EpilepsyNCT01390909

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

An observational study of Epilepsy, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Epilepsy
What is being tested?: Anti-epileptic drug (AED)
How many people: 12,386 participants
Where: No sites listed yet
Study dates: May 2010to Jan 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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).

Who may be able to join

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

Who cannot join

Age less than 18 years

About this study

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).

Conditions: Epilepsy
Being tested: Anti-epileptic drug (AED)
Keywords: epilepsy, anti-epileptic drug, polytherapy, adherence, Medicaid
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anti-epileptic drug (AED)Drug
Also called Mysoline® is a registered trademark of Valeant Pharmaceuticals, Neurotin® is registered trademark of Pfizer, Inc, Vimpat® is a registered trademark of UCB Pharma
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.

Study groups in NCT01390909
Study group	Role	What they receive
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 Receives: Drug: Anti-epileptic drug (AED)
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 Receives: Drug: Anti-epileptic drug (AED)
Medicaid patients with intermediate epilepsy		Database records for patients who are not classified as uncontrolled or well-controlled Receives: Drug: Anti-epileptic drug (AED)
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 Receives: Drug: Anti-epileptic drug (AED)
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 Receives: Drug: Anti-epileptic drug (AED)
Patients in a private health plan with intermediate epilepsy		Database records for patients who are not classified as uncontrolled or well-controlled Receives: Drug: Anti-epileptic drug (AED)

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Annualized Costs
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.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Jan 2011

First posted11 Jul 2011 (estimated)
Study startMay 2010
Primary completionJan 2011
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EpilepsyStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 12,386 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01390909
Sponsor's protocol ID: 113917
Status last verified: Jun 2012
First submitted: 7 Jul 2011
Last updated: 8 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
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Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database
ClinicalTrials.gov ID: NCT01390909
Acronym / sponsor ID: 113917
Conditions: Epilepsy
Keywords: epilepsy, anti-epileptic drug, polytherapy, adherence, Medicaid
Study type: Observational
Recruitment status: Completed
Enrolment: 12,386 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 11 Jul 2011 (estimated)
Results: Posted 14 Feb 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 6

Arm	Type	Receives
Medicaid patients with uncontrolled epilepsy	–	Drug: Anti-epileptic drug (AED)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
Medicaid patients with well-controlled epilepsy	–	Drug: Anti-epileptic drug (AED)Database records for patients with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
Medicaid patients with intermediate epilepsy	–	Drug: Anti-epileptic drug (AED)Database records for patients who are not classified as uncontrolled or well-controlled
Patients in a private health plan with uncontrolled epilepsy	–	Drug: Anti-epileptic drug (AED)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
Patients in a private health plan with well-controlled epileps	–	Drug: Anti-epileptic drug (AED)Database records for patients with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
Patients in a private health plan with intermediate epilepsy	–	Drug: Anti-epileptic drug (AED)Database records for patients who are not classified as uncontrolled or well-controlled

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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).

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

Age less than 18 years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anti-epileptic drug (AED)Also: Mysoline® is a registered trademark of Valeant Pharmaceuticals, Neurotin® is registered trademark of Pfizer, Inc, Vimpat® is a registered trademark of UCB PharmaPrescription 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.	Drug	Medicaid patients with intermediate epilepsy, Medicaid patients with uncontrolled epilepsy, Medicaid patients with well-controlled epilepsy, Patients in a private health plan with intermediate epilepsy, Patients in a private health plan with uncontrolled epilepsy, Patients in a private health plan with well-controlled epileps

Primary outcome

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.

Results and safety

Results posted to the registry on 14 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medicaid, Well Controlled	3,454	3,454
Medicaid, Uncontrolled	3,552	3,552
Medicaid, Intermediate	3,552	3,552
Private, Well Controlled	602	602
Private, Uncontrolled	613	613
Private, Intermediate	613	613

Primary outcome: Average Annualized Costs

Time frame: 1 year. Mean (Standard Deviation). Unit: United States dollars

Measure	Medicaid, Uncontrolled, Subgroup n = 3454	Medicaid, Well Controlled n = 3454	Medicaid, Uncontrolled n = 3552	Medicaid, Intermediate n = 3552	Private, Uncontrolled, Subgroup n = 602	Private, Well Controlled n = 602	Private, Uncontrolled n = 613	Private, Intermediate n = 613
AEDs	1352 (4580)	462 (2072)	1357 (4590)	1050 (4297)	1697 (3979)	639 (2248)	1713 (3989)	1299 (3949)
Non-AEDs	5615 (15730)	3657 (11702)	5725 (16016)	4801 (15357)	4497 (11374)	3096 (10692)	4587 (11972)	3883 (9436)
Hospitalizations; AMC	6902 (31181)	958 (9518)	7041 (31499)	3513 (22265)	11308 (62399)	1697 (12292)	12357 (84898)	5858 (37310)
ED Visits; AMC	400 (1496)	97 (731)	421 (1661)	242 (1371)	586 (4392)	76 (804)	603 (4422)	254 (2898)
Outpatient Visits; AMC	2416 (11759)	1258 (9953)	2466 (11829)	1804 (11649)	5757 (24888)	3061 (13353)	5771 (24883)	5780 (37154)
Neurology Visits; AMC	86 (850)	21 (425)	86 (839)	52 (666)	556 (4306)	175 (1593)	566 (4352)	442 (4263)
Other Healthcare Services; AMC	22022 (106033)	23202 (103595)	22113 (107291)	23428 (119218)	1008 (5428)	436 (4444)	1026 (5472)	645 (3910)
Hospitalizations; Ep Rel	4102 (19775)	NA (NA)	4135 (19915)	1702 (13344)	6700 (48095)	NA (NA)	7646 (70525)	2413 (23487)

Medicaid, Uncontrolled, Subgroup vs Medicaid, Well Controlled: Median Difference (Final Values): 849 (95% CI 786 to 921), p <0.0001, Ordinary Least Squares Regression
Medicaid, Uncontrolled, Subgroup vs Medicaid, Well Controlled: Median Difference (Final Values): 1879 (95% CI 1636 to 2112), p <0.0001, Ordinary Least Squares Regression
Medicaid, Uncontrolled, Subgroup vs Medicaid, Well Controlled: Median Difference (Final Values): 5681 (95% CI 5257 to 6077), p <0.0001, Ordinary Least Squares Regression

Population analysed: For Arms 1 - 4, Medicaid-enrolled participants with uncontrolled epilepsy (see Arm Descriptions for Arm Title 1 and Arm Title 3) or matched participants with well-controlled or intermediate epilepsy. For Arms 5 - 8, privately-insured participants with uncontrolled epilepsy or matched participants with well-controlled or intermediate epilepsy.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Medicaid, Uncontrolled, Subgroup	0 of 0	0 of 0	Not reported
Medicaid, Well Controlled	0 of 0	0 of 0	Not reported
Medicaid, Uncontrolled	0 of 0	0 of 0	Not reported
Medicaid, Intermediate	0 of 0	0 of 0	Not reported
Private, Uncontrolled, Subgroup	0 of 0	0 of 0	Not reported
Private, Well Controlled	0 of 0	0 of 0	Not reported
Private, Uncontrolled	0 of 0	0 of 0	Not reported
Private, Intermediate	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Epilepsy

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Annualized Costs (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01390909.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2012.