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

PHASE4CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

May 31, 2012

Study Completion Date

June 30, 2012

Conditions
Restless Legs Syndrome
Interventions
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.

Trial Locations (6)

Unknown

Berlin

Kassel

Marburg

München

Münster

Schwerin

All Listed Sponsors
lead

UCB BIOSCIENCES GmbH

INDUSTRY

NCT01455012 - Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome | Biotech Hunter | Biotech Hunter