Transdermal lisuride:

INTERVENTION: Trade Name: Dopergin Product Name: Lisuride TTS Product Code: NBt P 102 DZ Pharmaceutical Form: Transdermal patch INN or Proposed INN: Lisuride Current Sponsor code: Lisuride Other descriptive name: Lisuride TTS Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 2500‐ Pharmaceutical form of the placebo: Transdermal patch Route of administration of the placebo: Transdermal use CONDITION: Patients suffering from Restless Legs Syndrome (RLS) PRIMARY OUTCOME: Main Objective: The primary study objective is to investigate the efficacy of three different dosages of Lisuride TTS patches compared to placebo after 12 weeks of treatment in patients with idiopathic or uremic RLS. Changes in the IRLS total score are used as primary efficacy outcome measure. Primary end point(s): Changes between Baseline and Visit 6 (Week 12 / Day 85); in the total score of the IRLS total score will be analyzed; as a primary endpoint, and compared against the 4 different groups. Secondary Objective: The secondary study objectives are:; 1) to evaluate quality of life, tolerability and safety of Lisuride TTS patch treatment in comparison to placebo after 12 weeks of double‐blind treatment; 2) to assess long‐term efficacy, quality of life, tolerability, and safety of open‐labeled treatment with Lisuride TTS patches after 12 months, and to determine the effective dosage of Lisuride TTS in open‐labeled application. ; INCLUSION CRITERIA: ‐ Male and female patients, between 18 and 80 (inclusive) years of age. ‐ Diagnosis of idiopathic or uremic restless legs syndrome based on the four essential clinical features according to the International Restless Legs Study Group (IRLSSG). ‐ RLS Diagnostic Index (RLS‐DI) >= 10 ‐ Total score in the IRLS Rating Scale >= 15 at baseline ‐ RLS‐6 score “severity during the day at rest) >= 3 ‐ Patient has no previous treatment for RLS (de novo patients) or patient is not well controlled with current therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range