NCT01455012

Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome

Multicenter, Double-Blind, Placebo-Controlled, Two-Arm, Randomized, Parallel, Treatment Intervention, Sleep Lab Phase 4 Study to Assess the Effect of Rotigotine on Nocturnal Blood Pressure in Patients With Idiopathic Restless Legs Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: UCB BIOSCIENCES GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Periodic Limb Movements (PLMs) during sleep in patients with Restless Legs Syndrome (RLS) have been shown to be associated with elevations in Blood Pressure (BP). Rotigotine has been shown to effectively reduce the incidence of PLMs in patients with RLS. The current study aims to demonstrate that treatment with Rotigotine could help reduce the number of nocturnal BP elevations associated with PLMs in patients with RLS.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Rotigotine	Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.
DRUG	Placebo	Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2011-10-19
• Last updated: 2013-07-26
• Results posted: 2013-07-18

Locations

6 sites across 1 country: Germany