Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life
- Conditions
- Parkinson Disease
- Registration Number
- NCT01100073
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The study will compare the effect of pramipexole on different types of tremor and particularly kinetic tremor in early and advanced Parkinson's disease patients and will evaluate the course of tremor measured with spiralometry under pramipexole treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1703
- Idiopathic Parkinson's disease with or without fluctuations
- Indication for treatment with pramipexole (Mirapexin®)
- Presence of at least mild tremor symptoms (as judged by the treating physician)
- Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
- Ongoing treatment with pramipexole (Mirapexin®)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance Week 0 to weeks 9-16 (Visit 3) Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to end of study. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand) Week 0 to weeks 9-16 (Visit 3) Change (reduction) in tremor amplitude from baseline to end of study for the left hand
Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance Week 0 to weeks 9-16 (Visit 3) Change (reduction) in PDQ-39 score (quality of life) from baseline to end of study. Score ranging from 0-100 (0=perfect health, 100=worst health as assessed by the measure)
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand) Week 0 to weeks 9-16 (Visit 3) Change (reduction) in tremor amplitude from baseline to end of study for the right hand
Change From Baseline in UPDRS Part III Score at the End of Maintenance Week 0 to weeks 9-16 Change (reduction) in UPDRS Part III score (motor function) from baseline to end of study. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3) Week 0 to weeks 9-16 (Visit 3) Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)
- Secondary Outcome Measures
Name Time Method Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration Enter Week 0 to weeks 1-8 (Visit 2) Change (reduction) from baseline in tremor score, derived from UPDRS from baseline to Visit 2. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)
Final Dose Distribution Enter Week 0 to weeks 9-16 (Visit 3) Final Mirapexin® dose distribution at the end of study
Change From Baseline in UPDRS Part II Score at the End of Up-titration Enter Week 0 to weeks 1-8 (Visit 2) Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to Visit 2. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)
Change From Baseline in UPDRS Part III Score at the End of Up-titration Enter Week 0 to weeks 1-8 (Visit 2) Change (reduction) in UPDRS Part III score (motor function) from baseline to Visit 2. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
Number of Premature Discontinuations Week 0 to weeks 9-16 (end of study) Number of patients discontinuing the study prematurely
Incidence, Relationship and Seriousness of Adverse Events Week 0 to weeks 9-16 (end of study) Total number of adverse events (AEs), causality and level of seriousness
Trial Locations
- Locations (215)
Boehringer Ingelheim Investigational Site 89
🇷🇴Focsani, Romania
Boehringer Ingelheim Investigational Site 102
🇷🇴Pascani, Romania
Boehringer Ingelheim Investigational Site 117
🇷🇴Teleorman, Romania
Boehringer Ingelheim Investigational Site 2
🇪🇪Tallinn, Estonia
Boehringer Ingelheim Investigational Site 9
🇱🇻Kuldiga, Latvia
Boehringer Ingelheim Investigational Site 149
🇸🇰Bratislava, Slovakia
Boehringer Ingelheim Investigational Site 6
🇪🇪Rakvere, Estonia
Boehringer Ingelheim Investigational Site 5
🇪🇪Keila, Estonia
Boehringer Ingelheim Investigational Site 23
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 35
🇷🇴Arges, Romania
Boehringer Ingelheim Investigational Site 66
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 156
🇸🇰Humenné, Slovakia
Boehringer Ingelheim Investigational Site 166
🇸🇰Liptovský Mikulás, Slovakia
Boehringer Ingelheim Investigational Site 168
🇸🇰Martin, Slovakia
Boehringer Ingelheim Investigational Site 157
🇸🇰Ilava, Slovakia
Boehringer Ingelheim Investigational Site 163
🇸🇰Kosice- Saca, Slovakia
Boehringer Ingelheim Investigational Site 160
🇸🇰Kosice, Slovakia
Boehringer Ingelheim Investigational Site 159
🇸🇰Kosice, Slovakia
Boehringer Ingelheim Investigational Site 169
🇸🇰Nitra, Slovakia
Boehringer Ingelheim Investigational Site 215
🇺🇦Lviv, Ukraine
Boehringer Ingelheim Investigational Site 3
🇪🇪Tallinn, Estonia
Boehringer Ingelheim Investigational Site 11
🇱🇻Limbazi, Latvia
Boehringer Ingelheim Investigational Site 50
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 73
🇷🇴Buzau, Romania
Boehringer Ingelheim Investigational Site 92
🇷🇴Galati, Romania
Boehringer Ingelheim Investigational Site 94
🇷🇴Hunedoara, Romania
Boehringer Ingelheim Investigational Site 96
🇷🇴Iasi, Romania
Boehringer Ingelheim Investigational Site 104
🇷🇴Petrosani, Romania
Boehringer Ingelheim Investigational Site 105
🇷🇴Piatra Neamt, Romania
Boehringer Ingelheim Investigational Site 106
🇷🇴Prahova, Romania
Boehringer Ingelheim Investigational Site 107
🇷🇴Prahova, Romania
Boehringer Ingelheim Investigational Site 111
🇷🇴Satu Mare, Romania
Boehringer Ingelheim Investigational Site 112
🇷🇴Sibiu, Romania
Boehringer Ingelheim Investigational Site 113
🇷🇴Sibiu, Romania
Boehringer Ingelheim Investigational Site 116
🇷🇴Suceava, Romania
Boehringer Ingelheim Investigational Site 118
🇷🇴Tg. Mures, Romania
Boehringer Ingelheim Investigational Site 121
🇷🇴Timisoara, Romania
Boehringer Ingelheim Investigational Site 131
🇷🇺Krasnodar, Russian Federation
Boehringer Ingelheim Investigational Site 123
🇷🇴Tulcea, Romania
Boehringer Ingelheim Investigational Site 127
🇷🇺Moscow, Russian Federation
Boehringer Ingelheim Investigational Site 124
🇷🇴Tulcea, Romania
Boehringer Ingelheim Investigational Site 130
🇷🇺Krasnoyarsk, Russian Federation
Boehringer Ingelheim Investigational Site 133
🇷🇺Saint-Petersburg, Russian Federation
Boehringer Ingelheim Investigational Site 125
🇷🇺Moscow, Russian Federation
Boehringer Ingelheim Investigational Site 132
🇷🇺Saint-Petersburg, Russian Federation
Boehringer Ingelheim Investigational Site 140
🇷🇸Kragujevac, Serbia
Boehringer Ingelheim Investigational Site 142
🇷🇸Nis, Serbia
Boehringer Ingelheim Investigational Site 137
🇷🇸Novi Sad, Serbia
Boehringer Ingelheim Investigational Site 145
🇷🇸Uzice, Serbia
Boehringer Ingelheim Investigational Site 139
🇷🇸Valjevo, Serbia
Boehringer Ingelheim Investigational Site 144
🇷🇸Vranje, Serbia
Boehringer Ingelheim Investigational Site 155
🇸🇰?adca, Slovakia
Boehringer Ingelheim Investigational Site 146
🇸🇰Banská Bystrica, Slovakia
Boehringer Ingelheim Investigational Site 150
🇸🇰Bratislava, Slovakia
Boehringer Ingelheim Investigational Site 161
🇸🇰Kosice, Slovakia
Boehringer Ingelheim Investigational Site 164
🇸🇰Krompachy, Slovakia
Boehringer Ingelheim Investigational Site 165
🇸🇰Levice, Slovakia
Boehringer Ingelheim Investigational Site 177
🇸🇰Presov, Slovakia
Boehringer Ingelheim Investigational Site 180
🇸🇰Revúca, Slovakia
Boehringer Ingelheim Investigational Site 183
🇸🇰Roznava, Slovakia
Boehringer Ingelheim Investigational Site 189
🇸🇰Trebisov, Slovakia
Boehringer Ingelheim Investigational Site 186
🇸🇰Skalica, Slovakia
Boehringer Ingelheim Investigational Site 188
🇸🇰Surany, Slovakia
Boehringer Ingelheim Investigational Site 190
🇸🇰Tren?in, Slovakia
Boehringer Ingelheim Investigational Site 202
🇸🇮Ljubljana, Slovenia
Boehringer Ingelheim Investigational Site 207
🇸🇮Maribor, Slovenia
Boehringer Ingelheim Investigational Site 208
🇸🇮Maribor, Slovenia
Boehringer Ingelheim Investigational Site 213
🇺🇦Vinnitsa, Ukraine
Boehringer Ingelheim Investigational Site 4
🇪🇪Kohtla-Järve, Estonia
Boehringer Ingelheim Investigational Site 8
🇪🇪Valga, Estonia
Boehringer Ingelheim Investigational Site 12
🇱🇻Liepaja, Latvia
Boehringer Ingelheim Investigational Site 10
🇱🇻Limbazi, Latvia
Boehringer Ingelheim Investigational Site 16
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 18
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 19
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 20
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 21
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 22
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 24
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 26
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 28
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 27
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 30
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 31
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 32
🇷🇴Aiud, Romania
Boehringer Ingelheim Investigational Site 34
🇷🇴Arges, Romania
Boehringer Ingelheim Investigational Site 36
🇷🇴Arges, Romania
Boehringer Ingelheim Investigational Site 38
🇷🇴Arges, Romania
Boehringer Ingelheim Investigational Site 41
🇷🇴Bacau, Romania
Boehringer Ingelheim Investigational Site 39
🇷🇴Arges, Romania
Boehringer Ingelheim Investigational Site 40
🇷🇴Bacau, Romania
Boehringer Ingelheim Investigational Site 42
🇷🇴Bistrita, Romania
Boehringer Ingelheim Investigational Site 45
🇷🇴Braila, Romania
Boehringer Ingelheim Investigational Site 43
🇷🇴Botosani, Romania
Boehringer Ingelheim Investigational Site 46
🇷🇴Braila, Romania
Boehringer Ingelheim Investigational Site 47
🇷🇴Brasov, Romania
Boehringer Ingelheim Investigational Site 48
🇷🇴Brasov, Romania
Boehringer Ingelheim Investigational Site 49
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 54
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 74
🇷🇴Caracal, Romania
Boehringer Ingelheim Investigational Site 51
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 52
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 55
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 57
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 58
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 59
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 61
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 63
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 67
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 65
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 68
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 71
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 72
🇷🇴Buzau, Romania
Boehringer Ingelheim Investigational Site 75
🇷🇴Cluj, Romania
Boehringer Ingelheim Investigational Site 79
🇷🇴Cluj, Romania
Boehringer Ingelheim Investigational Site 78
🇷🇴Cluj, Romania
Boehringer Ingelheim Investigational Site 80
🇷🇴Cluj, Romania
Boehringer Ingelheim Investigational Site 84
🇷🇴Craiova, Romania
Boehringer Ingelheim Investigational Site 81
🇷🇴Constanta, Romania
Boehringer Ingelheim Investigational Site 83
🇷🇴Craiova, Romania
Boehringer Ingelheim Investigational Site 82
🇷🇴Constanta, Romania
Boehringer Ingelheim Investigational Site 86
🇷🇴Craiova, Romania
Boehringer Ingelheim Investigational Site 93
🇷🇴Hunedoara, Romania
Boehringer Ingelheim Investigational Site 91
🇷🇴Galati, Romania
Boehringer Ingelheim Investigational Site 97
🇷🇴Iasi, Romania
Boehringer Ingelheim Investigational Site 99
🇷🇴Lugoj, Romania
Boehringer Ingelheim Investigational Site 108
🇷🇴Prahova, Romania
Boehringer Ingelheim Investigational Site 109
🇷🇴Radauti, Romania
Boehringer Ingelheim Investigational Site 120
🇷🇴Timisoara, Romania
Boehringer Ingelheim Investigational Site 151
🇸🇰Bratislava, Slovakia
Boehringer Ingelheim Investigational Site 152
🇸🇰Bratislava, Slovakia
Boehringer Ingelheim Investigational Site 148
🇸🇰Bratislava, Slovakia
Boehringer Ingelheim Investigational Site 153
🇸🇰Bratislava, Slovakia
Boehringer Ingelheim Investigational Site 167
🇸🇰Lucenec, Slovakia
Boehringer Ingelheim Investigational Site 170
🇸🇰Nitra, Slovakia
Boehringer Ingelheim Investigational Site 171
🇸🇰Nitra, Slovakia
Boehringer Ingelheim Investigational Site 178
🇸🇰Presov, Slovakia
Boehringer Ingelheim Investigational Site 179
🇸🇰Presov, Slovakia
Boehringer Ingelheim Investigational Site 181
🇸🇰Rimavská Sobota, Slovakia
Boehringer Ingelheim Investigational Site 182
🇸🇰Roznava, Slovakia
Boehringer Ingelheim Investigational Site 185
🇸🇰Sered, Slovakia
Boehringer Ingelheim Investigational Site 184
🇸🇰Sal'a, Slovakia
Boehringer Ingelheim Investigational Site 187
🇸🇰Stropkov, Slovakia
Boehringer Ingelheim Investigational Site 195
🇸🇰Ziar N/Hronom, Slovakia
Boehringer Ingelheim Investigational Site 193
🇸🇰Trstená, Slovakia
Boehringer Ingelheim Investigational Site 196
🇸🇰Zilina, Slovakia
Boehringer Ingelheim Investigational Site 176
🇸🇰Povazská Bystrica, Slovakia
Boehringer Ingelheim Investigational Site 175
🇸🇰Pies?any, Slovakia
Boehringer Ingelheim Investigational Site 1
🇪🇪Tallinn, Estonia
Boehringer Ingelheim Investigational Site 29
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 70
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 76
🇷🇴Cluj, Romania
Boehringer Ingelheim Investigational Site 90
🇷🇴Focsani, Romania
Boehringer Ingelheim Investigational Site 100
🇷🇴Maramures, Romania
Boehringer Ingelheim Investigational Site 103
🇷🇴Pascani, Romania
Boehringer Ingelheim Investigational Site 114
🇷🇴Slatina, Romania
Boehringer Ingelheim Investigational Site 60
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 62
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 37
🇷🇴Arges, Romania
Boehringer Ingelheim Investigational Site 53
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 85
🇷🇴Craiova, Romania
Boehringer Ingelheim Investigational Site 88
🇷🇴Deva, Romania
Boehringer Ingelheim Investigational Site 110
🇷🇴Resita, Romania
Boehringer Ingelheim Investigational Site 122
🇷🇴Timisoara, Romania
Boehringer Ingelheim Investigational Site 135
🇷🇸Belgrade, Serbia
Boehringer Ingelheim Investigational Site 143
🇷🇸Sombor, Serbia
Boehringer Ingelheim Investigational Site 147
🇸🇰Bardejov, Slovakia
Boehringer Ingelheim Investigational Site 126
🇷🇺Moscow, Russian Federation
Boehringer Ingelheim Investigational Site 7
🇪🇪Tartu, Estonia
Boehringer Ingelheim Investigational Site 13
🇱🇻Liepaja, Latvia
Boehringer Ingelheim Investigational Site 15
🇱🇻Liepaja, Latvia
Boehringer Ingelheim Investigational Site 17
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 25
🇱🇻Riga, Latvia
Boehringer Ingelheim Investigational Site 44
🇷🇴Botosani, Romania
Boehringer Ingelheim Investigational Site 69
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 87
🇷🇴Deva, Romania
Boehringer Ingelheim Investigational Site 95
🇷🇴Iasi, Romania
Boehringer Ingelheim Investigational Site 138
🇷🇸Krusevac, Serbia
Boehringer Ingelheim Investigational Site 14
🇱🇻Liepaja, Latvia
Boehringer Ingelheim Investigational Site 33
🇷🇴Arges, Romania
Boehringer Ingelheim Investigational Site 56
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 64
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 77
🇷🇴Cluj, Romania
Boehringer Ingelheim Investigational Site 98
🇷🇴Iasi, Romania
Boehringer Ingelheim Investigational Site 101
🇷🇴Orastie, Romania
Boehringer Ingelheim Investigational Site 115
🇷🇴Suceava, Romania
Boehringer Ingelheim Investigational Site 119
🇷🇴Timisoara, Romania
Boehringer Ingelheim Investigational Site 134
🇷🇺Saint-Petersburg, Russian Federation
Boehringer Ingelheim Investigational Site 129
🇷🇺Tomsk, Russian Federation
Boehringer Ingelheim Investigational Site 136
🇷🇸Belgrade, Serbia
Boehringer Ingelheim Investigational Site 141
🇷🇸Nis, Serbia
Boehringer Ingelheim Investigational Site 158
🇸🇰Komárno, Slovakia
Boehringer Ingelheim Investigational Site 162
🇸🇰Kosice, Slovakia
Boehringer Ingelheim Investigational Site 174
🇸🇰Pezinok, Slovakia
Boehringer Ingelheim Investigational Site 192
🇸🇰Trnava, Slovakia
Boehringer Ingelheim Investigational Site 194
🇸🇰Vel'ke Kapusany, Slovakia
Boehringer Ingelheim Investigational Site 197
🇸🇰Zilina, Slovakia
Boehringer Ingelheim Investigational Site 199
🇸🇰Zvolen, Slovakia
Boehringer Ingelheim Investigational Site 205
🇸🇮Bled, Slovenia
Boehringer Ingelheim Investigational Site 204
🇸🇮Sempeter pri Gorici, Slovenia
Boehringer Ingelheim Investigational Site 128
🇷🇺Novosibirsk, Russian Federation
Boehringer Ingelheim Investigational Site 154
🇸🇰Brezno, Slovakia
Boehringer Ingelheim Investigational Site 172
🇸🇰Nováky, Slovakia
Boehringer Ingelheim Investigational Site 173
🇸🇰Nové Mesto n/ Váhom, Slovakia
Boehringer Ingelheim Investigational Site 191
🇸🇰Trnava, Slovakia
Boehringer Ingelheim Investigational Site 198
🇸🇰Zlaté Moravce, Slovakia
Boehringer Ingelheim Investigational Site 201
🇸🇮Ljubljana, Slovenia
Boehringer Ingelheim Investigational Site 210
🇸🇮Maribor, Slovenia
Boehringer Ingelheim Investigational Site 203
🇸🇮Sempeter pri Gorici, Slovenia
Boehringer Ingelheim Investigational Site 214
🇺🇦Ternopil, Ukraine
Boehringer Ingelheim Investigational Site 200
🇸🇰Zvolen, Slovakia
Boehringer Ingelheim Investigational Site 206
🇸🇮Celje, Slovenia
Boehringer Ingelheim Investigational Site 209
🇸🇮Maribor, Slovenia
Boehringer Ingelheim Investigational Site 212
🇺🇦Kharkiv, Ukraine
Boehringer Ingelheim Investigational Site 211
🇺🇦Kyiv, Ukraine