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Neupro® (rotigotine)

 

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Disease area
studied
Abbreviated title Phase Study ID Registry database Study results Plain language summary Publication (if available)
Parkinson's Disease Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain (DOLORES) Phase 4 PD0004
Completed
NCT01744496
2012-002608-42
LINK
LINK
 
  Rascol et al.  J Clin Pharmacol;2016;56;7;852-861
Parkinson's Disease Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy (BRIGHT) Phase 4 PD0005
Completed
NCT01782222
2012-002840-26
LINK
LINK
 
  Hauser et al. BMC Neurol;6-7-2016;16;1;90
Parkinson's Disease A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease Phase 4 PD0009
Completed
NCT01711866 LINK   Chung et al. Expert Opin Pharmacother;2015; 16;7;961-970
Parkinson's Disease A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease Phase 3 PD0015
Completed
NCT01723904 LINK   Kim et al. Movement Disorders;2013;28;suppl.1;S220, abs 618
17th International Congress of Parkinson's Disease and Movement Disorders (MDS), June 16-20, 2013;Sidney, Australia
Parkinson's Disease
 
Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management Phase 4  PD0049
Completed
NCT03103919    
Restless Legs Syndrome Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS) (RESTORE) Phase 3 RL0003
Completed
NCT01569464 LINK    
Parkinson's Disease A trial to assess the efficacy, safety, and tolerability of escalating transdermaldoses of rotigotine (SPM 962) in subjects with early-stage Parkinson’s disease Phase 2 SP0506
Completed
  PDF    
Parkinson's Disease A trial to assess the efficacy and safety of the rotigotine patch in subjects with early stage,idiopathic Parkinson’s disease (Part 1) Phase 3 SP0512
Completed
  PDF PDF Watts et al. Neurology;2007; 68;272-276
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
    PDF 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   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 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 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 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
LINK
LINK
 
   
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
LINK
LINK
 
  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
LINK
LINK
 
  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
LINK
LINK
 
  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
LINK
LINK
 
  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
Ongoing
NCT01498120
2016-000635-40
LINK
LINK
   
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   PDF Zhang et al.  Parkinsonism Relat Disord 2017 epub, 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