drugset
drugset / Trial / NCT01537042

A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis

NCT01537042 ↗

Phase 3 Completed 30 enrolled UCB BIOSCIENCES, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis. The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to investigate the effect of Rotigotine on quality of life and sleep.

Timeline

Start
2012-04
Primary completion
2013-10
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Rotigotine Unknown 1 mg Other
Subject Rotigotine Unknown 2 mg Other
Subject Rotigotine Unknown 3 mg Other

Indications

end stage renal failure restless legs syndrome