Transdermal Rotigotine User Surveillance Study

NCT ID: NCT00599339

Last Updated: 2018-08-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2014-04-30

Brief Summary

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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

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

Conditions

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Idiopathic Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neupro

Neupro at study onset

No interventions assigned to this group

Dopamine Agonist

Other Dopamine-Agonist at study onset

No interventions assigned to this group

L-Dopa

L-Dopa

No interventions assigned to this group

Neupro + L-Dopa

Neupro in combination with L-Dopa at study onset

No interventions assigned to this group

Dopamine Agonist + L-Dopa

Other Dopamine Agonist in combination with L-Dopa at study onset

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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813

Chomutov, , Czechia

Site Status

808

Hradec Králové, , Czechia

Site Status

822

Hradec Králové, , Czechia

Site Status

811

Litomyšl, , Czechia

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803

Ostrava-Poruba, , Czechia

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809

Pardubice, , Czechia

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817

Písek, , Czechia

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814

Plzen-Lochotin, , Czechia

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804

Prague, , Czechia

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805

Prague, , Czechia

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825

Prague, , Czechia

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829

Prague, , Czechia

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832

Rakovník, , Czechia

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819

Zlín, , Czechia

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752

Aalborg, , Denmark

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751

Aarhus, , Denmark

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750

Sønderborg, , Denmark

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242

Aalen, , Germany

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143

Achim, , Germany

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240

Alzenau in Unterfranken, , Germany

Site Status

145

Annaberg-Buchholz, , Germany

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245

Aschaffenburg, , Germany

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185

Augsburg, , Germany

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130

Bad Neustadt an der Saale, , Germany

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131

Bamberg, , Germany

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103

Berg, , Germany

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102

Berlin, , Germany

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110

Berlin, , Germany

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113

Berlin, , Germany

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119

Berlin, , Germany

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142

Berlin, , Germany

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150

Berlin, , Germany

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157

Berlin, , Germany

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163

Berlin, , Germany

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166

Berlin, , Germany

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195

Berlin, , Germany

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198

Berlin, , Germany

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206

Berlin, , Germany

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207

Berlin, , Germany

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224

Berlin, , Germany

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243

Berlin, , Germany

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108

Bielefeld, , Germany

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127

Bielefield, , Germany

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178

Blankenburg (Harz), , Germany

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149

Bochum, , Germany

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151

Bochum, , Germany

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216

Bochum, , Germany

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203

Böblingen, , Germany

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220

Brandenburg, , Germany

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236

Butzbach, , Germany

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237

Butzbach, , Germany

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124

Cologne, , Germany

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153

Cologne, , Germany

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179

Cologne, , Germany

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133

Dresden, , Germany

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199

Dresden, , Germany

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232

Dresden, , Germany

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219

Duisburg, , Germany

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112

Düsseldorf, , Germany

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141

Düsseldorf, , Germany

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152

Eisleben Lutherstadt, , Germany

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129

Emmendingen, , Germany

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162

Erbach im Odenwald, , Germany

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202

Flensburg, , Germany

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156

Friedberg (Hessen), , Germany

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247

Gera, , Germany

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223

Greifswald, , Germany

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249

Hagen, , Germany

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167

Halle, , Germany

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121

Hamburg, , Germany

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140

Hamburg, , Germany

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176

Hamburg, , Germany

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217

Hamburg, , Germany

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241

Heidenheim, , Germany

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138

Hemmoor, , Germany

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173

Herborn, , Germany

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214

Jena, , Germany

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248

Jena, , Germany

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181

Jülich, , Germany

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105

Karlstadt am Main, , Germany

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106

Karlstadt am Main, , Germany

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244

Kassel, , Germany

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175

Leutkirch, , Germany

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230

Magdeburg, , Germany

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235

Mannheim, , Germany

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148

München, , Germany

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189

München, , Germany

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191

München, , Germany

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169

Naumburg, , Germany

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182

Neuburg am Inn, , Germany

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118

Oberhausen, , Germany

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164

Oberursel (Taunus), , Germany

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171

Oldenburg, , Germany

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196

Oranienburg, , Germany

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114

Rheda-Wiedenbrück, , Germany

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188

Rottenburg Am Neckar, , Germany

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187

Schriesheim, , Germany

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107

Schwerin, , Germany

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134

Singen, , Germany

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229

Stadtroda, , Germany

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180

Starnberg, , Germany

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146

Stuttgart, , Germany

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186

Stuttgart, , Germany

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211

Stuttgart, , Germany

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226

Tübingen, , Germany

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139

Ulm, , Germany

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172

Unterhaching, , Germany

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239

Westerstede, , Germany

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233

Wiesbaden, , Germany

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122

Wolfach, , Germany

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194

Zwickau, , Germany

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607

Alexandroupoli, , Greece

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600

Athens, , Greece

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602

Athens, , Greece

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605

Athens, , Greece

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610

Athens, , Greece

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608

Chaïdári, , Greece

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611

Marousi, , Greece

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601

Melíssia, , Greece

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604

Thessaloniki, , Greece

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606

Thessaloniki, , Greece

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664

Acquaviva delle Fonti, , Italy

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654

Ancona, , Italy

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665

Bari, , Italy

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655

Cagliari, , Italy

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666

Casarano, , Italy

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662

Cassino, , Italy

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653

Ferrara, , Italy

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661

Imperia, , Italy

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650

Lido di Camaiore, , Italy

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663

Lodi, , Italy

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658

Messina, , Italy

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660

Napoli, , Italy

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667

Pisa, , Italy

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657

Roma, , Italy

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656

San Giovannni Rotondo, , Italy

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669

Torino, , Italy

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704

Aguascalientes, , Mexico

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707

Guadalajara, , Mexico

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701

Mexico City, , Mexico

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702

Mexico City, , Mexico

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703

Mérida, , Mexico

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706

Monterrey, , Mexico

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710

Morelia Michoacan, , Mexico

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708

San Luis Potosí City, , Mexico

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705

Zapopan, , Mexico

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425

Arad, , Romania

Site Status

406

Bacau, , Romania

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407

Bacau, , Romania

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417

Bistriţa, , Romania

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412

Bucharest, , Romania

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418

Bucharest, , Romania

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423

Bucharest, , Romania

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424

Bucharest, , Romania

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434

Bucharest, , Romania

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436

Bucharest, , Romania

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427

Constanța, , Romania

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411

Craiova, , Romania

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433

Craiova, , Romania

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404

Drobeta-Turnu Severin, , Romania

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437

Foscani, Jud. Vrancea, , Romania

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405

Galati, , Romania

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420

Galati, , Romania

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403

Lasi, , Romania

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409

Lasi, , Romania

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415

Medgidia, , Romania

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402

Orăştie, , Romania

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401

Piteşti, , Romania

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428

Piteşti, , Romania

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435

Râmnicu Vâlcea, , Romania

Site Status

422

Resista, , Romania

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408

Satu Mare, , Romania

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429

Sfântu Gheorghe, , Romania

Site Status

413

Sibiu, , Romania

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416

Târgovişte, , Romania

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432

Târgu Mureş, , Romania

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414

Timișoara, , Romania

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421

Timișoara, , Romania

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521

Banská Bystrica, , Slovakia

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500

Bratislava, , Slovakia

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502

Bratislava, , Slovakia

Site Status

507

Bratislava, , Slovakia

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514

Bratislava, , Slovakia

Site Status

501

Dolný Kubín, , Slovakia

Site Status

505

Dubnica nad Váhom, , Slovakia

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522

Krompachy, , Slovakia

Site Status

520

Lučenec, , Slovakia

Site Status

508

Skalica, , Slovakia

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503

Spišská Nová Ves, , Slovakia

Site Status

509

Stará Ľubovňa, , Slovakia

Site Status

510

Trenčín, , Slovakia

Site Status

519

Vranov nad Topľou, , Slovakia

Site Status

518

Zvolen, , Slovakia

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516

Žilina, , Slovakia

Site Status

308

Alzira (Valencia), , Spain

Site Status

320

Badalona, , Spain

Site Status

301

Barcelona, , Spain

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303

Barcelona, , Spain

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305

Barcelona, , Spain

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318

Barcelona, , Spain

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315

Burgos, , Spain

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313

Ciudad Real, , Spain

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306

Madrid, , Spain

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307

Madrid, , Spain

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314

Palma de Mallorca, , Spain

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312

Valencia, , Spain

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355

Biel, , Switzerland

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354

Sankt Gallen, , Switzerland

Site Status

353

Sargans, , Switzerland

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351

Tschugg, , Switzerland

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350

Zurich, , Switzerland

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Countries

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Czechia Denmark Germany Greece Italy Mexico Romania Slovakia Spain Switzerland

References

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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.

Reference Type RESULT
PMID: 29484495 (View on PubMed)

Related Links

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Other Identifiers

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SP0854

Identifier Type: -

Identifier Source: org_study_id

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