Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice

June 6, 2014 updated by: Boehringer Ingelheim
The general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinson's disease in routine clinical practice.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1814

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Bad Ischl, Austria
        • Boehringer Ingelheim Investigational Site 1
      • Bad Radkersburg, Austria
        • Boehringer Ingelheim Investigational Site 2
      • Baden, Austria
        • Boehringer Ingelheim Investigational Site 3
      • Baden, Austria
        • Boehringer Ingelheim Investigational Site 4
      • Bludenz, Austria
        • Boehringer Ingelheim Investigational Site 5
      • Braunau/Inn, Austria
        • Boehringer Ingelheim Investigational Site 6
      • Deutschlandsberg, Austria
        • Boehringer Ingelheim Investigational Site 7
      • Dornbirn, Austria
        • Boehringer Ingelheim Investigational Site 8
      • Dornbirn, Austria
        • Boehringer Ingelheim Investigational Site 9
      • Ehenbichl, Austria
        • Boehringer Ingelheim Investigational Site 10
      • Eisenstadt, Austria
        • Boehringer Ingelheim Investigational Site 11
      • Eisenstadt, Austria
        • Boehringer Ingelheim Investigational Site 12
      • Feldbach, Austria
        • Boehringer Ingelheim Investigational Site 13
      • Feldkirchen, Austria
        • Boehringer Ingelheim Investigational Site 14
      • Graz, Austria
        • Boehringer Ingelheim Investigational Site 16
      • Graz, Austria
        • Boehringer Ingelheim Investigational Site 17
      • Graz, Austria
        • Boehringer Ingelheim Investigational Site 18
      • Graz, Austria
        • Boehringer Ingelheim Investigational Site 19
      • Grieskirchen, Austria
        • Boehringer Ingelheim Investigational Site 20
      • Grimmenstein, Austria
        • Boehringer Ingelheim Investigational Site 21
      • Gänserndorf, Austria
        • Boehringer Ingelheim Investigational Site 15
      • Hainburg, Austria
        • Boehringer Ingelheim Investigational Site 22
      • Hall/Tirol, Austria
        • Boehringer Ingelheim Investigational Site 23
      • Hallein, Austria
        • Boehringer Ingelheim Investigational Site 24
      • Hartberg, Austria
        • Boehringer Ingelheim Investigational Site 25
      • Hermagor, Austria
        • Boehringer Ingelheim Investigational Site 26
      • Hohenems, Austria
        • Boehringer Ingelheim Investigational Site 27
      • Horn, Austria
        • Boehringer Ingelheim Investigational Site 28
      • Horn, Austria
        • Boehringer Ingelheim Investigational Site 29
      • Imst, Austria
        • Boehringer Ingelheim Investigational Site 30
      • Innsbruck, Austria
        • Boehringer Ingelheim Investigational Site 31
      • Innsbruck, Austria
        • Boehringer Ingelheim Investigational Site 32
      • Innsbruck, Austria
        • Boehringer Ingelheim Investigational Site 33
      • Judenburg, Austria
        • Boehringer Ingelheim Investigational Site 34
      • Kapfenberg, Austria
        • Boehringer Ingelheim Investigational Site 35
      • Klagenfurt, Austria
        • Boehringer Ingelheim Investigational Site 36
      • Klagenfurt, Austria
        • Boehringer Ingelheim Investigational Site 37
      • Klagenfurt, Austria
        • Boehringer Ingelheim Investigational Site 38
      • Klagenfurt, Austria
        • Boehringer Ingelheim Investigational Site 39
      • Knittelfeld, Austria
        • Boehringer Ingelheim Investigational Site 40
      • Krems, Austria
        • Boehringer Ingelheim Investigational Site 41
      • Kufstein, Austria
        • Boehringer Ingelheim Investigational Site 42
      • Laßnitzhöhe, Austria
        • Boehringer Ingelheim Investigational Site 43
      • Leibnitz, Austria
        • Boehringer Ingelheim Investigational Site 44
      • Leoben, Austria
        • Boehringer Ingelheim Investigational Site 45
      • Lienz, Austria
        • Boehringer Ingelheim Investigational Site 46
      • Lienz, Austria
        • Boehringer Ingelheim Investigational Site 47
      • Lilienfeld, Austria
        • Boehringer Ingelheim Investigational Site 48
      • Linz, Austria
        • Boehringer Ingelheim Investigational Site 49
      • Linz, Austria
        • Boehringer Ingelheim Investigational Site 50
      • Melk, Austria
        • Boehringer Ingelheim Investigational Site 51
      • Mürzzuschlag, Austria
        • Boehringer Ingelheim Investigational Site 52
      • Neulengbach, Austria
        • Boehringer Ingelheim Investigational Site 53
      • Neulengbach, Austria
        • Boehringer Ingelheim Investigational Site 54
      • Neunkirchen, Austria
        • Boehringer Ingelheim Investigational Site 55
      • Neunkirchen, Austria
        • Boehringer Ingelheim Investigational Site 56
      • Neusiedl am See, Austria
        • Boehringer Ingelheim Investigational Site 57
      • Oberwart, Austria
        • Boehringer Ingelheim Investigational Site 58
      • Oberwart, Austria
        • Boehringer Ingelheim Investigational Site 59
      • Oberwart, Austria
        • Boehringer Ingelheim Investigational Site 60
      • Regelsbrunn, Austria
        • Boehringer Ingelheim Investigational Site 61
      • Ried im Innkreis, Austria
        • Boehringer Ingelheim Investigational Site 62
      • Ried im Innkreis, Austria
        • Boehringer Ingelheim Investigational Site 63
      • Rohrbach, Austria
        • Boehringer Ingelheim Investigational Site 64
      • Salzburg, Austria
        • Boehringer Ingelheim Investigational Site 65
      • Salzburg, Austria
        • Boehringer Ingelheim Investigational Site 66
      • Salzburg, Austria
        • Boehringer Ingelheim Investigational Site 67
      • Salzburg, Austria
        • Boehringer Ingelheim Investigational Site 68
      • Scheibbs, Austria
        • Boehringer Ingelheim Investigational Site 69
      • St. Johann im Pongau, Austria
        • Boehringer Ingelheim Investigational Site 70
      • St. Pölten, Austria
        • Boehringer Ingelheim Investigational Site 71
      • St. Pölten, Austria
        • Boehringer Ingelheim Investigational Site 72
      • St. Veit an der Glan, Austria
        • Boehringer Ingelheim Investigational Site 73
      • Telfs, Austria
        • Boehringer Ingelheim Investigational Site 74
      • Tulln, Austria
        • Boehringer Ingelheim Investigational Site 75
      • Tullnerbach-Lawies, Austria
        • Boehringer Ingelheim Investigational Site 76
      • Villach, Austria
        • Boehringer Ingelheim Investigational Site 77
      • Villach, Austria
        • Boehringer Ingelheim Investigational Site 78
      • Villach-Warmbad, Austria
        • Boehringer Ingelheim Investigational Site 79
      • Vöcklabruck, Austria
        • Boehringer Ingelheim Investigational Site 80
      • Vöcklabruck, Austria
        • Boehringer Ingelheim Investigational Site 81
      • Völkermarkt, Austria
        • Boehringer Ingelheim Investigational Site 82
      • Wagna, Austria
        • Boehringer Ingelheim Investigational Site 83
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 100
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 101
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 102
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 103
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 104
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 105
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 106
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 107
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 84
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 85
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 86
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 87
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 88
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 89
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 90
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 91
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 92
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 93
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 94
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 95
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 96
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 97
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 98
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site 99
      • Wiener Neustadt, Austria
        • Boehringer Ingelheim Investigational Site 108
      • Wolfsberg, Austria
        • Boehringer Ingelheim Investigational Site 109
      • Zirl, Austria
        • Boehringer Ingelheim Investigational Site 110
      • Zwettl, Austria
        • Boehringer Ingelheim Investigational Site 111
  • Estonia
      • Järvamaa, Estonia
        • Boehringer Ingelheim Investigational Site 115
      • Kohtla-Järve, Estonia
        • Boehringer Ingelheim Investigational Site 114
      • Kuressaare, Estonia
        • Boehringer Ingelheim Investigational Site 121
      • Rakvere, Estonia
        • Boehringer Ingelheim Investigational Site 116
      • Tallinn, Estonia
        • Boehringer Ingelheim Investigational Site 112
      • Tallinn, Estonia
        • Boehringer Ingelheim Investigational Site 113
      • Tartu, Estonia
        • Boehringer Ingelheim Investigational Site 117
      • Valga, Estonia
        • Boehringer Ingelheim Investigational Site 118
      • Viimsi, Estonia
        • Boehringer Ingelheim Investigational Site 119
      • Viljandi, Estonia
        • Boehringer Ingelheim Investigational Site 120
  • Kazakhstan
      • Almaty, Kazakhstan
        • Boehringer Ingelheim Investigational Site 283
      • Astana, Kazakhstan
        • Boehringer Ingelheim Investigational Site 284
      • Shymkent, Kazakhstan
        • Boehringer Ingelheim Investigational Site 282
  • Romania
      • Alba Iulia, Romania
        • Boehringer Ingelheim Investigational Site 193
      • Bacau, Romania
        • Boehringer Ingelheim Investigational Site 194
      • Bacau, Romania
        • Boehringer Ingelheim Investigational Site 195
      • Bacau, Romania
        • Boehringer Ingelheim Investigational Site 196
      • Baia Mare, Romania
        • Boehringer Ingelheim Investigational Site 197
      • Baia Mare, Romania
        • Boehringer Ingelheim Investigational Site 198
      • Botosani, Romania
        • Boehringer Ingelheim Investigational Site 199
      • Brasov, Romania
        • Boehringer Ingelheim Investigational Site 200
      • Brasov, Romania
        • Boehringer Ingelheim Investigational Site 201
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 202
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 203
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 204
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 205
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 206
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 207
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 208
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 209
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 210
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 211
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 212
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 213
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 214
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 215
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 216
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 217
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 218
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 219
      • Buzau, Romania
        • Boehringer Ingelheim Investigational Site 220
      • Buzau, Romania
        • Boehringer Ingelheim Investigational Site 221
      • Campulung, Romania
        • Boehringer Ingelheim Investigational Site 222
      • Cluj-Napoca, Romania
        • Boehringer Ingelheim Investigational Site 223
      • Cluj-Napoca, Romania
        • Boehringer Ingelheim Investigational Site 224
      • Constanta, Romania
        • Boehringer Ingelheim Investigational Site 225
      • Constanta, Romania
        • Boehringer Ingelheim Investigational Site 226
      • Constanta, Romania
        • Boehringer Ingelheim Investigational Site 227
      • Craiova, Romania
        • Boehringer Ingelheim Investigational Site 228
      • Craiova, Romania
        • Boehringer Ingelheim Investigational Site 229
      • Craiova, Romania
        • Boehringer Ingelheim Investigational Site 230
      • Craiova, Romania
        • Boehringer Ingelheim Investigational Site 231
      • Craiova, Romania
        • Boehringer Ingelheim Investigational Site 232
      • Curtea de Arges, Romania
        • Boehringer Ingelheim Investigational Site 233
      • Focsani, Romania
        • Boehringer Ingelheim Investigational Site 234
      • Focsani, Romania
        • Boehringer Ingelheim Investigational Site 235
      • Galati, Romania
        • Boehringer Ingelheim Investigational Site 236
      • Iasi, Romania
        • Boehringer Ingelheim Investigational Site 237
      • Iasi, Romania
        • Boehringer Ingelheim Investigational Site 238
      • Iasi, Romania
        • Boehringer Ingelheim Investigational Site 239
      • Medgidia, Romania
        • Boehringer Ingelheim Investigational Site 240
      • Oradea, Romania
        • Boehringer Ingelheim Investigational Site 241
      • Oradea, Romania
        • Boehringer Ingelheim Investigational Site 242
      • Piatra Neamt, Romania
        • Boehringer Ingelheim Investigational Site 243
      • Piatra Neamt, Romania
        • Boehringer Ingelheim Investigational Site 244
      • Pitesti, Romania
        • Boehringer Ingelheim Investigational Site 245
      • Pitesti, Romania
        • Boehringer Ingelheim Investigational Site 246
      • Ploiesti, Romania
        • Boehringer Ingelheim Investigational Site 247
      • Prahova, Romania
        • Boehringer Ingelheim Investigational Site 248
      • Radauti, Romania
        • Boehringer Ingelheim Investigational Site 249
      • Ramnicu Valcea, Romania
        • Boehringer Ingelheim Investigational Site 250
      • Ramnicu Valcea, Romania
        • Boehringer Ingelheim Investigational Site 251
      • Ramnicu Valcea, Romania
        • Boehringer Ingelheim Investigational Site 252
      • Satu Mare, Romania
        • Boehringer Ingelheim Investigational Site 253
      • Satu Mare, Romania
        • Boehringer Ingelheim Investigational Site 254
      • Sibiu, Romania
        • Boehringer Ingelheim Investigational Site 255
      • Sibiu, Romania
        • Boehringer Ingelheim Investigational Site 256
      • Simleul Silvaniei, Romania
        • Boehringer Ingelheim Investigational Site 257
      • Slobozia, Romania
        • Boehringer Ingelheim Investigational Site 258
      • Suceava, Romania
        • Boehringer Ingelheim Investigational Site 259
      • Targoviste, Romania
        • Boehringer Ingelheim Investigational Site 260
      • Targoviste, Romania
        • Boehringer Ingelheim Investigational Site 261
      • Targu Mures, Romania
        • Boehringer Ingelheim Investigational Site 262
      • Tarnaveni, Romania
        • Boehringer Ingelheim Investigational Site 263
      • Tarnaveni, Romania
        • Boehringer Ingelheim Investigational Site 264
      • Timisoara, Romania
        • Boehringer Ingelheim Investigational Site 265
      • Timisoara, Romania
        • Boehringer Ingelheim Investigational Site 266
      • Timisoara, Romania
        • Boehringer Ingelheim Investigational Site 267
      • Timisoara, Romania
        • Boehringer Ingelheim Investigational Site 268
      • Tulcea, Romania
        • Boehringer Ingelheim Investigational Site 269
      • Tulcea, Romania
        • Boehringer Ingelheim Investigational Site 270
      • Tulcea, Romania
        • Boehringer Ingelheim Investigational Site 271
      • Turda, Romania
        • Boehringer Ingelheim Investigational Site 272
      • Turnu Magurele, Romania
        • Boehringer Ingelheim Investigational Site 273
      • Zalau, Romania
        • Boehringer Ingelheim Investigational Site 274
  • Serbia
      • Belgrade, Serbia
        • Boehringer Ingelheim Investigational Site 275
      • Belgrade, Serbia
        • Boehringer Ingelheim Investigational Site 276
      • Kragujevac, Serbia
        • Boehringer Ingelheim Investigational Site 278
      • Kraljevo, Serbia
        • Boehringer Ingelheim Investigational Site 281
      • Nis, Serbia
        • Boehringer Ingelheim Investigational Site 279
      • Novi Sad, Serbia
        • Boehringer Ingelheim Investigational Site 277
      • Uzice, Serbia
        • Boehringer Ingelheim Investigational Site 280
  • Slovakia
      • Banská Bystrica, Slovakia
        • Boehringer Ingelheim Investigational Site 122
      • Bardejov, Slovakia
        • Boehringer Ingelheim Investigational Site 123
      • Bardejov, Slovakia
        • Boehringer Ingelheim Investigational Site 124
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 125
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 126
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 127
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 128
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 129
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 130
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 131
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 132
      • Brezno, Slovakia
        • Boehringer Ingelheim Investigational Site 133
      • Detva, Slovakia
        • Boehringer Ingelheim Investigational Site 134
      • Dolný Kubín, Slovakia
        • Boehringer Ingelheim Investigational Site 135
      • Dolný Kubín, Slovakia
        • Boehringer Ingelheim Investigational Site 136
      • Hlohovec, Slovakia
        • Boehringer Ingelheim Investigational Site 137
      • Hlohovec, Slovakia
        • Boehringer Ingelheim Investigational Site 138
      • Humenné, Slovakia
        • Boehringer Ingelheim Investigational Site 139
      • Kezmarok, Slovakia
        • Boehringer Ingelheim Investigational Site 140
      • Kezmarok, Slovakia
        • Boehringer Ingelheim Investigational Site 141
      • Komárno, Slovakia
        • Boehringer Ingelheim Investigational Site 142
      • Kosice, Slovakia
        • Boehringer Ingelheim Investigational Site 143
      • Kosice, Slovakia
        • Boehringer Ingelheim Investigational Site 144
      • Kosice, Slovakia
        • Boehringer Ingelheim Investigational Site 145
      • Kosice, Slovakia
        • Boehringer Ingelheim Investigational Site 146
      • Kosice, Slovakia
        • Boehringer Ingelheim Investigational Site 147
      • Krompachy, Slovakia
        • Boehringer Ingelheim Investigational Site 148
      • Liptovský Mikulás, Slovakia
        • Boehringer Ingelheim Investigational Site 149
      • Lucenec, Slovakia
        • Boehringer Ingelheim Investigational Site 150
      • Lucenec, Slovakia
        • Boehringer Ingelheim Investigational Site 151
      • Lucenec, Slovakia
        • Boehringer Ingelheim Investigational Site 152
      • Martin, Slovakia
        • Boehringer Ingelheim Investigational Site 153
      • Martin, Slovakia
        • Boehringer Ingelheim Investigational Site 154
      • Myjava, Slovakia
        • Boehringer Ingelheim Investigational Site 155
      • Nitra, Slovakia
        • Boehringer Ingelheim Investigational Site 157
      • Nitra, Slovakia
        • Boehringer Ingelheim Investigational Site 158
      • Nitra, Slovakia
        • Boehringer Ingelheim Investigational Site 159
      • Nitra, Slovakia
        • Boehringer Ingelheim Investigational Site 160
      • Námestovo, Slovakia
        • Boehringer Ingelheim Investigational Site 156
      • Pezinok, Slovakia
        • Boehringer Ingelheim Investigational Site 161
      • Piestany, Slovakia
        • Boehringer Ingelheim Investigational Site 162
      • Presov, Slovakia
        • Boehringer Ingelheim Investigational Site 163
      • Presov, Slovakia
        • Boehringer Ingelheim Investigational Site 164
      • Presov, Slovakia
        • Boehringer Ingelheim Investigational Site 165
      • Presov, Slovakia
        • Boehringer Ingelheim Investigational Site 166
      • Sahy, Slovakia
        • Boehringer Ingelheim Investigational Site 167
      • Sala, Slovakia
        • Boehringer Ingelheim Investigational Site 168
      • Skalica, Slovakia
        • Boehringer Ingelheim Investigational Site 169
      • Stará Lubovna, Slovakia
        • Boehringer Ingelheim Investigational Site 170
      • Surany, Slovakia
        • Boehringer Ingelheim Investigational Site 171
      • Topolcany, Slovakia
        • Boehringer Ingelheim Investigational Site 172
      • Trebisov, Slovakia
        • Boehringer Ingelheim Investigational Site 173
      • Trencín, Slovakia
        • Boehringer Ingelheim Investigational Site 174
      • Trnava, Slovakia
        • Boehringer Ingelheim Investigational Site 175
      • Trnava, Slovakia
        • Boehringer Ingelheim Investigational Site 176
      • Trstená, Slovakia
        • Boehringer Ingelheim Investigational Site 177
      • Vranov nad Top?ou, Slovakia
        • Boehringer Ingelheim Investigational Site 178
      • Ziar nad Hronom, Slovakia
        • Boehringer Ingelheim Investigational Site 179
      • Zilina, Slovakia
        • Boehringer Ingelheim Investigational Site 180
      • Zlaté Moravce, Slovakia
        • Boehringer Ingelheim Investigational Site 182
      • Zvolen, Slovakia
        • Boehringer Ingelheim Investigational Site 181
  • Slovenia
      • Celje, Slovenia
        • Boehringer Ingelheim Investigational Site 183
      • Lesce, Slovenia
        • Boehringer Ingelheim Investigational Site 184
      • Ljubljana, Slovenia
        • Boehringer Ingelheim Investigational Site 185
      • Ljubljana, Slovenia
        • Boehringer Ingelheim Investigational Site 186
      • Maribor, Slovenia
        • Boehringer Ingelheim Investigational Site 187
      • Maribor, Slovenia
        • Boehringer Ingelheim Investigational Site 188
      • Sempeter, Slovenia
        • Boehringer Ingelheim Investigational Site 190
      • Sempeter, Slovenia
        • Boehringer Ingelheim Investigational Site 191
      • Slovenj Gradec, Slovenia
        • Boehringer Ingelheim Investigational Site 189
      • Velenje, Slovenia
        • Boehringer Ingelheim Investigational Site 192

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients

Description

Inclusion criteria:

  • Early and advanced idiopathic Parkinson's disease
  • Male and female patients over 18 years of age
  • Indication for treatment with pramipexole ER according to Summary of Product Characteristics (SmPC)

Exclusion criteria:

  • Ongoing treatment with pramipexole ER
  • Exclusion criteria in line with the pramipexole ER SmPC:

In particular hypersensitivity to pramipexole or to any of the excipients and pregnancy and lactation as stated in the SmPC.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Male and female patients with Parkinson's disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: From the treatment initiation to the end of study, on average 92.9 days
The number of patients with any adverse events (AEs), patients with drug-related AEs.
From the treatment initiation to the end of study, on average 92.9 days
Proportion of Patients With Withdrawals Due to Adverse Events.
Time Frame: 16 weeks
Patients who discontinued treatment due to adverse events including deaths.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score
Time Frame: Baseline and the end of study (up to 16 weeks)
Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change>0) in the score means improvement.
Baseline and the end of study (up to 16 weeks)
Clinical Global Impression of Improvement (CGI-I) Responder Rate
Time Frame: Baseline and the end of study (up to 16 weeks)
The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson's disease. The clinician rated how much a patient's condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved.
Baseline and the end of study (up to 16 weeks)
Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction
Time Frame: Baseline and the end of study (up to 16 weeks)
The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change>0) reflects an improvement in patient satisfaction.
Baseline and the end of study (up to 16 weeks)
Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score
Time Frame: Baseline and the end of study (up to 16 weeks)
The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change >0 reflects an improvement
Baseline and the end of study (up to 16 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 24, 2009

First Submitted That Met QC Criteria

February 2, 2010

First Posted (Estimate)

February 3, 2010

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

June 6, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.675

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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