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Rotigotine (Neupro®)

Disease area studied Abbreviated title Phase Study ID Registry database Study results Plain language summary Publication (if available)
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) 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
NCT00501969
2004-000148-26
LINK
LINK
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
NCT00136045
2005-000428-18
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
NCT00498108
2005-002611-25
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
NCT00275236
2005-002814-39
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
NCT00242008
2004-002650-59
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
NCT00243971
2004-002609-66
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
NCT00243945
2004-002598-21
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
NCT00505687
2004-002641-12
LINK
LINK
Parkinson's Disease Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms Phase 2 SP0873
Completed
NCT00296192
2005-004290-19
LINK
LINK
Restless Legs Syndrome Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms Phase 2 SP0879
Completed
NCT00389831
2006-001937-17
LINK
LINK
Parkinson's Disease A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery Phase 4 SP0882
Completed
NCT00594464
2006-005438-19
LINK
LINK
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
NCT00474058
2006-006752-35
LINK
LINK
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
NCT00519532
2006-006907-35
LINK
LINK
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
NCT01519882
2011-000056-42
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
NCT01537042
2011-003486-15
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
NCT01300819
2010-021394-37
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
NCT01455012
2011-000053-23
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
NCT01495793
2014-004383-37
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
NCT01498120
2016-000635-40
Restless Legs Syndrome A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause Phase 3 SP1006
Ongoing
NCT03728933
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
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
Ongoing
NCT03992196