Transdermal Rotigotine User Surveillance Study
TRUST
A Naturalistic, Multisite, Observational Study of Rotigotine Transdermal Patch and Other Currently Prescribed Therapies in Patients With Idiopathic Parkinson's Disease
1 other identifier
observational
2,195
10 countries
211
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2006
Longer than P75 for all trials
211 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 10, 2008
CompletedFirst Posted
Study publicly available on registry
January 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
April 29, 2015
CompletedAugust 9, 2018
July 1, 2015
7.8 years
January 10, 2008
April 10, 2015
July 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at 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).
From Baseline to Visit 7 (Month 33)
Secondary Outcomes (6)
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)
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)
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)
33 months
Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)
33 months
Hoehn & Yahr Stage at Visit 7 (Month 33)
33 months
- +1 more secondary outcomes
Study Arms (5)
Neupro
Neupro at study onset
Dopamine Agonist
Other Dopamine-Agonist at study onset
L-Dopa
L-Dopa
Neupro + L-Dopa
Neupro in combination with L-Dopa at study onset
Dopamine Agonist + L-Dopa
Other Dopamine Agonist in combination with L-Dopa at study onset
Eligibility Criteria
Primary Care
You may qualify if:
- 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
You may not qualify if:
- Patients who are unable to comply with study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (211)
813
Chomutov, Czechia
808
Hradec Králové, Czechia
822
Hradec Králové, Czechia
811
Litomyšl, Czechia
803
Ostrava-Poruba, Czechia
809
Pardubice, Czechia
817
Písek, Czechia
814
Plzen-Lochotin, Czechia
804
Prague, Czechia
805
Prague, Czechia
825
Prague, Czechia
829
Prague, Czechia
832
Rakovník, Czechia
819
Zlín, Czechia
752
Aalborg, Denmark
751
Aarhus, Denmark
750
Sønderborg, Denmark
242
Aalen, Germany
143
Achim, Germany
240
Alzenau in Unterfranken, Germany
145
Annaberg-Buchholz, Germany
245
Aschaffenburg, Germany
185
Augsburg, Germany
130
Bad Neustadt an der Saale, Germany
131
Bamberg, Germany
103
Berg, Germany
102
Berlin, Germany
110
Berlin, Germany
113
Berlin, Germany
119
Berlin, Germany
142
Berlin, Germany
150
Berlin, Germany
157
Berlin, Germany
163
Berlin, Germany
166
Berlin, Germany
195
Berlin, Germany
198
Berlin, Germany
206
Berlin, Germany
207
Berlin, Germany
224
Berlin, Germany
243
Berlin, Germany
108
Bielefeld, Germany
127
Bielefield, Germany
178
Blankenburg (Harz), Germany
149
Bochum, Germany
151
Bochum, Germany
216
Bochum, Germany
203
Böblingen, Germany
220
Brandenburg, Germany
236
Butzbach, Germany
237
Butzbach, Germany
124
Cologne, Germany
153
Cologne, Germany
179
Cologne, Germany
133
Dresden, Germany
199
Dresden, Germany
232
Dresden, Germany
219
Duisburg, Germany
112
Düsseldorf, Germany
141
Düsseldorf, Germany
152
Eisleben Lutherstadt, Germany
129
Emmendingen, Germany
162
Erbach im Odenwald, Germany
202
Flensburg, Germany
156
Friedberg (Hessen), Germany
247
Gera, Germany
223
Greifswald, Germany
249
Hagen, Germany
167
Halle, Germany
121
Hamburg, Germany
140
Hamburg, Germany
176
Hamburg, Germany
217
Hamburg, Germany
241
Heidenheim, Germany
138
Hemmoor, Germany
173
Herborn, Germany
214
Jena, Germany
248
Jena, Germany
181
Jülich, Germany
105
Karlstadt am Main, Germany
106
Karlstadt am Main, Germany
244
Kassel, Germany
175
Leutkirch, Germany
230
Magdeburg, Germany
235
Mannheim, Germany
148
München, Germany
189
München, Germany
191
München, Germany
169
Naumburg, Germany
182
Neuburg am Inn, Germany
118
Oberhausen, Germany
164
Oberursel (Taunus), Germany
171
Oldenburg, Germany
196
Oranienburg, Germany
114
Rheda-Wiedenbrück, Germany
188
Rottenburg Am Neckar, Germany
187
Schriesheim, Germany
107
Schwerin, Germany
134
Singen, Germany
229
Stadtroda, Germany
180
Starnberg, Germany
146
Stuttgart, Germany
186
Stuttgart, Germany
211
Stuttgart, Germany
226
Tübingen, Germany
139
Ulm, Germany
172
Unterhaching, Germany
239
Westerstede, Germany
233
Wiesbaden, Germany
122
Wolfach, Germany
194
Zwickau, Germany
607
Alexandroupoli, Greece
600
Athens, Greece
602
Athens, Greece
605
Athens, Greece
610
Athens, Greece
608
Chaïdári, Greece
611
Marousi, Greece
601
Melíssia, Greece
604
Thessaloniki, Greece
606
Thessaloniki, Greece
664
Acquaviva delle Fonti, Italy
654
Ancona, Italy
665
Bari, Italy
655
Cagliari, Italy
666
Casarano, Italy
662
Cassino, Italy
653
Ferrara, Italy
661
Imperia, Italy
650
Lido di Camaiore, Italy
663
Lodi, Italy
658
Messina, Italy
660
Napoli, Italy
667
Pisa, Italy
657
Roma, Italy
656
San Giovannni Rotondo, Italy
669
Torino, Italy
704
Aguascalientes, Mexico
707
Guadalajara, Mexico
701
Mexico City, Mexico
702
Mexico City, Mexico
703
Mérida, Mexico
706
Monterrey, Mexico
710
Morelia Michoacan, Mexico
708
San Luis Potosí City, Mexico
705
Zapopan, Mexico
425
Arad, Romania
406
Bacau, Romania
407
Bacau, Romania
417
Bistriţa, Romania
412
Bucharest, Romania
418
Bucharest, Romania
423
Bucharest, Romania
424
Bucharest, Romania
434
Bucharest, Romania
436
Bucharest, Romania
427
Constanța, Romania
411
Craiova, Romania
433
Craiova, Romania
404
Drobeta-Turnu Severin, Romania
437
Foscani, Jud. Vrancea, Romania
405
Galati, Romania
420
Galati, Romania
403
Lasi, Romania
409
Lasi, Romania
415
Medgidia, Romania
402
Orăştie, Romania
401
Piteşti, Romania
428
Piteşti, Romania
435
Râmnicu Vâlcea, Romania
422
Resista, Romania
408
Satu Mare, Romania
429
Sfântu Gheorghe, Romania
413
Sibiu, Romania
416
Târgovişte, Romania
432
Târgu Mureş, Romania
414
Timișoara, Romania
421
Timișoara, Romania
521
Banská Bystrica, Slovakia
500
Bratislava, Slovakia
502
Bratislava, Slovakia
507
Bratislava, Slovakia
514
Bratislava, Slovakia
501
Dolný Kubín, Slovakia
505
Dubnica nad Váhom, Slovakia
522
Krompachy, Slovakia
520
Lučenec, Slovakia
508
Skalica, Slovakia
503
Spišská Nová Ves, Slovakia
509
Stará Ľubovňa, Slovakia
510
Trenčín, Slovakia
519
Vranov nad Topľou, Slovakia
518
Zvolen, Slovakia
516
Žilina, Slovakia
308
Alzira (Valencia), Spain
320
Badalona, Spain
301
Barcelona, Spain
303
Barcelona, Spain
305
Barcelona, Spain
318
Barcelona, Spain
315
Burgos, Spain
313
Ciudad Real, Spain
306
Madrid, Spain
307
Madrid, Spain
314
Palma de Mallorca, Spain
312
Valencia, Spain
355
Biel, Switzerland
354
Sankt Gallen, Switzerland
353
Sargans, Switzerland
351
Tschugg, Switzerland
350
Zurich, Switzerland
Related Publications (1)
Muller T, Tolosa E, Badea L, Asgharnejad M, Grieger F, Markowitz M, Nondonfaz X, Bauer L, Timmermann L. An observational study of rotigotine transdermal patch and other currently prescribed therapies in patients with Parkinson's disease. J Neural Transm (Vienna). 2018 Jun;125(6):953-963. doi: 10.1007/s00702-018-1860-x. Epub 2018 Feb 26.
PMID: 29484495RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2008
First Posted
January 23, 2008
Study Start
June 1, 2006
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
August 9, 2018
Results First Posted
April 29, 2015
Record last verified: 2015-07