Risk of Urinary Retention With Retigabine

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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 Ezogabine (EZG), patients initiating a new AED polytherapy regimen will be followed until the earliest of an episode of urinary retention (UR), change in their AED regimen, end of follow-up, or end of study (when the specified sample size of EZG AED polytherapy users has been attained). After the end of study, the incidence of UR during exposures to EZG and non-EZG AED polytherapies will be compared. Polytherapy will be defined as treatment regimen containing at least two different AEDs.

A prospective cohort study of patients who receive EZG under circumstances not indicated in the product label within the HIRD will also be conducted. Following the launch of EZG, epilepsy patients initiating AED monotherapy with EZG as well as non-epilepsy patients initiating EZG for another disease will be followed until the earliest of an episode of UR, change in their AED regimen (if applicable), end of follow-up, or end of study. The incidence of UR during exposure to EZG under circumstances not indicated in the product label will be described. A descriptive analysis of the patients will also be included.

To meet the other secondary objective, non-EZG AED monotherapy users will be identified in the prospective cohort and incidence of UR will be calculated to determine if there is a difference in UR risk between monotherapy and polytherapy AED use.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Ezogabine

Criteria

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

• 780.3 Convulsions

• 780.39 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

• 780.3 Convulsions

• 780.39 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.