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).
- Idiopathic restless legs syndrome
- History of sleep disturbances