Risk of Urinary Retention With Retigabine

NCT01462656 | Terminated

• 3 other identifiers: 115981WEUKSTV4551EPI40621
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Epilepsy

Keywords

anti-epileptic drug; ezogabine; AED polytherapy; epilepsy; AED monotherapy; retigabine; urinary retention

Outcome Measures

Primary Outcomes (1)

• The risk and time to onset of UR associated with post-marketing use of EZG AED polytherapy, and the incremental risk compared with non-EZG AED polytherapy use.

  From initiation of a new AED polytherapy regimen, until the earliest of an episode of UR, change in their AED regimen, end of follow-up, or end of study, whichever comes first, assesed up to three years.

Secondary Outcomes (3)

• The risk and time to onset of UR among patients using EZG vs. non-EZG AED polytherapy

  From initiation of a new AED polytherapy regimen, until the earliest of an episode of UR, change in their AED regimen, end of follow-up, or end of study, whichever comes first, assesed up to three years.

• The risk of UR associated with post-marketing use of EZG under circumstances not indicated in the product label

  From initiation of a new AED polytherapy regimen, until the earliest of an episode of UR, change in their AED regimen, end of follow-up, or end of study, whichever comes first, assesed up to three years.

• The risk of UR among non-EZG AED monotherapy patients and the differential risk in UR for monotherapy versus polytherapy-treated patients

  From initiation of a new AED monotherapy regimen, until the earliest of an episode of UR, change in their AED regimen, end of follow-up, or end of study, whichever comes first, assesed up to three years.

Study Arms (1)

Patients with urinary retention

Patients with urinary retention

Drug: Non-EZG containing AED polytherapy; Drug: EZG containing AED polytherapy; Drug: Non-EZG AED monotherapy; Drug: EZG AED monotherapy

Interventions

Non-EZG containing AED polytherapy DRUG

AED polytherapy without EZG

Patients with urinary retention

EZG containing AED polytherapy DRUG

AED polytherapy including EZG

Patients with urinary retention

Non-EZG AED monotherapy DRUG

AED monotherapy without EZG

Patients with urinary retention

EZG AED monotherapy DRUG

Any off-label use of EZG as monotherapy

Patients with urinary retention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study cohorts of interest will be identified from the HealthCore Integrated Research Database (HIRD). The HIRD contains fully adjudicated paid claims from the largest commercially insured population in the US, with dates of service for all non-capitated ambulatory, emergency department, inpatient, and outpatient encounters (including administrative claims for laboratory tests) for members with eligibility at the time of service.

You may qualify if:

• 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:
• Epilepsy and recurrent seizures
• Convulsions
• 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:

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Epilepsy; Urinary Retention

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: October 31, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 25, 2016

Record last verified: 2016-11