Transdermal Lisuride:

INTERVENTION: Product Name: Lisuride Pharmaceutical Form: Transdermal patch INN or Proposed INN: Lisuride CAS Number: 18016‐80‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2,5‐ Pharmaceutical form of the placebo: Transdermal patch Route of administration of the placebo: Transdermal use Product Name: Lisuride Pharmaceutical Form: Transdermal patch INN or Proposed INN: Lisuride CAS Number: 18016‐80‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Transdermal patch Route of administration of the placebo: Transdermal use Trade Name: Requip Product Name: Ropinirol Pharmaceutical Form: Capsule* INN or Proposed INN: Ropinirol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0,25‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Requip Product Name: Ropinirol Pharmaceutical Form: Capsule* INN or Proposed INN: Ropinirol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0,5‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Requip Product Name: Ropinirol Pharmaceutical Form: Capsule* INN or Proposed INN: Ropinirol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1,0‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Requip Product Name: Ropinirol Pharmaceutical Form: Capsule* INN or Proposed INN: Ropinirol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2,0‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: Idiopathic and Uremic Restless Legs Syndrome (RLS) ; MedDRA version: 7.0 Level: LLT Classification code 10058920 PRIMARY OUTCOME: Main Objective: (1) The first primary study objective is to investigate the superior efficacy of an optimized individual dose of transdermal Lisuride (dose range: 2.5 to 7.5 mg every second day, patch sizes: 10 cm2 to 30cm2) with placebo after 12 weeks. ; (2) The second primary study objective is to investigate the superior efficacy of an optimized individual dose of transdermal Lisuride (dose range: 2.5 to 7.5 mg every second day, patch sizes: 10 cm2 to 30cm2) with an individu‐ally optimized dose of oral Ropinirole (dose range: 1.0 mg to 3.0 mg / day) after 12 weeks. ; (3) The third primary study objective is to investigate the superior efficacy of an optimized individual dose of Ropinirole (dose range: 1.0 to 3.0 mg / day) compared to placebo after 12 weeks.; Changes in the IRLS total score are used as primary efficacy outcome measure. ; Primary end point(s): Primary efficacy variable:; International RLS Study Group Rating Scale (IRLS): ; Absolute change in the IRLS sum score from baseline (Visit 2) to Visit 7.; Hierarchy of comparisons:; 1) Lisuride versus Placebo ; 2) Lisuride versus Ropinirole; 3) Ropinirole versus Placebo ; Secondary Objective: The secondary study objectives are:; (1) to evaluate further efficacy criteria, quality of life, tolerability and safety of Lisuride TTS patch treatment in comparison to placebo and Ropinirole af‐ter 12 weeks of double‐blind treatment;; (2) to evaluate further efficacy criteria, quality of life, tolerability and safety of Ropinirole in comparison to placebo after 12 weeks of double‐blind treat‐ment;; (3) to evaluate long‐term efficacy, quality of life, tolerability and safety of Lisuride TTS patch treatment after open‐label treatment between week 13 and week 48. ; INCLUSION CRITERIA: 1. Informed consent: Patient is informed and given ample time and opportunity to think about participation in the study and has given written informed consent. 2. Presence of RLS: Idiopathic or uremic restless legs syndrome. Uremic patients must un‐dergo at least two, usually three hemodialyses per week. Patients with peritoneal dialysis are not to be enrolled. 3. Previous treatment: ‐ Previously untreated for RLS (de novo patients) or ‐ Patients dissatisfied with any preceding therapy, who had responded at least initially to previous dopaminergic therapy, and ‐ for whom a dopaminergic therapy with Lisuride or Ropinirole is indicated. 4. Gender: Males and females. 5. Age: Males and females aged between 18 and 80 years (boundaries included). 6. BMI: Body Mass Index (BMI) = 18.0 and ? 35.0 (body mass in kg divided by (body height in meter) 2). 7. Patient’s capability: Patient is capable ‐ of accurately filling out evaluation forms