Risk of Urinary Retention With Retigabine (NCT01462656) | Clinical Trial Compass
TerminatedNot Applicable
Risk of Urinary Retention With Retigabine
Stopped: This study was halted as the preliminary analysis revealed that the numbers were too low to warrant continuing the project
1 participantsStarted 2011-02
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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\*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: 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.