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

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ClinicalTrials.gov Identifier: NCT01390909
Recruitment Status : Completed
First Posted : July 11, 2011
Results First Posted : February 14, 2012
Last Update Posted : October 8, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Epilepsy
Intervention: Drug: Anti-epileptic drug (AED)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Medicaid, Well Controlled Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
Medicaid, Uncontrolled Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort.
Medicaid, Intermediate Database records for participants who are not classified as uncontrolled or well controlled
Private, Well Controlled Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
Private, Uncontrolled Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort.
Private, Intermediate Database records for participants who are not classified as uncontrolled or well controlled

Participant Flow:   Overall Study
    Medicaid, Well Controlled   Medicaid, Uncontrolled   Medicaid, Intermediate   Private, Well Controlled   Private, Uncontrolled   Private, Intermediate
STARTED   3454   3552   3552   602   613   613 
Participants in Subgroup   0   3454   0   0   602   0 
COMPLETED   3454   3552   3552   602   613   613 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Medicaid, Well Controlled Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
Medicaid, Uncontrolled Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (3454 participants) were matched with participant records in the Medicaid, well-controlled cohort.
Medicaid, Intermediate Database records for participants who are not classified as uncontrolled or well controlled
Private, Well Controlled Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
Private, Uncontrolled Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (602 participants) were matched with participant records in the Medicaid, well-controlled cohort.
Private, Intermediate Database records for participants who are not classified as uncontrolled or well controlled
Total Total of all reporting groups

Baseline Measures
   Medicaid, Well Controlled   Medicaid, Uncontrolled   Medicaid, Intermediate   Private, Well Controlled   Private, Uncontrolled   Private, Intermediate   Total 
Overall Participants Analyzed 
[Units: Participants]
 3454   3552   3552   602   613   613   12386 
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
             
Overall Study   41.5  (15.4)   41.3  (14.1)   41.2  (14.6)   54.2  (17.1)   54.1  (17.3)   54.6  (16.7)   43.2  (6.5) 
Subgroup   NA [2]   41.4  (14.2)   NA [2]   NA [2]   54.0  (17.4)   NA [2]   43.3  (6.3) 
[1] For the total population and the subgroup total population, a weighted average of the individual study group means and number of participants was used. The standard deviation (SD) is the SD of the study group means.
[2] There are no subgroup participants.
Gender, Customized [1] 
[Units: Participants]
             
Female, Overall Study   2106   2171   2159   341   351   332   7460 
Male, Overall Study   1348   1381   1393   261   262   281   4926 
Female, Subgroup   NA [1]   2091   NA [1]   NA [1]   345   NA [1]   2436 
Male, Subgroup   NA [1]   345   NA [1]   NA [1]   257   NA [1]   602 
[1] There are no subgroup participants.
Number of Days of Observation [1] [2] 
[Units: Days of observation]
Mean (Standard Deviation)
             
Overall Study   2184  (1181)   2296  (1132)   2502  (1124)   1572  (847)   1478  (749)   1739  (792)   2221  (385) 
Subgroup   NA [2]   2290  (1133)   NA [2]   NA [2]   1485  (751)   NA [2]   2170.5  (402.5) 
[1] For the total population and subgroups, a weighted average of the individual study group means and number of participants was used. The SDs reflect the SDs of the study group means.
[2] There are no subgroup participants.
Charlson Comorbidity Index (CCI) Scores [1] [2] 
[Units: Scores on a scale]
Mean (Standard Deviation)
             
Overall Study   0.98  (1.83)   1.09  (1.84)   1.00  (1.78)   1.13  (1.65)   1.32  (1.91)   1.20  (1.82)   1.05  (0.11) 
Subgroup   NA [2]   1.08  (1.83)   NA [2]   NA [2]   1.29  (1.88)   NA [2]   1.11  (1.66) 
[1] The Charlson Comorbidity Index estimates 10-year mortality risk. Scores range from 0 - 37, with a lower score indicating a higher chance of survival. For the total population and the subgroup, a weighted average of the study group means was used. The standard deviation (SD) is the SD of the study group means.
[2] There are no subgroup participants.
Number of participant records with diagnosis codes for the indicated diseases or disorders [1] 
[Units: Participant records]
             
Alzheimer’s Disease, Overall Study   94   93   84   12   20   19   322 
Alzheimer's Disease Subgroup   NA [1]   93   NA [1]   NA [1]   20   NA [1]   113 
Brain Tumor, Overall Study   53   63   40   38   50   43   287 
Brain Tumor, Subgroup   NA [1]   62   NA [1]   NA [1]   44   NA [1]   106 
Meningitis, Overall Study   12   16   13   11   10   6   68 
Meningitis, Subgroup   NA [1]   15   NA [1]   NA [1]   9   NA [1]   24 
Migraine, Overall Study   198   262   262   41   42   35   840 
Migraine, Subgroup   NA [1]   239   NA [1]   NA [1]   41   NA [1]   280 
Stroke, Overall Study   267   303   264   123   134   154   1245 
Stroke, Subgroup   NA [1]   302   NA [1]   NA [1]   128   NA [1]   430 
Anxiety Disorders, Overall Study   356   447   440   32   41   28   1344 
Anxiety Disorders, Subgroup   NA [1]   410   NA [1]   NA [1]   38   NA [1]   448 
Bipolar Disorder, Overall Study   428   439   472   22   18   15   1394 
Bipolar Disorder, Subgroup   NA [1]   397   NA [1]   NA [1]   17   NA [1]   414 
Depression, Overall Study   821   890   897   90   95   102   2895 
Depression, Subgroup   NA [1]   833   NA [1]   NA [1]   90   NA [1]   923 
Psychosis, Overall Study   809   794   816   62   65   65   2611 
Psychosis, Subgroup   NA [1]   754   NA [1]   NA [1]   65   NA [1]   819 
Personality Disorder, Overall Study   951   1062   1024   51   68   58   3214 
Personality Disorder, Subgroup   NA [1]   1001   NA [1]   NA [1]   67   NA [1]   1068 
Mental Retardation, Overall Study   482   322   434   5   11   8   1262 
Mental Retardation, Subgroup   NA [1]   312   NA [1]   NA [1]   11   NA [1]   323 
[1] There are no subgroup participants.


  Outcome Measures

1.  Primary:   Average Annualized Costs   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01390909     History of Changes
Other Study ID Numbers: 113917
First Submitted: July 7, 2011
First Posted: July 11, 2011
Results First Submitted: October 13, 2011
Results First Posted: February 14, 2012
Last Update Posted: October 8, 2012