A multi-center, randomized, double-blind, placebo-controlled, parallel group, polysomnography study to investigate safety and efficacy of the rotigotine transdermal patch in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.

Trial Profile

A multi-center, randomized, double-blind, placebo-controlled, parallel group, polysomnography study to investigate safety and efficacy of the rotigotine transdermal patch in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Sep 2016

At a glance

  • Drugs Rotigotine (Primary)
  • Indications Restless legs syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors UCB
  • Most Recent Events

    • 25 Apr 2015 Primary endpoint has been met. (Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI)), according to an abstract presented at the 67th Annual Meeting of the American Academy of Neurology.
    • 25 Apr 2015 Results presented at the 67th Annual Meeting of the American Academy of Neurology.
    • 01 Oct 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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