Transdermal Rotigotine User Surveillance Study

Idiopathic Parkinson Disease Clinical Trial

— TRUST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599339
• Other study ID #: SP0854
• Status: Completed
• Start date: June 2006
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2195
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Parkinson Disease
• Parkinson Disease

Locations

Country	Name	City	State
Czechia	813	Chomutov
Czechia	808	Hradec Kralove
Czechia	822	Hradec Kralove
Czechia	811	Litomysl
Czechia	803	Ostrava-Poruba
Czechia	809	Pardubice
Czechia	817	Pisek
Czechia	814	Plzen-Lochotin
Czechia	805	Praha 1
Czechia	829	Praha 10
Czechia	825	Praha 4
Czechia	804	Praha 5
Czechia	832	Rakovnik
Czechia	819	Zlin
Denmark	752	Aalborg
Denmark	751	Aarhus
Denmark	750	Sonderborg
Germany	242	Aalen
Germany	143	Achim
Germany	240	Alzenau
Germany	145	Annaberg-Buchholz
Germany	245	Aschaffenburg
Germany	185	Augsburg
Germany	130	Bad Neustadt
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	203	Böblingen
Germany	149	Bochum
Germany	151	Bochum
Germany	216	Bochum
Germany	220	Brandenburg
Germany	236	Butzbach
Germany	237	Butzbach
Germany	133	Dresden
Germany	199	Dresden
Germany	232	Dresden
Germany	219	Duisburg
Germany	112	Düsseldorf
Germany	141	Düsseldorf
Germany	129	Emmendingen
Germany	162	Erbach
Germany	202	Flensburg
Germany	156	Friedberg (Hessen)
Germany	247	Gera
Germany	223	Greifswald
Germany	249	Hagen
Germany	167	Halle (Saale)
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
Germany	106	Karlstadt
Germany	244	Kassel
Germany	124	Köln
Germany	153	Köln
Germany	179	Köln
Germany	175	Leutkirch
Germany	152	Lutherstadt Eisleben
Germany	230	Magdeburg
Germany	235	Mannheim
Germany	148	München
Germany	189	München
Germany	191	München
Germany	169	Naumburg (Saale)
Germany	182	Neuburg
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
Greece	607	Alexandroupoli
Greece	600	Athens
Greece	602	Athens
Greece	605	Athens
Greece	610	Athens
Greece	608	Chaidari
Greece	611	Marousi
Greece	601	Melissia
Greece	604	Thessaloniki
Greece	606	Thessaloniki
Italy	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
Mexico	704	Aguascalientes
Mexico	707	Guadalajara
Mexico	703	Merida
Mexico	701	Mexico D.F.
Mexico	702	Mexico D.F.
Mexico	706	Monterrey
Mexico	710	Morelia Michoacan
Mexico	708	San Luis Potosi
Mexico	705	Zapopan
Romania	425	Arad
Romania	406	Bacau
Romania	407	Bacau
Romania	417	Bistrita
Romania	412	Bucharest
Romania	418	Bucharest
Romania	423	Bucharest
Romania	424	Bucharest
Romania	434	Bucharest
Romania	436	Bucharest
Romania	427	Constanta
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	Orastie
Romania	401	Pitesti
Romania	428	Pitesti
Romania	435	Râmnicu Vâlcea
Romania	422	Resista
Romania	408	Satu Mare
Romania	429	Sfantu Gheorghe
Romania	413	Sibiu
Romania	416	Targoviste
Romania	432	Târgu-Mures
Romania	414	Timisoara
Romania	421	Timisoara
Slovakia	521	Banska Bystrica
Slovakia	500	Bratislava
Slovakia	502	Bratislava
Slovakia	507	Bratislava
Slovakia	514	Bratislava
Slovakia	501	Dolni Kubin
Slovakia	505	Dubnica Nad Vahom
Slovakia	522	Krompachy
Slovakia	520	Lucenec
Slovakia	508	Skalica
Slovakia	503	Spisska Nova Ves
Slovakia	509	Stara Lubovna
Slovakia	510	Trencin
Slovakia	519	Vranov
Slovakia	516	Zilina
Slovakia	518	Zvolen
Spain	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
Switzerland	355	Biel
Switzerland	353	Sargans
Switzerland	354	St. Gallen
Switzerland	351	Tschugg
Switzerland	350	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Czechia,  Denmark,  Germany,  Greece,  Italy,  Mexico,  Romania,  Slovakia,  Spain,  Switzerland, 

References & Publications (1)

Müller 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 ( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	From Baseline to Visit 7 (Month 33)
Secondary	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).	From Baseline to Visit 7 (Month 33)
Secondary	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).	33 months
Secondary	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.	33 months
Secondary	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	33 months
Secondary	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.	33 months

External Links

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