Idiopathic Parkinson DiseaseTRUSTNCT00599339

Transdermal Rotigotine User Surveillance Study

An observational study of Idiopathic Parkinson Disease, run by UCB Pharma at 211 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Idiopathic Parkinson Disease
How many people: 2,195 participants
Where: 211 sitesin 10 countries
Study dates: Jun 2006to Apr 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Primary Care

Who may be able to join

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

Who cannot join

Patients who are unable to comply with study requirements

Trial locations and contacts

211 sites in 10 countries.

Country

City, postcode or hospital

211 sites in 10 countries

Germany94 sites

242
Aalen
143
Achim
240
Alzenau in Unterfranken
145
Annaberg-Buchholz
245
Aschaffenburg
185
Augsburg
130
Bad Neustadt an der Saale
131
Bamberg
103
Berg
102
Berlin
110
Berlin
113
Berlin
119
Berlin
142
Berlin
150
Berlin
157
Berlin
163
Berlin
166
Berlin
195
Berlin
198
Berlin
206
Berlin
207
Berlin
224
Berlin
243
Berlin
108
Bielefeld
127
Bielefield
178
Blankenburg (Harz)
203
Böblingen
149
Bochum
151
Bochum
216
Bochum
220
Brandenburg
236
Butzbach
237
Butzbach
124
Cologne
153
Cologne
179
Cologne
133
Dresden
199
Dresden
232
Dresden
219
Duisburg
112
Düsseldorf
141
Düsseldorf
152
Eisleben Lutherstadt
129
Emmendingen
162
Erbach im Odenwald
202
Flensburg
156
Friedberg (Hessen)
247
Gera
223
Greifswald
249
Hagen
167
Halle
121
Hamburg
140
Hamburg
176
Hamburg
217
Hamburg
241
Heidenheim
138
Hemmoor
173
Herborn
214
Jena
248
Jena
181
Jülich
105
Karlstadt am Main
106
Karlstadt am Main
244
Kassel
175
Leutkirch
230
Magdeburg
235
Mannheim
148
München
189
München
191
München
169
Naumburg
182
Neuburg am Inn
118
Oberhausen
164
Oberursel (Taunus)
171
Oldenburg
196
Oranienburg
114
Rheda-Wiedenbrück
188
Rottenburg Am Neckar
187
Schriesheim
107
Schwerin
134
Singen
229
Stadtroda
180
Starnberg
146
Stuttgart
186
Stuttgart
211
Stuttgart
226
Tübingen
139
Ulm
172
Unterhaching
239
Westerstede
233
Wiesbaden
122
Wolfach
194
Zwickau

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Romania32 sites

425
Arad
406
Bacau
407
Bacau
417
Bistriţa
412
Bucharest
418
Bucharest
423
Bucharest
424
Bucharest
434
Bucharest
436
Bucharest
427
Constanța
411
Craiova
433
Craiova
404
Drobeta-Turnu Severin
437
Foscani, Jud. Vrancea
405
Galati
420
Galati
403
Lasi
409
Lasi
415
Medgidia
402
Orăştie
401
Piteşti
428
Piteşti
435
Râmnicu Vâlcea
422
Resista
408
Satu Mare
429
Sfantu Gheorghe
413
Sibiu
416
Targoviste
432
Târgu Mureş
414
Timișoara
421
Timișoara

Other trials in Romania

Italy16 sites

664
Acquaviva delle Fonti
654
Ancona
665
Bari
655
Cagliari
666
Casarano
662
Cassino
653
Ferrara
661
Imperia
650
Lido di Camaiore
663
Lodi
658
Messina
660
Naples
667
Pisa
657
Roma
656
San Giovannni Rotondo
669
Torino

Other trials in Italy

Slovakia16 sites

521
Banská Bystrica
500
Bratislava
502
Bratislava
507
Bratislava
514
Bratislava
501
Dolný Kubín
505
Dubnica nad Váhom
522
Krompachy
520
Lučenec
508
Skalica
503
Spišská Nová Ves
509
Stará Ľubovňa
510
Trenčín
519
Vranov nad Topľou
516
Žilina
518
Zvolen

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Czechia14 sites

813
Chomutov
808
Hradec Králové
822
Hradec Králové
811
Litomyšl
803
Ostrava-Poruba
809
Pardubice
817
Písek
814
Plzen-Lochotin
804
Prague
805
Prague
825
Prague
829
Prague
832
Rakovník
819
Zlín

Other trials in Czechia

Spain12 sites

308
Alzira (Valencia)
320
Badalona
301
Barcelona
303
Barcelona
305
Barcelona
318
Barcelona
315
Burgos
313
Ciudad Real
306
Madrid
307
Madrid
314
Palma de Mallorca
312
Valencia

Other trials in Spain

Greece10 sites

607
Alexandroupoli
600
Athens
602
Athens
605
Athens
610
Athens
608
Chaïdári
611
Marousi
601
Melíssia
604
Thessaloniki
606
Thessaloniki

Other trials in Greece

Mexico9 sites

704
Aguascalientes
707
Guadalajara
703
Mérida
701
Mexico City
702
Mexico City
706
Monterrey
710
Morelia Michoacan
708
San Luis Potosí City
705
Zapopan

Other trials in Mexico

Switzerland5 sites

355
Biel
354
Sankt Gallen
353
Sargans
351
Tschugg
350
Zurich

Other trials in Switzerland

Denmark3 sites

752
Aalborg
751
Aarhus
750
Sønderborg

Other trials in Denmark

About this study

Official title: A Naturalistic, Multisite, Observational Study of Rotigotine Transdermal Patch and Other Currently Prescribed Therapies in Patients With Idiopathic Parkinson's Disease

Read the detailed description

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

Conditions: Idiopathic Parkinson Disease
Keywords: Rotigotine, Neupro
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00599339
Study group	Role	What they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 33 months
Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)
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.
Measured: 33 months
Hoehn & Yahr Stage at Visit 7 (Month 33)
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
Measured: 33 months
Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 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.
Measured: 33 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Apr 2014

First posted23 Jan 2008 (estimated)
Study startJun 2006
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Idiopathic Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,195 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00599339
Sponsor's protocol ID: SP0854
Acronym: TRUST
Status last verified: Jul 2015
First submitted: 10 Jan 2008
Last updated: 9 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29484495

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Idiopathic Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Naturalistic, Multisite, Observational Study of Rotigotine Transdermal Patch and Other Currently Prescribed Therapies in Patients With Idiopathic Parkinson's Disease
ClinicalTrials.gov ID: NCT00599339
Acronym / sponsor ID: TRUST / SP0854
Conditions: Idiopathic Parkinson Disease
Keywords: Rotigotine, Neupro
Study type: Observational
Recruitment status: Completed
Enrolment: 2,195 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 23 Jan 2008 (estimated)
Results: Posted 29 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 5

Arm	Type	Receives
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

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Primary Care

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

Patients who are unable to comply with study requirements

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)
Time frame: 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).

6 secondary outcomes

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)
Time frame: 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)
Time frame: 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)
Time frame: 33 months
Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)
Time frame: 33 months
Hoehn & Yahr Stage at Visit 7 (Month 33)
Time frame: 33 months
Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months)
Time frame: 33 months

Results and safety

Results posted to the registry on 29 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall	2,195	1,531

Primary outcome: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)

Time frame: From Baseline to Visit 7 (Month 33). Mean (Standard Deviation). Unit: units on a scale

Measure	Neupro Monotherapy (>= 3 Months) n = 203	Neupro Monotherapy (< 3 Months) n = 11	Other Dopamine Agonist (>= 3 Months) n = 145	Other Dopamine Agonist (< 3 Months) n = 10	L-Dopa Monotherapy (>= 3 Months) n = 233	L-Dopa Monotherapy (< 3 Months) n = 23	Multiple Dopamine Agonists (>= 3 Months) n = 13	Multiple Dopamine Agonists (< 3 Months) n = 2	Neupro + L-Dopa (>= 3 Months) n = 400	Neupro + L-Dopa (< 3 Months) n = 6	Other Dopamine Agonist + L-Dopa (>= 3 Months) n = 377	Other Dopamine Agonist + L-Dopa (< 3 Months) n = 11	Multiple Dopamine Agonists + L-Dopa (>= 3 Months) n = 35	Multiple Dopamine Agonists + L-Dopa (< 3 Months) n = 2	Not Treated (>= 3 Months) n = 13	Not Treated (< 3 Months) n = 36
Value	-2.5 (14.7)	-2.5 (10.3)	-2.2 (11.1)	-5.6 (16.9)	0.2 (13.2)	0.0 (12.2)	-1.2 (13.8)	3.5 (6.4)	-1.2 (14.2)	-1.5 (17.5)	-2.5 (13.9)	8.6 (13.5)	1.5 (14.7)	20.0 (29.7)	-3.2 (10.8)	4.1 (15.0)

Population analysed: All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS). Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) were collected during the course of the study from Baseline (Visit 1) up to Visit 7 (Month 33 ± 30 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Associated With Rotigotine	261 of 1,390 (18.8%)	237 of 1,390 (17.1%)	Not reported
Not Associated With Rotigotine	269 of 1,328 (20.3%)	245 of 1,328 (18.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29484495Muller 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.
Product InformationLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

211 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Parkinson Disease, run by UCB Pharma at 211 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in Germany, Romania, Italy, Slovakia, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) (time frame: From Baseline to Visit 7 (Month 33)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00599339, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.