This is a multi-center, open-label extension trial conducted at the same European sites that participated in trial SP 709 (NCT00243217). The trial is designed to collect long-term safety and tolerability, efficacy correlates, and quality of life data in subjects with idiopathic Restless Leg Syndrome (RLS). The duration of treatment is approximately 5 years. Subject will be up-titrated to their optimal dose (administration of 1 patch per day, 5 different doses and patch sizes).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
295
Rotigotine transdermal patches once daily: 2.5cm2 (0.5mg/24 hours) 5cm2 (1mg/24 hours) 10cm2 (2mg/24 hours) 15cm2 (3mg/24 hours) 20cm2 (4mg/24 hours)
Unnamed facility
Innsbruck, Austria
Unnamed facility
Bamberg, Germany
Unnamed facility
Berlin, Germany
Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time frame: Up to five years
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time frame: Up to five years
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Unnamed facility
Bielefeld, Germany
Unnamed facility
Gelsenkirchen, Germany
Unnamed facility
Gera, Germany
Unnamed facility
Halle, Germany
Unnamed facility
Jena, Germany
Unnamed facility
Kassel, Germany
Unnamed facility
Köthen, Germany
...and 14 more locations