A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Trial Comparing Fixed Doses of 0.25 mg, 0.50 mg and 0.75 mg Pramipexole (Mirapex®) Administered Orally to Investigate the Safety and Efficacy in Patients With Idiopathic Restless Legs Syndrome for 12 Weeks

简要总结

主要结局

次要结局

• CGI-I responder analysis(at week 4, 6 and 12)
• Change from baseline in CGI-Severity(at week 4, 6 and 12)
• CGI-therapeutic effect(at week 4, 6 and 12)
• CGI-Side effects(at week 4, 6 and 12)
• Patient Global Impression (PGI)(at week 1-4, 6 and 12)
• Change in routine laboratory tests(week 12)
• RLSRS response (≥50% reduction from baseline in RLSRS)(at week 4, 6 and 12)
• Change in Physical examinations including eye examinations with ophthalmoscopic retinal eye examinations and a full skin dermatologic examination(week 12)
• Visual analogue scales to assess RLS severity before sleep onset, during night and during day, and satisfaction with sleep(at week 4, 6 and 12)
• Change from baseline in Epworth sleepiness scale (ESS)(at week 4, 6 and 12)
• Change from baseline in RLS-QOL (Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire)(at week 6 and 12)
• Change from baseline in Augmentation Severity Rating Scale of IRLSSG(at week 6 and 12)
• Change in systolic and diastolic blood pressure (after 5 minutes supine and subsequently after 1 minute standing)(week 12)
• Change in pulse rate (palpation after 5 minute supine and subsequent after 1 minute standing)(week 12)
• Assessment of sudden onset of sleep (SOOS)(up to 93 days)
• Change in Electrocardiogram(12 weeks)
• Incidence of Adverse evens (including withdrawal symptoms and rebound symptoms)(up to 93 days)
• Concomitant medication reporting(12 weeks)
• Early withdrawal phenomena(12 weeks)