Rotigotine (Neupro®) Disease area studied Abbreviated title Phase Study ID Registry database Study results Plain language summary Publication (if available) Restless Legs Syndrome A Remote, Open-Label, Long-Term, Follow-up Study to Determine the Safety, Tolerability, and Efficacy of Rotigotine Transdermal System as Monotherapy in Adolescents with Restless Legs Syndrome Phase 3 RL0007 Terminated NCT039921962021-003403-18 LINK Parkinson's Disease Rotigotine versus ropinirole to assess the efficacy and safety of the rotigotine CDS patch in subjects with early-stage idiopathic Parkinson’s disease (Part 1) Phase 3 SP0513 Completed Eggert, A. and Bretzmann, C. Consult Pharm;2007;22;suppl. B;19, abs 40 38th Annual Meeting of the American Society of Consultant Pharmacists (ASCP), November 14-17, 2007;Philadelphia, United States Parkinson's Disease Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa Phase 3 SP0515 Completed NCT00244387 PDF PDF Poewe et al. Lancet Neurol;2007;6(6);513-520. Parkinson's Disease An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease Phase 3 SP0516 Completed NCT005019692004-000148-26 LINKLINK LeWitt et al. J Neural Transm;2013;120(7);1069-1081. Parkinson's Disease Trial to evaluate the efficacy and safety of rotigotine patch in subjects with advanced-stage, idiopathic Parkinson’s disease who are not well controlled on levodopa (Part 1). Phase 3 SP0650 Completed PDF PDF LeWitt et al. Neurology;2007;68;16;1262-1267 Parkinson's Disease An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease. (SP512OL) Phase 3 SP0702 Completed NCT00594165 LINK Elmer et al. Parkinsonism Relat Disord;2012;18(5);488-493. Restless Legs Syndrome Rotigotine Restless Legs Syndrome Dose Finding Trial Phase 2 SP0709 Completed NCT00243217 PDF Oertel et al. Sleep Med;2008;9(3);228-239. Restless Legs Syndrome Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS) Phase 2 SP0710 Completed NCT00498186 LINK Oertel et al. Lancet Neurol;2011;10(8);710-720. Parkinson's Disease An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease (SP715) Phase 3 SP0715 Completed NCT00594386 LINK LeWitt et al. J Neural Transm;2013;120(7);1069-1081. Parkinson's Disease An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease Phase 3 SP0716 Completed NCT00599196 LINK Giladi et al. J Neural Transm;2013;120(9);1321-1329. Restless Legs Syndrome Three Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome Phase 3 SP0790 Completed NCT001360452005-000428-18 LINK PDF PDF Trenkwalder et al. Lancet Neurol;2008;7(7);595-604. Restless Legs Syndrome Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects Phase 3 SP0791 Completed NCT004981082005-002611-25 LINK PDF Benes et al. Mov Disord;2010;25;suppl. 2;S515. 14th International Congress of Parkinson's Disease and Movement Disorders (MDS), June 13-17, 2010;Buenos Aires, Argentina. Restless Legs Syndrome Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome Phase 3 SP0792 Completed NCT00135993 PDF PDF Hening et al. Mov Disord;2010;25(11);1675-1683. Restless Legs Syndrome An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome Phase 3 SP0793 Completed NCT00263068 PDF Allen et al. Sleep;2010;33;suppl.;A251. 24th Annual Meeting of the Associated Professional Sleep Societies (APSS), June 5-9, 2010;San Antonio, USA. Restless Legs Syndrome A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome Phase 3 SP0794 Completed NCT002752362005-002814-39 LINK PDF Oertel et al. Sleep Med;2010;11(9);848-856. Parkinson's Disease A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease Phase 3 SP0824 Completed NCT002420082004-002650-59 LINK PDF LeWitt et al. Clin Neuropharmacol;2007;30(5);256-265. Parkinson's Disease A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease Phase 3 SP0825 Completed NCT002439712004-002609-66 LINK PDF Trenkwalder et al. Sleep;2007;30;Suppl. S;A283-A284. 21st Annual Meeting of the Associated Professional Sleep Societies (APSS), June 9-14, 2007;Minneapolis, USA. Parkinson's Disease A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's Disease Phase 3 SP0826 Completed NCT002439452004-002598-21 LINK PDF Giladi et al. J Neural Transm;2010;117(12);1395-1399. Parkinson's Disease An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease Phase 3 SP0833 Completed NCT005056872004-002641-12 LINKLINK Parkinson's Disease Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms Phase 2 SP0873 Completed NCT002961922005-004290-19 LINKLINK Restless Legs Syndrome Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms Phase 2 SP0879 Completed NCT003898312006-001937-17 LINKLINK Parkinson's Disease A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery Phase 4 SP0882 Completed NCT005944642006-005438-19 LINKLINK Wüllner et al. J Neural Transm;2010;117(7);855-859. Fibromyalgia The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults. (SP888) Phase 2 SP0888 Completed NCT00464737 LINK Parkinson's Disease Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine (RECOVER) Phase 3 SP0889 Completed NCT004740582006-006752-35 LINKLINK Trenkwalder et al. Mov Disord;2011;26(1);90-99. Parkinson's Disease Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine Phase 3 SP0908 Completed NCT00593606 LINK PDF Kim et al. BMC Neurol;2011;11;100. Parkinson's Disease Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients Phase 3 SP0914 Completed NCT01646268 LINK PDF Zhang et al. Parkinsonism Relat Disord 2016, 28, 49-55 Parkinson's Disease Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease Phase 3 SP0915 Terminated NCT005195322006-006907-35 LINKLINK Trenkwalder et al. Basal ganglia;2012;2(2);79-85. Parkinson's Disease Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease (REFRESH-PD) Phase 4 SP0919 Terminated NCT015198822011-000056-42 Parkinson's Disease Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch Phase 3 SP0921 Completed NCT00522379 LINK Nicholas et al. J Parkinsons Dis;2014; 4(3):361-373 Restless Legs Syndrome A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis Phase 3 SP0934 Completed NCT015370422011-003486-15 Dauvilliers et al. Am J Kidney Dis;2016;68/3, 434-443 Parkinson's Disease Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms Phase 4 SP0976 Completed NCT013008192010-021394-37 Antonini et aL. Eur J Neurol;2015;22;10;1400-1407 Restless Legs Syndrome Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome (ENCORE) Phase 4 SP0977 Completed NCT014550122011-000053-23 Cassel et al. Sleep Med;2016, 17, 109-120 Bauer et al. Neurology;2016;86(19):1785-1793 Restless Legs Syndrome Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome Phase 2 SP1004 Completed NCT014957932014-004383-37 Elshoff et al. Sleep Medicine;2017, 32:48-55 Restless Legs Syndrome Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome Phase 2 SP1005 Completed NCT014981202016-000635-40 Restless Legs Syndrome A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause Phase 3 SP1006 Terminated NCT037289332018-001445-13 LINKLINK Parkinson's Disease Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients Phase 3 SP1037 Completed NCT01646255 LINK PDF Zhang et al. Parkinsonism Relat Disord 2017, 44, 6-12 Parkinson's Disease Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients Phase 4 SP1041 Completed NCT01523301 LINK Chung et al., Expert Opin Pharmacother;2016;17(11):1453-1461 Parkinson's Disease Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction (ROADMAP) Phase 3 SP1055 Terminated NCT01536015 LINK Parkinson's Disease Rotigotine in Adults for the Treatment of Early Parkinson’s Disease Phase 2 SP506 Completed PDF Parkinson's Disease Rotigotine in Adults for the Treatment of Early Parkinson’s Disease Phase 3 SP512 Completed PDF Parkinson's Disease Rotigotine in Adults for the Treatment of Early Parkinson’s Disease Phase 3 SP513 Completed PDF
