Clinical trial NCT00599339: Transdermal Rotigotine User Surveillance Study
Official title: A Naturalistic, Multisite, Observational Study of Rotigotine Transdermal Patch and Other Currently Prescribed Therapies in Patients With Idiopathic Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Parkinson Disease
Keywords: Rotigotine
Neupro
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-01-23
Enrollment: 2195
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)
timeFrame: From Baseline to Visit 7 (Month 33)
Secondary outcomes:
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)
timeFrame: From Baseline to Visit 7 (Month 33)
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33)
timeFrame: From Baseline to Visit 7 (Month 33)
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)
timeFrame: 33 months
measure: Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)
timeFrame: 33 months
measure: Hoehn & Yahr Stage at Visit 7 (Month 33)
timeFrame: 33 months
measure: Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months)
timeFrame: 33 months
Other outcomes:
Locations:
city: Chomutov
country: Czechia
facility: 813
city: Hradec Kralove
country: Czechia
facility: 808
city: Hradec Kralove
country: Czechia
facility: 822
city: Litomysl
country: Czechia
facility: 811
city: Ostrava-Poruba
country: Czechia
facility: 803
city: Pardubice
country: Czechia
facility: 809
city: Pisek
country: Czechia
facility: 817
city: Plzen-Lochotin
country: Czechia
facility: 814
city: Praha 10
country: Czechia
facility: 829
city: Praha 1
country: Czechia
facility: 805
city: Praha 4
country: Czechia
facility: 825
city: Praha 5
country: Czechia
facility: 804
city: Rakovnik
country: Czechia
facility: 832
city: Zlin
country: Czechia
facility: 819
city: Aalborg
country: Denmark
facility: 752
city: Aarhus
country: Denmark
facility: 751
city: Sonderborg
country: Denmark
facility: 750
city: Aalen
country: Germany
facility: 242
city: Achim
country: Germany
facility: 143
city: Alzenau
country: Germany
facility: 240
city: Annaberg-Buchholz
country: Germany
facility: 145
city: Aschaffenburg
country: Germany
facility: 245
city: Augsburg
country: Germany
facility: 185
city: Bad Neustadt
country: Germany
facility: 130
city: Bamberg
country: Germany
facility: 131
city: Berg
country: Germany
facility: 103
city: Berlin
country: Germany
facility: 102
city: Berlin
country: Germany
facility: 110
city: Berlin
country: Germany
facility: 113
city: Berlin
country: Germany
facility: 119
city: Berlin
country: Germany
facility: 142
city: Berlin
country: Germany
facility: 150
city: Berlin
country: Germany
facility: 157
city: Berlin
country: Germany
facility: 163
city: Berlin
country: Germany
facility: 166
city: Berlin
country: Germany
facility: 195
city: Berlin
country: Germany
facility: 198
city: Berlin
country: Germany
facility: 206
city: Berlin
country: Germany
facility: 207
city: Berlin
country: Germany
facility: 224
city: Berlin
country: Germany
facility: 243
city: Bielefeld
country: Germany
facility: 108
city: Bielefield
country: Germany
facility: 127
city: Blankenburg (Harz)
country: Germany
facility: 178
city: Bochum
country: Germany
facility: 149
city: Bochum
country: Germany
facility: 151
city: Bochum
country: Germany
facility: 216
city: Brandenburg
country: Germany
facility: 220
city: Butzbach
country: Germany
facility: 236
city: Butzbach
country: Germany
facility: 237
city: Böblingen
country: Germany
facility: 203
city: Dresden
country: Germany
facility: 133
city: Dresden
country: Germany
facility: 199
city: Dresden
country: Germany
facility: 232
city: Duisburg
country: Germany
facility: 219
city: Düsseldorf
country: Germany
facility: 112
city: Düsseldorf
country: Germany
facility: 141
city: Emmendingen
country: Germany
facility: 129
city: Erbach
country: Germany
facility: 162
city: Flensburg
country: Germany
facility: 202
city: Friedberg (Hessen)
country: Germany
facility: 156
city: Gera
country: Germany
facility: 247
city: Greifswald
country: Germany
facility: 223
city: Hagen
country: Germany
facility: 249
city: Halle (Saale)
country: Germany
facility: 167
city: Hamburg
country: Germany
facility: 121
city: Hamburg
country: Germany
facility: 140
city: Hamburg
country: Germany
facility: 176
city: Hamburg
country: Germany
facility: 217
city: Heidenheim
country: Germany
facility: 241
city: Hemmoor
country: Germany
facility: 138
city: Herborn
country: Germany
facility: 173
city: Jena
country: Germany
facility: 214
city: Jena
country: Germany
facility: 248
city: Jülich
country: Germany
facility: 181
city: Karlstadt
country: Germany
facility: 105
city: Karlstadt
country: Germany
facility: 106
city: Kassel
country: Germany
facility: 244
city: Köln
country: Germany
facility: 124
city: Köln
country: Germany
facility: 153
city: Köln
country: Germany
facility: 179
city: Leutkirch
country: Germany
facility: 175
city: Lutherstadt Eisleben
country: Germany
facility: 152
city: Magdeburg
country: Germany
facility: 230
city: Mannheim
country: Germany
facility: 235
city: München
country: Germany
facility: 148
city: München
country: Germany
facility: 189
city: München
country: Germany
facility: 191
city: Naumburg (Saale)
country: Germany
facility: 169
city: Neuburg
country: Germany
facility: 182
city: Oberhausen
country: Germany
facility: 118
city: Oberursel (Taunus)
country: Germany
facility: 164
city: Oldenburg
country: Germany
facility: 171
city: Oranienburg
country: Germany
facility: 196
city: Rheda-Wiedenbrück
country: Germany
facility: 114
city: Rottenburg Am Neckar
country: Germany
facility: 188
city: Schriesheim
country: Germany
facility: 187
city: Schwerin
country: Germany
facility: 107
city: Singen
country: Germany
facility: 134
city: Stadtroda
country: Germany
facility: 229
city: Starnberg
country: Germany
facility: 180
city: Stuttgart
country: Germany
facility: 146
city: Stuttgart
country: Germany
facility: 186
city: Stuttgart
country: Germany
facility: 211
city: Tübingen
country: Germany
facility: 226
city: Ulm
country: Germany
facility: 139
city: Unterhaching
country: Germany
facility: 172
city: Westerstede
country: Germany
facility: 239
city: Wiesbaden
country: Germany
facility: 233
city: Wolfach
country: Germany
facility: 122
city: Zwickau
country: Germany
facility: 194
city: Alexandroupoli
country: Greece
facility: 607
city: Athens
country: Greece
facility: 600
city: Athens
country: Greece
facility: 602
city: Athens
country: Greece
facility: 605
city: Athens
country: Greece
facility: 610
city: Chaidari
country: Greece
facility: 608
city: Marousi
country: Greece
facility: 611
city: Melissia
country: Greece
facility: 601
city: Thessaloniki
country: Greece
facility: 604
city: Thessaloniki
country: Greece
facility: 606
city: Acquaviva Delle Fonti
country: Italy
facility: 664
city: Ancona
country: Italy
facility: 654
city: Bari
country: Italy
facility: 665
city: Cagliari
country: Italy
facility: 655
city: Casarano
country: Italy
facility: 666
city: Cassino
country: Italy
facility: 662
city: Ferrara
country: Italy
facility: 653
city: Imperia
country: Italy
facility: 661
city: Lido Di Camaiore
country: Italy
facility: 650
city: Lodi
country: Italy
facility: 663
city: Messina
country: Italy
facility: 658
city: Napoli
country: Italy
facility: 660
city: Pisa
country: Italy
facility: 667
city: Roma
country: Italy
facility: 657
city: San Giovannni Rotondo
country: Italy
facility: 656
city: Torino
country: Italy
facility: 669
city: Aguascalientes
country: Mexico
facility: 704
city: Guadalajara
country: Mexico
facility: 707
city: Merida
country: Mexico
facility: 703
city: Mexico D.F.
country: Mexico
facility: 701
city: Mexico D.F.
country: Mexico
facility: 702
city: Monterrey
country: Mexico
facility: 706
city: Morelia Michoacan
country: Mexico
facility: 710
city: San Luis Potosi
country: Mexico
facility: 708
city: Zapopan
country: Mexico
facility: 705
city: Arad
country: Romania
facility: 425
city: Bacau
country: Romania
facility: 406
city: Bacau
country: Romania
facility: 407
city: Bistrita
country: Romania
facility: 417
city: Bucharest
country: Romania
facility: 412
city: Bucharest
country: Romania
facility: 418
city: Bucharest
country: Romania
facility: 423
city: Bucharest
country: Romania
facility: 424
city: Bucharest
country: Romania
facility: 434
city: Bucharest
country: Romania
facility: 436
city: Constanta
country: Romania
facility: 427
city: Craiova
country: Romania
facility: 411
city: Craiova
country: Romania
facility: 433
city: Drobeta Turnu Severin
country: Romania
facility: 404
city: Foscani, Jud. Vrancea
country: Romania
facility: 437
city: Galati
country: Romania
facility: 405
city: Galati
country: Romania
facility: 420
city: Lasi
country: Romania
facility: 403
city: Lasi
country: Romania
facility: 409
city: Medgidia
country: Romania
facility: 415
city: Orastie
country: Romania
facility: 402
city: Pitesti
country: Romania
facility: 401
city: Pitesti
country: Romania
facility: 428
city: Resista
country: Romania
facility: 422
city: Râmnicu Vâlcea
country: Romania
facility: 435
city: Satu Mare
country: Romania
facility: 408
city: Sfantu Gheorghe
country: Romania
facility: 429
city: Sibiu
country: Romania
facility: 413
city: Targoviste
country: Romania
facility: 416
city: Timisoara
country: Romania
facility: 414
city: Timisoara
country: Romania
facility: 421
city: Târgu-Mureş
country: Romania
facility: 432
city: Banska Bystrica
country: Slovakia
facility: 521
city: Bratislava
country: Slovakia
facility: 500
city: Bratislava
country: Slovakia
facility: 502
city: Bratislava
country: Slovakia
facility: 507
city: Bratislava
country: Slovakia
facility: 514
city: Dolni Kubin
country: Slovakia
facility: 501
city: Dubnica Nad Vahom
country: Slovakia
facility: 505
city: Krompachy
country: Slovakia
facility: 522
city: Lucenec
country: Slovakia
facility: 520
city: Skalica
country: Slovakia
facility: 508
city: Spisska Nova Ves
country: Slovakia
facility: 503
city: Stara Lubovna
country: Slovakia
facility: 509
city: Trencin
country: Slovakia
facility: 510
city: Vranov
country: Slovakia
facility: 519
city: Zilina
country: Slovakia
facility: 516
city: Zvolen
country: Slovakia
facility: 518
city: Alzira (Valencia)
country: Spain
facility: 308
city: Badalona
country: Spain
facility: 320
city: Barcelona
country: Spain
facility: 301
city: Barcelona
country: Spain
facility: 303
city: Barcelona
country: Spain
facility: 305
city: Barcelona
country: Spain
facility: 318
city: Burgos
country: Spain
facility: 315
city: Ciudad Real
country: Spain
facility: 313
city: Madrid
country: Spain
facility: 306
city: Madrid
country: Spain
facility: 307
city: Palma de Mallorca
country: Spain
facility: 314
city: Valencia
country: Spain
facility: 312
city: Biel
country: Switzerland
facility: 355
city: Sargans
country: Switzerland
facility: 353
city: St. Gallen
country: Switzerland
facility: 354
city: Tschugg
country: Switzerland
facility: 351
city: Zürich
country: Switzerland
facility: 350
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.