Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: Rotigotine
Intervention description: 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)
Intervention MeSH terms: Rotigotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Rotigotine; Neupro®

Summary:

      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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed the preceding trial SP709 (NCT00243217)

        Exclusion Criteria:

          -  Subject did suffer from a serious adverse event during trial SP709 (NCT00243217) which
             is ongoing at the end of that trial and is assessed to be related to the study
             medication by the investigator and/or the Sponsor

          -  Sleep disturbances

          -  Further clinically relevant concomitant diseases such as polyneuropathy, akathisia,
             claudication, varicosis, muscle fasciculation, painful legs and moving toes, or
             radiculopathy

          -  Other central nervous diseases

          -  One psychotic episode since start of study SP709

          -  Any medical or psychiatric condition, which in the opinion of the investigator can
             jeopardize or would compromise the subject's ability to participate in this trial

          -  Clinically relevant cardiac dysfunction and arrhythmias

          -  The subject has at entry in study SP710, a QTc interval ≥ 500 msec and/or a QTc
             interval which has increased by ≥ 60 msec as compared to the average baseline (Visit
             2) QTc interval of study SP709

          -  Subject has clinically relevant renal dysfunction (serum creatine ≥ 2.0 mg/dl)

          -  Subject has clinically relevant hepatic dysfunction (total bilirubin > 2.0 mg/dl or
             ALT and/or AST greater than two times the upper limit of the reference range

          -  Subject has a newly diagnosed or relapsing neoplastic disease since the start of study
             SP709

          -  Subject has a known hypersensitivity to any components of the trial medication or
             comparative drugs as stated in this protocol

          -  Subject needs drugs prohibited in the course of this trial: neuroleptics, bupidine,
             hypnotics, antidepressants, anxiolytic drugs, anticonvulsive therapy,
             psychostimulatory drugs, other L-Dopa or dopamine agonist therapy, opioids,
             benzodiazepines, MAO inhibitors, sedative antihistamines, amphetamines

          -  Subject is abusing alcohol or drug since start of SP709

          -  Subject is pregnant or nursing or woman of child-bearing potential who is not
             surgically sterile, two years postmenopausal, or does not practice two combined
             methods of contraception, unless sexually abstinent

          -  Subject pursues shift work or is subject to other continuous non-disease-related life
             conditions which do not allow regular sleep at night

          -  Subject has clinically relevant vasculopathies (eg, varix or arteriosclerosis)

          -  Subject has significant skin hypersensitivity to adhesive or other transdermals or
             recent unresolved contact dermatitis

          -  Subject has symptomatic orthostatic hypotension, or a systolic blood pressure (SBP)
             less tham 105mmHg and/or a drop in SBP of > 20mmHg or a drop of > 10mmHg in diastolic
             BP (DBP) on standing at baseline visit (Visit 1)