Status:
TERMINATED
Risk of Urinary Retention With Retigabine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Epilepsy
Eligibility:
All Genders
Brief Summary
A prospective cohort study of antiepileptic drug (AED) polytherapy-treated epilepsy patients within the HealthCore Integrated Research Database (HIRD) will be conducted. Following the launch of Ezogab...
Detailed Description
Epilepsy is one of the most common neurological disorders, with a prevalence of active disease between 0.3 and 1.8% based on population-based studies across the world (0.7% in US) using medical record...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Prospective Cohort (indicated use)
- Patients with at least one medical claim carrying an ICD-9 code for epilepsy. The following ICD-9 codes will be used to identify patients with epilepsy:
- 345 Epilepsy and recurrent seizures
- 3 Convulsions
- 39 Other convulsions
- Patients initiating a new AED monotherapy\* or polytherapy\*\* following the launch of EZG.
- At least 6 months of continuous healthcare plan enrolment before initiation of the new AED (monotherapy or polytherapy) following the launch of EZG. This will allow an assessment of baseline co-morbidities and concomitant medication use.
- Aged ≥18 years at initiation of the new AED (monotherapy or polytherapy).
- Prospective Cohort (non-indicated use)
- Epilepsy patients initiating EZG AED monotherapy
- Patients \<18 years old initiating EZG for epilepsy
- Patients initiating EZG for any reason other than epilepsy
- Patients initiating EZG AED polytherapy with less than six months of continuous healthcare enrolment who were excluded from the cohort described under the primary objective
- Retrospective Cohort
- Patients with at least one medical claim carrying an ICD-9 code for epilepsy in the three year period preceding the launch of EZG. The following ICD-9 codes will be used to identify patients with epilepsy:
- 345 Epilepsy and recurrent seizures
- 3 Convulsions
- 39 Other convulsions
- Patients initiating a new AED monotherapy\* or polytherapy\*\* regimen in the three year period preceding the launch of EZG.
- At least 6 months of continuous healthcare plan enrolment before initiation of the new AED regimen (monotherapy or polytherapy) during the three year period preceding the launch of EZG. This will allow an assessment of baseline co-morbidities and concomitant medication use.
- Aged ≥18 years at initiation of the new AED (monotherapy or polytherapy).
- This will include patients substituting an AED monotherapy. \*\*This will include patients switching from a monotherapy to polytherapy regimen and those substituting an AED within an existing polytherapy regimen.
Exclusion
Key Trial Info
Start Date :
February 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01462656
Start Date
February 1 2011
End Date
August 1 2016
Last Update
November 25 2016
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.