Clinical Trial: An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-Label Extension Trial to Investigate the Safety and Tolerability of Long-Term Treatment With Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
Brief Summary:
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year. Subjects who successfully completed the Maintenance Period and the Taper Period of SP792 are allowed to enroll in this trial.
All subjects will begin the Titration Period at a daily dosage of 1.125mg rotigotine (2.5cm2 patch). Subjects will be up-titrated at 7-day intervals in 1.125mg (2.5cm2 increments, initial titration step only) and 2.25mg intervals (5cm2) increments to a maximum dose of 6.75mg/day (15cm2) rotigotine. The maximum length of titration is 28 days (±3 days), although not all subjects will require 28 days to reach their optimal dose.
A subject's dose may be increased or decreased, as needed by the investigator to maintain a subject's effective dose during the Maintenance Period. A Taper Period is provided to allow for safe, gradual withdrawal from trial medication
Detailed Summary:
Sponsor: UCB Pharma
Current Primary Outcome: Safety and tolerability will be assessed by adverse events, changes in laboratory tests, changes in vital signs, physical and neurological examination, changes in menstrual and sexual function, global subject rating [ Time Frame: 1 year ]
Original Primary Outcome:
Current Secondary Outcome: To obtain data on changes in severity in RLS symptoms and quality of life over a one year maintenance period. [ Time Frame: 1 year ]
Original Secondary Outcome:
Information By: UCB Pharma
Dates:
Date Received: December 5, 2005
Date Started: December 2005
Date Completion:
Last Updated: September 24, 2014
Last Verified: September 2009
