REMS Retigabine Study

Epilepsy Clinical Trial

Official title: REMS Prescriber and Pharmacist Understanding of the Risk of Urinary Retention With POTIGA™

Status Completed

Clinical Trial Summary

As part of a post-marketing commitment, GSK will conduct a survey of prescribers' and pharmacists' understanding of the risk of urinary retention with retigabine products. This is to address the effectiveness of the Risk Evaluation and Mitigation Strategy (REMS) as outlined in the REMS approved by the FDA on 10th June 2011. The objectives of this survey are to assess prescribers' and pharmacists' understanding of the risk of urinary retention and the symptoms of acute urinary retention potentially associated with retigabine use as evaluated by a survey instrument.

This is a cross-sectional study of approximately 200 physicians (e.g. neurologists/epileptologists/neurosurgeons) who have prescribed retigabine at least once in the last 12 months, and 200 pharmacists who have dispensed an anti-epileptic drug (AED) at least once in the last 3 months. The primary outcome of the survey is the proportion of physicians and pharmacists providing correct responses to a series of questions concerning the risk of urinary retention and the symptoms of acute urinary retention that may be associated with retigabine. The risks captured will be those described in the retigabine Dear Healthcare Provider (DHCP) letters, specifically risks of urinary retention.

Clinical Trial Description

POTIGA is a trademark of Valeant Pharmaceuticals North America, used by GlaxoSmithKline under license. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

• NCT number: NCT01938560
• Study type: Observational
• Source: GlaxoSmithKline
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Completion date: May 2013