Clinical Trial: Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Five-Arm Parallel-Group Trial to Investigate the Efficacy and Safety of Four Different Transdermal Doses of Rotigotine in Subjects With Id

Brief Summary:

Subjects who meet the diagnosis of idiopathic restless legs syndrome (RLS) based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group (IRLSSG) are allowed to enroll in this trial.

The primary objective of this trial is to demonstrate that rotigotine (SPM 936) is efficacious in subjects with idiopathic restless legs syndrome. Additional objectives are to investigate the safety and tolerability of rotigotine.

Subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. Approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. The maximum duration of the trial is approximately 8 months (consisting of a 4-week Titration Period, a 6-month Maintenance Period, a 7-day Taper Period, and a 30-day Safety Follow-Up Period).


Detailed Summary:
Sponsor: UCB Pharma

Current Primary Outcome: IRLS sum score and CGI Item 1 score severity of illness [ Time Frame: From Baseline at the end of the Maintenance Period ]

Original Primary Outcome:

Current Secondary Outcome:

  • IRLS Responder: A responder is a subject with a decrease of ≥50% in IRLS sum score [ Time Frame: From Baseline at the end of the Maintenance Period ]
  • CGI Item 1 Responder: A responder is defined as a subject with a decrease of ≥50% in CGI Item 1 [ Time Frame: From Baseline at the end of the Maintenance Period ]
  • Changes in CGI Items 2-3 (continuous) during the Maintenance Period; Change from Baseline in RLS-6 Rating Scales at the end of the Maintenance Period


Original Secondary Outcome:

Information By: UCB Pharma

Dates:
Date Received: August 24, 2005
Date Started: May 2005
Date Completion:
Last Updated: September 24, 2014
Last Verified: September 2009