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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.
Not provided
Not provided
Not provided
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Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male and female patients with Parkinson's disease |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | 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. | Patients who discontinued treatment due to adverse events including deaths. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score | 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. |
Not provided
Inclusion criteria:
Exclusion criteria:
In particular hypersensitivity to pramipexole or to any of the excipients and pregnancy and lactation as stated in the SmPC.
Not provided
Not provided
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Patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site 1 | Bad Ischl | Austria | ||||
| Boehringer Ingelheim Investigational Site 2 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | Patients with Parkinson's disease in routine clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Baseline and the end of study (up to 16 weeks) |
| Clinical Global Impression of Improvement (CGI-I) Responder Rate | 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 | 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 | 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) |
| Bad Radkersburg |
| Austria |
| Boehringer Ingelheim Investigational Site 3 | Baden | Austria |
| Boehringer Ingelheim Investigational Site 4 | Baden | Austria |
| Boehringer Ingelheim Investigational Site 5 | Bludenz | Austria |
| Boehringer Ingelheim Investigational Site 6 | Braunau/Inn | Austria |
| Boehringer Ingelheim Investigational Site 7 | Deutschlandsberg | Austria |
| Boehringer Ingelheim Investigational Site 8 | Dornbirn | Austria |
| Boehringer Ingelheim Investigational Site 9 | Dornbirn | Austria |
| Boehringer Ingelheim Investigational Site 10 | Ehenbichl | Austria |
| Boehringer Ingelheim Investigational Site 11 | Eisenstadt | Austria |
| Boehringer Ingelheim Investigational Site 12 | Eisenstadt | Austria |
| Boehringer Ingelheim Investigational Site 13 | Feldbach | Austria |
| Boehringer Ingelheim Investigational Site 14 | Feldkirchen in Kärnten | Austria |
| Boehringer Ingelheim Investigational Site 15 | Gänserndorf | 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 | Graz | Austria |
| Boehringer Ingelheim Investigational Site 20 | Grieskirchen | Austria |
| Boehringer Ingelheim Investigational Site 21 | Grimmenstein | Austria |
| Boehringer Ingelheim Investigational Site 22 | Hainburg an der Donau | Austria |
| Boehringer Ingelheim Investigational Site 23 | Hall/Tirol | Austria |
| Boehringer Ingelheim Investigational Site 24 | Hallein | Austria |
| Boehringer Ingelheim Investigational Site 25 | Hartberg | Austria |
| Boehringer Ingelheim Investigational Site 26 | Hermagor | Austria |
| Boehringer Ingelheim Investigational Site 27 | Hohenems | Austria |
| Boehringer Ingelheim Investigational Site 28 | Horn | Austria |
| Boehringer Ingelheim Investigational Site 29 | Horn | Austria |
| Boehringer Ingelheim Investigational Site 30 | Imst | Austria |
| Boehringer Ingelheim Investigational Site 31 | Innsbruck | Austria |
| Boehringer Ingelheim Investigational Site 32 | Innsbruck | Austria |
| Boehringer Ingelheim Investigational Site 33 | Innsbruck | Austria |
| Boehringer Ingelheim Investigational Site 34 | Judenburg | Austria |
| Boehringer Ingelheim Investigational Site 35 | Kapfenberg | 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 | Klagenfurt | Austria |
| Boehringer Ingelheim Investigational Site 40 | Knittelfeld | Austria |
| Boehringer Ingelheim Investigational Site 41 | Krems | Austria |
| Boehringer Ingelheim Investigational Site 42 | Kufstein | Austria |
| Boehringer Ingelheim Investigational Site 43 | Lassnitzhöhe | Austria |
| Boehringer Ingelheim Investigational Site 44 | Leibnitz, Styria | Austria |
| Boehringer Ingelheim Investigational Site 45 | Leoben | Austria |
| Boehringer Ingelheim Investigational Site 46 | Lienz | Austria |
| Boehringer Ingelheim Investigational Site 47 | Lienz | Austria |
| Boehringer Ingelheim Investigational Site 48 | Lilienfeld | Austria |
| Boehringer Ingelheim Investigational Site 49 | Linz | Austria |
| Boehringer Ingelheim Investigational Site 50 | Linz | Austria |
| Boehringer Ingelheim Investigational Site 51 | Melk | Austria |
| Boehringer Ingelheim Investigational Site 52 | Mürzzuschlag | Austria |
| Boehringer Ingelheim Investigational Site 53 | Neulengbach | Austria |
| Boehringer Ingelheim Investigational Site 54 | Neulengbach | Austria |
| Boehringer Ingelheim Investigational Site 55 | Neunkirchen | Austria |
| Boehringer Ingelheim Investigational Site 56 | Neunkirchen | Austria |
| Boehringer Ingelheim Investigational Site 57 | Neusiedl am See | Austria |
| Boehringer Ingelheim Investigational Site 58 | Oberwart | Austria |
| Boehringer Ingelheim Investigational Site 59 | Oberwart | Austria |
| Boehringer Ingelheim Investigational Site 60 | Oberwart | Austria |
| Boehringer Ingelheim Investigational Site 61 | Regelsbrunn | Austria |
| Boehringer Ingelheim Investigational Site 62 | Ried im Innkreis | Austria |
| Boehringer Ingelheim Investigational Site 63 | Ried im Innkreis | Austria |
| Boehringer Ingelheim Investigational Site 64 | Rohrbach | 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 | Salzburg | Austria |
| Boehringer Ingelheim Investigational Site 71 | Sankt Pölten | Austria |
| Boehringer Ingelheim Investigational Site 72 | Sankt Pölten | Austria |
| Boehringer Ingelheim Investigational Site 73 | Sankt Veit an der Glan | Austria |
| Boehringer Ingelheim Investigational Site 69 | Scheibbs | Austria |
| Boehringer Ingelheim Investigational Site 70 | St Johann im Pongau | Austria |
| Boehringer Ingelheim Investigational Site 74 | Telfs | Austria |
| Boehringer Ingelheim Investigational Site 75 | Tulln | Austria |
| Boehringer Ingelheim Investigational Site 76 | Tullnerbach-Lawies | Austria |
| Boehringer Ingelheim Investigational Site 100 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 101 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 102 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 103 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 104 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 105 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 106 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 107 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 84 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 85 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 86 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 87 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 88 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 89 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 90 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 91 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 92 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 93 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 94 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 95 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 96 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 97 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 98 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 99 | Vienna | Austria |
| Boehringer Ingelheim Investigational Site 77 | Villach | Austria |
| Boehringer Ingelheim Investigational Site 78 | Villach | Austria |
| Boehringer Ingelheim Investigational Site 79 | Villach-Warmbad | Austria |
| Boehringer Ingelheim Investigational Site 80 | Vöcklabruck | Austria |
| Boehringer Ingelheim Investigational Site 81 | Vöcklabruck | Austria |
| Boehringer Ingelheim Investigational Site 82 | Völkermarkt | Austria |
| Boehringer Ingelheim Investigational Site 83 | Wagna | Austria |
| Boehringer Ingelheim Investigational Site 108 | Wiener Neustadt | Austria |
| Boehringer Ingelheim Investigational Site 109 | Wolfsberg | Austria |
| Boehringer Ingelheim Investigational Site 110 | Zirl | Austria |
| Boehringer Ingelheim Investigational Site 111 | Zwettl Stadt | Austria |
| Boehringer Ingelheim Investigational Site 115 | Järvamaa | Estonia |
| Boehringer Ingelheim Investigational Site 114 | Kohtla-Järve | Estonia |
| Boehringer Ingelheim Investigational Site 121 | Kuressaare | Estonia |
| Boehringer Ingelheim Investigational Site 116 | Rakvere | Estonia |
| Boehringer Ingelheim Investigational Site 112 | Tallinn | Estonia |
| Boehringer Ingelheim Investigational Site 113 | Tallinn | Estonia |
| Boehringer Ingelheim Investigational Site 117 | Tartu | Estonia |
| Boehringer Ingelheim Investigational Site 118 | Valga | Estonia |
| Boehringer Ingelheim Investigational Site 119 | Viimsi | Estonia |
| Boehringer Ingelheim Investigational Site 120 | Viljandi | Estonia |
| Boehringer Ingelheim Investigational Site 283 | Almaty | Kazakhstan |
| Boehringer Ingelheim Investigational Site 284 | Astana | Kazakhstan |
| Boehringer Ingelheim Investigational Site 282 | Shymkent | Kazakhstan |
| Boehringer Ingelheim Investigational Site 193 | Alba Iulia | Romania |
| Boehringer Ingelheim Investigational Site 194 | Bacau | Romania |
| Boehringer Ingelheim Investigational Site 195 | Bacau | Romania |
| Boehringer Ingelheim Investigational Site 196 | Bacau | Romania |
| Boehringer Ingelheim Investigational Site 197 | Baia Mare | Romania |
| Boehringer Ingelheim Investigational Site 198 | Baia Mare | Romania |
| Boehringer Ingelheim Investigational Site 199 | Botoșani | Romania |
| Boehringer Ingelheim Investigational Site 200 | Brasov | Romania |
| Boehringer Ingelheim Investigational Site 201 | Brasov | Romania |
| Boehringer Ingelheim Investigational Site 202 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 203 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 204 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 205 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 206 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 207 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 208 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 209 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 210 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 211 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 212 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 213 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 214 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 215 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 216 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 217 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 218 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 219 | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site 220 | Buzău | Romania |
| Boehringer Ingelheim Investigational Site 221 | Buzău | Romania |
| Boehringer Ingelheim Investigational Site 222 | Campulung Muscel | Romania |
| Boehringer Ingelheim Investigational Site 223 | Cluj-Napoca | Romania |
| Boehringer Ingelheim Investigational Site 224 | Cluj-Napoca | Romania |
| Boehringer Ingelheim Investigational Site 225 | Constanța | Romania |
| Boehringer Ingelheim Investigational Site 226 | Constanța | Romania |
| Boehringer Ingelheim Investigational Site 227 | Constanța | 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 | Craiova | Romania |
| Boehringer Ingelheim Investigational Site 233 | Curtea de Argeş | Romania |
| Boehringer Ingelheim Investigational Site 234 | Focşani | Romania |
| Boehringer Ingelheim Investigational Site 235 | Focşani | Romania |
| Boehringer Ingelheim Investigational Site 236 | Galati | Romania |
| Boehringer Ingelheim Investigational Site 237 | Iași | Romania |
| Boehringer Ingelheim Investigational Site 238 | Iași | Romania |
| Boehringer Ingelheim Investigational Site 239 | Iași | Romania |
| Boehringer Ingelheim Investigational Site 240 | Medgidia | Romania |
| Boehringer Ingelheim Investigational Site 241 | Oradea | Romania |
| Boehringer Ingelheim Investigational Site 242 | Oradea | Romania |
| Boehringer Ingelheim Investigational Site 243 | Piatra Neamţ | Romania |
| Boehringer Ingelheim Investigational Site 244 | Piatra Neamţ | Romania |
| Boehringer Ingelheim Investigational Site 245 | Piteşti | Romania |
| Boehringer Ingelheim Investigational Site 246 | Piteşti | Romania |
| Boehringer Ingelheim Investigational Site 247 | Ploieşti | Romania |
| Boehringer Ingelheim Investigational Site 248 | Prahova | Romania |
| Boehringer Ingelheim Investigational Site 249 | Radauti | Romania |
| Boehringer Ingelheim Investigational Site 250 | Râmnicu Vâlcea | Romania |
| Boehringer Ingelheim Investigational Site 251 | Râmnicu Vâlcea | Romania |
| Boehringer Ingelheim Investigational Site 252 | Râmnicu Vâlcea | Romania |
| Boehringer Ingelheim Investigational Site 253 | Satu Mare | Romania |
| Boehringer Ingelheim Investigational Site 254 | Satu Mare | Romania |
| Boehringer Ingelheim Investigational Site 255 | Sibiu | Romania |
| Boehringer Ingelheim Investigational Site 256 | Sibiu | Romania |
| Boehringer Ingelheim Investigational Site 257 | Simleul Silvaniei | Romania |
| Boehringer Ingelheim Investigational Site 258 | Slobozia | Romania |
| Boehringer Ingelheim Investigational Site 259 | Suceava | Romania |
| Boehringer Ingelheim Investigational Site 260 | Targoviste | Romania |
| Boehringer Ingelheim Investigational Site 261 | Targoviste | Romania |
| Boehringer Ingelheim Investigational Site 262 | Târgu Mureş | Romania |
| Boehringer Ingelheim Investigational Site 263 | Târnăveni | Romania |
| Boehringer Ingelheim Investigational Site 264 | Târnăveni | Romania |
| Boehringer Ingelheim Investigational Site 265 | Timișoara | Romania |
| Boehringer Ingelheim Investigational Site 266 | Timișoara | Romania |
| Boehringer Ingelheim Investigational Site 267 | Timișoara | Romania |
| Boehringer Ingelheim Investigational Site 268 | Timișoara | Romania |
| Boehringer Ingelheim Investigational Site 269 | Tulcea | Romania |
| Boehringer Ingelheim Investigational Site 270 | Tulcea | Romania |
| Boehringer Ingelheim Investigational Site 271 | Tulcea | Romania |
| Boehringer Ingelheim Investigational Site 272 | Turda | Romania |
| Boehringer Ingelheim Investigational Site 273 | Turnu Măgurele | Romania |
| Boehringer Ingelheim Investigational Site 274 | Zalău | Romania |
| Boehringer Ingelheim Investigational Site 275 | Belgrade | Serbia |
| Boehringer Ingelheim Investigational Site 276 | Belgrade | Serbia |
| Boehringer Ingelheim Investigational Site 278 | Kragujevac | Serbia |
| Boehringer Ingelheim Investigational Site 281 | Kraljevo | Serbia |
| Boehringer Ingelheim Investigational Site 279 | Niš | Serbia |
| Boehringer Ingelheim Investigational Site 277 | Novi Sad | Serbia |
| Boehringer Ingelheim Investigational Site 280 | Užice | Serbia |
| Boehringer Ingelheim Investigational Site 122 | Banská Bystrica | Slovakia |
| Boehringer Ingelheim Investigational Site 123 | Bardejov | Slovakia |
| Boehringer Ingelheim Investigational Site 124 | Bardejov | 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 | Bratislava | Slovakia |
| Boehringer Ingelheim Investigational Site 133 | Brezno | Slovakia |
| Boehringer Ingelheim Investigational Site 134 | Detva | Slovakia |
| Boehringer Ingelheim Investigational Site 135 | Dolný Kubín | Slovakia |
| Boehringer Ingelheim Investigational Site 136 | Dolný Kubín | Slovakia |
| Boehringer Ingelheim Investigational Site 137 | Hlohovec | Slovakia |
| Boehringer Ingelheim Investigational Site 138 | Hlohovec | Slovakia |
| Boehringer Ingelheim Investigational Site 139 | Humenné | Slovakia |
| Boehringer Ingelheim Investigational Site 140 | Kežmarok | Slovakia |
| Boehringer Ingelheim Investigational Site 141 | Kežmarok | Slovakia |
| Boehringer Ingelheim Investigational Site 142 | Komárno | Slovakia |
| Boehringer Ingelheim Investigational Site 143 | Košice | Slovakia |
| Boehringer Ingelheim Investigational Site 144 | Košice | Slovakia |
| Boehringer Ingelheim Investigational Site 145 | Košice | Slovakia |
| Boehringer Ingelheim Investigational Site 146 | Košice | Slovakia |
| Boehringer Ingelheim Investigational Site 147 | Košice | Slovakia |
| Boehringer Ingelheim Investigational Site 148 | Krompachy | Slovakia |
| Boehringer Ingelheim Investigational Site 149 | Liptovský Mikulás | Slovakia |
| Boehringer Ingelheim Investigational Site 150 | Lučenec | Slovakia |
| Boehringer Ingelheim Investigational Site 151 | Lučenec | Slovakia |
| Boehringer Ingelheim Investigational Site 152 | Lučenec | Slovakia |
| Boehringer Ingelheim Investigational Site 153 | Martin | Slovakia |
| Boehringer Ingelheim Investigational Site 154 | Martin | Slovakia |
| Boehringer Ingelheim Investigational Site 155 | Myjava | Slovakia |
| Boehringer Ingelheim Investigational Site 156 | Námestovo | 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 | Nitra | Slovakia |
| Boehringer Ingelheim Investigational Site 161 | Pezinok | Slovakia |
| Boehringer Ingelheim Investigational Site 162 | Piešťany | Slovakia |
| Boehringer Ingelheim Investigational Site 163 | Prešov | Slovakia |
| Boehringer Ingelheim Investigational Site 164 | Prešov | Slovakia |
| Boehringer Ingelheim Investigational Site 165 | Prešov | Slovakia |
| Boehringer Ingelheim Investigational Site 166 | Prešov | Slovakia |
| Boehringer Ingelheim Investigational Site 169 | Skalica | Slovakia |
| Boehringer Ingelheim Investigational Site 170 | Stará Lubovna | Slovakia |
| Boehringer Ingelheim Investigational Site 167 | Šahy | Slovakia |
| Boehringer Ingelheim Investigational Site 168 | Šaľa | Slovakia |
| Boehringer Ingelheim Investigational Site 171 | Šurany | Slovakia |
| Boehringer Ingelheim Investigational Site 172 | Topoľčany | Slovakia |
| Boehringer Ingelheim Investigational Site 173 | Trebišov | Slovakia |
| Boehringer Ingelheim Investigational Site 174 | Trencín | Slovakia |
| Boehringer Ingelheim Investigational Site 175 | Trnava | Slovakia |
| Boehringer Ingelheim Investigational Site 176 | Trnava | Slovakia |
| Boehringer Ingelheim Investigational Site 177 | Trstená | Slovakia |
| Boehringer Ingelheim Investigational Site 178 | Vranov Nad Top?ou | Slovakia |
| Boehringer Ingelheim Investigational Site 182 | Zlaté Moravce | Slovakia |
| Boehringer Ingelheim Investigational Site 181 | Zvolen | Slovakia |
| Boehringer Ingelheim Investigational Site 179 | Žiar nad Hronom | Slovakia |
| Boehringer Ingelheim Investigational Site 180 | Žilina | Slovakia |
| Boehringer Ingelheim Investigational Site 183 | Celje | Slovenia |
| Boehringer Ingelheim Investigational Site 184 | Lesce | Slovenia |
| Boehringer Ingelheim Investigational Site 185 | Ljubljana | Slovenia |
| Boehringer Ingelheim Investigational Site 186 | Ljubljana | Slovenia |
| Boehringer Ingelheim Investigational Site 187 | Maribor | Slovenia |
| Boehringer Ingelheim Investigational Site 188 | Maribor | Slovenia |
| Boehringer Ingelheim Investigational Site 190 | Sempeter | Slovenia |
| Boehringer Ingelheim Investigational Site 191 | Sempeter | Slovenia |
| Boehringer Ingelheim Investigational Site 189 | Slovenj Gradec | Slovenia |
| Boehringer Ingelheim Investigational Site 192 | Velenje | Slovenia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Patients from Treated Set (TS) who were documented to have taken at least one dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Patients with Parkinson's disease in routine clinical practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | For 19 patients no data for age was documented, so the age was available for N=1795 patients | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Gender | The documentation of gender was missing for 15 patients. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Adverse Events | The number of patients with any adverse events (AEs), patients with drug-related AEs. | Patients from the Treated Set (TS). | Posted | Number | participants | From the treatment initiation to the end of study, on average 92.9 days |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Proportion of Patients With Withdrawals Due to Adverse Events. | Patients who discontinued treatment due to adverse events including deaths. | Patients from the Treated Set (TS). | Posted | Number | proportion of participants | 16 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score | 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. | Patients from the Full Analysis Set (FAS) which includes all treated patients who have data for at least one post baseline visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline and the end of study (up to 16 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression of Improvement (CGI-I) Responder Rate | 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. | Patients from FAS | Posted | Number | percentage of participants | Baseline and the end of study (up to 16 weeks) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction | 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. | Patients from FAS with evaluable data in VAS at baseline and at visit 3. | Posted | Mean | Standard Deviation | units on a scale | Baseline and the end of study (up to 16 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score | 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 | Patients from FAS with evaluable data in the Morisky scale for baseline and at visit 3. | Posted | Mean | Standard Deviation | units on a scale | Baseline and the end of study (up to 16 weeks) |
|
|
From the treatment initiation to the end of study, on average 92.9 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | Patients with Parkinson's disease in routine clinical practice. | 4 | 1,814 | 0 | 1,814 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral insult | Nervous system disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Gambling | Psychiatric disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Heart failure | Vascular disorders | MEDDRA 16.1 | Systematic Assessment |
|
Not provided
There was no PI assigned for the overall study.
Not provided
There was no PI assigned for the overall study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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