Risk of Urinary Retention With Retigabine - Full Text View

Purpose

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.

Condition	Intervention
Epilepsy	Drug: Non-EZG containing AED polytherapy Drug: EZG containing AED polytherapy Drug: Non-EZG AED monotherapy Drug: EZG AED monotherapy


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Post Marketing Surveillance Study to Monitor the Risk of Urinary Retention in Retigabine Users

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Ezogabine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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. [ Time Frame: 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 Outcome Measures:

The risk and time to onset of UR among patients using EZG vs. non-EZG AED polytherapy [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. ]


Estimated Enrollment:	1
Study Start Date:	February 2011
Study Completion Date:	August 2016
Primary Completion Date:	August 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients with urinary retention Patients with urinary retention	Drug: Non-EZG containing AED polytherapy AED polytherapy without EZG Drug: EZG containing AED polytherapy AED polytherapy including EZG Drug: Non-EZG AED monotherapy AED monotherapy without EZG Drug: EZG AED monotherapy Any off-label use of EZG as monotherapy

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Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462656

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01462656 History of Changes
Other Study ID Numbers:	115981 WEUKSTV4551 ( Other Identifier: GSK ) EPI40621 ( Other Identifier: GSK )
Study First Received:	July 21, 2011
Last Updated:	November 23, 2016

Keywords provided by GlaxoSmithKline:


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

Additional relevant MeSH terms:


Epilepsy Urinary Retention Brain Diseases Central Nervous System Diseases Nervous System Diseases Urination Disorders	Urologic Diseases Ezogabine Anticonvulsants Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017