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

PHASE3CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Restless Legs SyndromeEnd-Stage Renal Disease
Interventions
DRUG

Rotigotine

"Transdermal patch; Dose: 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.~Subjects start with a Rotigotine dose of 1 mg/24 h for 1 week. The dose can be increased weekly during Up-Titration Period until either the optimal or the maximal dose of 3 mg/24 h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1 mg/24 h every other day during Taper Period until complete withdrawal."

DRUG

Placebo

"Transdermal patch; Patches matching to active treatment patches in size and appearance.~Up to 3 weeks of Titration,~2 weeks of Maintenance,~Up to 4 days of Taper Period."

Trial Locations (15)

Unknown

606, Brandon

604, Newton

603, West Seneca

607, Dublin

605, West Chester

601, Austin

101, Innsbruck

201, Helsinki

203, Tampere

302, Bordeaux

301, Montpellier Cédex 5

404, Berlin

401, Marburg

402, Schwerin

502, Pisa

All Listed Sponsors
lead

UCB BIOSCIENCES GmbH

INDUSTRY

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 | Biotech Hunter | Biotech Hunter