Rotigotine (Neupro®)
| Disease area studied | Abbreviated title | Phase | Study ID | Registry database | Study results | Plain language summary | Publication (if available) |
|---|---|---|---|---|---|---|---|
| Restless Legs Syndrome | An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome | Phase 3 |
SP0793
Completed |
NCT00263068 | 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. | ||
| 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 | Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects | Phase 3 |
SP0791
Completed |
NCT00498108 2005-002611-25 |
LINK
|
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 | 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 | ||
| 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 | |
| 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 | 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 | 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 | 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 | ||
| 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
|
Giladi et al. J Neural Transm;2010;117(12);1395-1399. | |
| 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 | Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome | Phase 3 |
SP0792
Completed |
NCT00135993 | Hening et al. Mov Disord;2010;25(11);1675-1683. | ||
| Parkinson's Disease | Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine | Phase 3 |
SP0908
Completed |
NCT00593606 |
LINK
|
Kim et al. BMC Neurol;2011;11;100. | |
| 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
|
LeWitt et al. Clin Neuropharmacol;2007;30(5);256-265. | |
| 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 | 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 | 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 |
LeWitt et al. Neurology;2007;68;16;1262-1267 | |||
| 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 | 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. | |
| Restless Legs Syndrome | Rotigotine Restless Legs Syndrome Dose Finding Trial | Phase 2 |
SP0709
Completed |
NCT00243217 | Oertel et al. Sleep Med;2008;9(3);228-239. | ||
| 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
|
Oertel et al. Sleep Med;2010;11(9);848-856. | |
| 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 | Poewe et al. Lancet Neurol;2007;6(6);513-520. | ||
| 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. | |
| 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
|
Trenkwalder et al. Lancet Neurol;2008;7(7);595-604. | |
| 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 | 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
|
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 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. | |
| 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
|
Zhang et al. Parkinsonism Relat Disord 2016, 28, 49-55 | |
| 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
|
Zhang et al. Parkinsonism Relat Disord 2017, 44, 6-12 | |
| 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 |
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| 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 |
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| Fibromyalgia | The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults. (SP888) | Phase 2 |
SP0888
Completed |
NCT00464737 |
LINK
|
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| 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 |
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| 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 |
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| Restless Legs Syndrome | A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause | Phase 3 |
SP1006
Terminated |
NCT03728933 2018-001445-13 |
LINK LINK |
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| 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
|
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| 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 |
NCT03992196 2021-003403-18 |
LINK
|
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| Parkinson's Disease | Rotigotine in Adults for the Treatment of Early Parkinson’s Disease | Phase 2 |
SP506
Completed |
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| Parkinson's Disease | Rotigotine in Adults for the Treatment of Early Parkinson’s Disease | Phase 3 |
SP512
Completed |
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| Parkinson's Disease | Rotigotine in Adults for the Treatment of Early Parkinson’s Disease | Phase 3 |
SP513
Completed |