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.
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
- 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.