Transdermal Rotigotine User Surveillance Study

Completed

Conditions: Idiopathic Parkinson Disease

Registration Number: NCT00599339

Lead Sponsor: UCB Pharma

Brief Summary: This study will be conducted in an observational multiple-cohort design aimed at acquiring clinical, treatment, health status, and economic data. Patients with Parkinson's disease (PD) will be enrolled.

Detailed Description: All patients attending the physician and fulfilling the eligibility criteria are included.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2195

Inclusion Criteria

Patients with idiopathic early-stage Parkinson's Disease requiring dopaminergic monotherapy (rotigotine, other dopamine agonists or levodopa) at study onset
Patients with advanced-stage Parkinson's Disease requiring dopaminergic therapy with levodopa in combination with rotigotine or other dopamine agonists at study onset

Exclusion Criteria

Patients who are unable to comply with study requirements

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)	From Baseline to Visit 7 (Month 33)	The Unified Parkinson's disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)	From Baseline to Visit 7 (Month 33)	The Unified Parkinson's disease rating scale (UPDRS) question 32 of part IV asks. "What Proportion of the waking day are dyskinesias present?" Answers range from 0 (None) to 4 (76-100 % of the day).
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33)	From Baseline to Visit 7 (Month 33)	The Unified Parkinson's disease rating scale (UPDRS) Part IV question 33 asks for complications of therapy in the past week, through the question "How disabling are the dyskinesias ? " Answers range from 0 (Not disabling) to 4 (Completely disabling).
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)	33 months	The Unified Parkinson's disease rating scale (UPDRS) Part IV question 39 asks "What proportion of the waking day is the patient "off", on average?" Answers range from 0 (None) to 4 (76-100 % of the day).
Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)	33 months	The NADCS assesses sleep-related motor complaints including nocturnal akinesia, dystonia and painful cramps by an ordinal severity scale. The NADCS total score ranges from 0 (normal) to 4 (maximum severity). NADCS value was missing for one subject at Visit 7.
Hoehn & Yahr Stage at Visit 7 (Month 33)	33 months	The Hoehn and Yahr staging of Parkinson's disease in the "on" stage, if applicable, had to be completed by the physician. Possible staging: * 0 No signs of disease * 1 Unilateral disease * 2 Bilateral disease without impairment of balance * 3 Mild to moderate bilateral disease, some postural instability, physically dependent * 4 Severe disability, still able to walk or stand unassisted * 5 Wheelchair bound or bedridden unless aided
Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months)	33 months	The analysis was performed for the non-disjunctive classification into patients at risk to develop an Adverse Event associated with Rotigotine and patients at risk to develop an Adverse Event not associated with Rotigotine.

Trial Locations

Locations (211): 407
🇷🇴
Bacau, Romania
423
🇷🇴
Bucharest, Romania
502
🇸🇰
Bratislava, Slovakia
514
🇸🇰
Bratislava, Slovakia
405
🇷🇴
Galati, Romania
420
🇷🇴
Galati, Romania
413
🇷🇴
Sibiu, Romania
416
🇷🇴
Targoviste, Romania
414
🇷🇴
Timisoara, Romania
507
🇸🇰
Bratislava, Slovakia
421
🇷🇴
Timisoara, Romania
432
🇷🇴
Târgu-Mureş, Romania
654
🇮🇹
Ancona, Italy
808
🇨🇿
Hradec Kralove, Czechia
822
🇨🇿
Hradec Kralove, Czechia
829
🇨🇿
Praha 10, Czechia
752
🇩🇰
Aalborg, Denmark
832
🇨🇿
Rakovnik, Czechia
198
🇩🇪
Berlin, Germany
195
🇩🇪
Berlin, Germany
133
🇩🇪
Dresden, Germany
247
🇩🇪
Gera, Germany
202
🇩🇪
Flensburg, Germany
223
🇩🇪
Greifswald, Germany
182
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Neuburg, Germany
171
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Oldenburg, Germany
180
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Starnberg, Germany
134
🇩🇪
Singen, Germany
229
🇩🇪
Stadtroda, Germany
146
🇩🇪
Stuttgart, Germany
186
🇩🇪
Stuttgart, Germany
122
🇩🇪
Wolfach, Germany
194
🇩🇪
Zwickau, Germany
611
🇬🇷
Marousi, Greece
601
🇬🇷
Melissia, Greece
604
🇬🇷
Thessaloniki, Greece
606
🇬🇷
Thessaloniki, Greece
666
🇮🇹
Casarano, Italy
662
🇮🇹
Cassino, Italy
655
🇮🇹
Cagliari, Italy
665
🇮🇹
Bari, Italy
653
🇮🇹
Ferrara, Italy
661
🇮🇹
Imperia, Italy
707
🇲🇽
Guadalajara, Mexico
703
🇲🇽
Merida, Mexico
705
🇲🇽
Zapopan, Mexico
417
🇷🇴
Bistrita, Romania
706
🇲🇽
Monterrey, Mexico
406
🇷🇴
Bacau, Romania
412
🇷🇴
Bucharest, Romania
434
🇷🇴
Bucharest, Romania
436
🇷🇴
Bucharest, Romania
424
🇷🇴
Bucharest, Romania
427
🇷🇴
Constanta, Romania
411
🇷🇴
Craiova, Romania
433
🇷🇴
Craiova, Romania
401
🇷🇴
Pitesti, Romania
428
🇷🇴
Pitesti, Romania
415
🇷🇴
Medgidia, Romania
402
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Orastie, Romania
429
🇷🇴
Sfantu Gheorghe, Romania
521
🇸🇰
Banska Bystrica, Slovakia
500
🇸🇰
Bratislava, Slovakia
501
🇸🇰
Dolni Kubin, Slovakia
522
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Krompachy, Slovakia
505
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Dubnica Nad Vahom, Slovakia
520
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Lucenec, Slovakia
508
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Skalica, Slovakia
503
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Spisska Nova Ves, Slovakia
510
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Trencin, Slovakia
509
🇸🇰
Stara Lubovna, Slovakia
518
🇸🇰
Zvolen, Slovakia
303
🇪🇸
Barcelona, Spain
305
🇪🇸
Barcelona, Spain
308
🇪🇸
Alzira (Valencia), Spain
301
🇪🇸
Barcelona, Spain
315
🇪🇸
Burgos, Spain
320
🇪🇸
Badalona, Spain
318
🇪🇸
Barcelona, Spain
313
🇪🇸
Ciudad Real, Spain
307
🇪🇸
Madrid, Spain
306
🇪🇸
Madrid, Spain
355
🇨🇭
Biel, Switzerland
314
🇪🇸
Palma de Mallorca, Spain
354
🇨🇭
St. Gallen, Switzerland
312
🇪🇸
Valencia, Spain
353
🇨🇭
Sargans, Switzerland
751
🇩🇰
Aarhus, Denmark
150
🇩🇪
Berlin, Germany
163
🇩🇪
Berlin, Germany
166
🇩🇪
Berlin, Germany
224
🇩🇪
Berlin, Germany
216
🇩🇪
Bochum, Germany
220
🇩🇪
Brandenburg, Germany
112
🇩🇪
Düsseldorf, Germany
141
🇩🇪
Düsseldorf, Germany
140
🇩🇪
Hamburg, Germany
162
🇩🇪
Erbach, Germany
138
🇩🇪
Hemmoor, Germany
105
🇩🇪
Karlstadt, Germany
244
🇩🇪
Kassel, Germany
124
🇩🇪
Köln, Germany
153
🇩🇪
Köln, Germany
169
🇩🇪
Naumburg (Saale), Germany
189
🇩🇪
München, Germany
191
🇩🇪
München, Germany
233
🇩🇪
Wiesbaden, Germany
701
🇲🇽
Mexico D.F., Mexico
702
🇲🇽
Mexico D.F., Mexico
803
🇨🇿
Ostrava-Poruba, Czechia
814
🇨🇿
Plzen-Lochotin, Czechia
804
🇨🇿
Praha 5, Czechia
819
🇨🇿
Zlin, Czechia
809
🇨🇿
Pardubice, Czechia
110
🇩🇪
Berlin, Germany
813
🇨🇿
Chomutov, Czechia
805
🇨🇿
Praha 1, Czechia
817
🇨🇿
Pisek, Czechia
811
🇨🇿
Litomysl, Czechia
825
🇨🇿
Praha 4, Czechia
178
🇩🇪
Blankenburg (Harz), Germany
750
🇩🇰
Sonderborg, Denmark
102
🇩🇪
Berlin, Germany
242
🇩🇪
Aalen, Germany
113
🇩🇪
Berlin, Germany
103
🇩🇪
Berg, Germany
240
🇩🇪
Alzenau, Germany
145
🇩🇪
Annaberg-Buchholz, Germany
131
🇩🇪
Bamberg, Germany
130
🇩🇪
Bad Neustadt, Germany
143
🇩🇪
Achim, Germany
245
🇩🇪
Aschaffenburg, Germany
206
🇩🇪
Berlin, Germany
108
🇩🇪
Bielefeld, Germany
142
🇩🇪
Berlin, Germany
129
🇩🇪
Emmendingen, Germany
127
🇩🇪
Bielefield, Germany
156
🇩🇪
Friedberg (Hessen), Germany
119
🇩🇪
Berlin, Germany
157
🇩🇪
Berlin, Germany
149
🇩🇪
Bochum, Germany
151
🇩🇪
Bochum, Germany
199
🇩🇪
Dresden, Germany
232
🇩🇪
Dresden, Germany
237
🇩🇪
Butzbach, Germany
203
🇩🇪
Böblingen, Germany
219
🇩🇪
Duisburg, Germany
167
🇩🇪
Halle (Saale), Germany
121
🇩🇪
Hamburg, Germany
176
🇩🇪
Hamburg, Germany
249
🇩🇪
Hagen, Germany
241
🇩🇪
Heidenheim, Germany
217
🇩🇪
Hamburg, Germany
173
🇩🇪
Herborn, Germany
214
🇩🇪
Jena, Germany
175
🇩🇪
Leutkirch, Germany
181
🇩🇪
Jülich, Germany
179
🇩🇪
Köln, Germany
248
🇩🇪
Jena, Germany
106
🇩🇪
Karlstadt, Germany
708
🇲🇽
San Luis Potosi, Mexico
425
🇷🇴
Arad, Romania
664
🇮🇹
Acquaviva Delle Fonti, Italy
663
🇮🇹
Lodi, Italy
658
🇮🇹
Messina, Italy
107
🇩🇪
Schwerin, Germany
187
🇩🇪
Schriesheim, Germany
152
🇩🇪
Lutherstadt Eisleben, Germany
667
🇮🇹
Pisa, Italy
669
🇮🇹
Torino, Italy
605
🇬🇷
Athens, Greece
235
🇩🇪
Mannheim, Germany
230
🇩🇪
Magdeburg, Germany
148
🇩🇪
München, Germany
211
🇩🇪
Stuttgart, Germany
188
🇩🇪
Rottenburg Am Neckar, Germany
118
🇩🇪
Oberhausen, Germany
164
🇩🇪
Oberursel (Taunus), Germany
607
🇬🇷
Alexandroupoli, Greece
600
🇬🇷
Athens, Greece
602
🇬🇷
Athens, Greece
610
🇬🇷
Athens, Greece
114
🇩🇪
Rheda-Wiedenbrück, Germany
196
🇩🇪
Oranienburg, Germany
226
🇩🇪
Tübingen, Germany
139
🇩🇪
Ulm, Germany
172
🇩🇪
Unterhaching, Germany
418
🇷🇴
Bucharest, Romania
608
🇬🇷
Chaidari, Greece
704
🇲🇽
Aguascalientes, Mexico
650
🇮🇹
Lido Di Camaiore, Italy
660
🇮🇹
Napoli, Italy
656
🇮🇹
San Giovannni Rotondo, Italy
657
🇮🇹
Roma, Italy
710
🇲🇽
Morelia Michoacan, Mexico
404
🇷🇴
Drobeta Turnu Severin, Romania
403
🇷🇴
Lasi, Romania
435
🇷🇴
Râmnicu Vâlcea, Romania
408
🇷🇴
Satu Mare, Romania
437
🇷🇴
Foscani, Jud. Vrancea, Romania
409
🇷🇴
Lasi, Romania
422
🇷🇴
Resista, Romania
519
🇸🇰
Vranov, Slovakia
516
🇸🇰
Zilina, Slovakia
351
🇨🇭
Tschugg, Switzerland
350
🇨🇭
Zürich, Switzerland
207
🇩🇪
Berlin, Germany
243
🇩🇪
Berlin, Germany
239
🇩🇪
Westerstede, Germany
185
🇩🇪
Augsburg, Germany
236
🇩🇪
Butzbach, Germany