceuticals
  • Depakote® is a registered trademark of Abbott Laboratories
  • Zonegran® is a registered trademark of Dainippon Pharmaceutical C. Ltd.
  • Gabatril® is a registered trademark of Cephalon
  • Keppra® is registered trademark of UCB Pharma
  • Zarontin® is a registered trademark of Pfizer
  • Lamictal® is a registered trademark of GlaxoSmithKline
  • Luminal® is a registered trademark of Abbott Laboratories
  • Dilantin® is a registered trademark of Pfizer
  • Lyrica is registered trademark of Pfizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Annualized Costs
Time Frame: 1 year
Average annualized overall healthcare costs and epilepsy-related healthcare costs were calculated for each treatment group. Epilepsy-related costs were those with a code for epilepsy. ED, Emergency Department; AMC, All Medical Costs; Ep Rel, Epilepsy Related. United States dollars were consumer price index adjusted for 2009.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

July 7, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Estimate)

October 8, 2012

Last Update Submitted That Met QC Criteria

October 4, 2012

Last Verified

June 1, 2012

More Information

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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