Parkinson Disease Clinical Trial
Official title:
Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life
| NCT number | NCT01100073 |
| Other study ID # | 248.657 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | March 18, 2010 |
| Last updated | March 14, 2014 |
| Start date | February 2008 |
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.
| Status | Completed |
| Enrollment | 1703 |
| Est. completion date | |
| Est. primary completion date | August 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: 1. Idiopathic Parkinson's disease with or without fluctuations 2. Indication for treatment with pramipexole (Mirapexin®) 3. Presence of at least mild tremor symptoms (as judged by the treating physician) Exclusion Criteria: 1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients. 2. Ongoing treatment with pramipexole (Mirapexin®) |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Estonia | Boehringer Ingelheim Investigational Site 5 | Keila | |
| Estonia | Boehringer Ingelheim Investigational Site 4 | Kohtla-Järve | |
| Estonia | Boehringer Ingelheim Investigational Site 6 | Rakvere | |
| Estonia | Boehringer Ingelheim Investigational Site 1 | Tallinn | |
| Estonia | Boehringer Ingelheim Investigational Site 2 | Tallinn | |
| Estonia | Boehringer Ingelheim Investigational Site 3 | Tallinn | |
| Estonia | Boehringer Ingelheim Investigational Site 7 | Tartu | |
| Estonia | Boehringer Ingelheim Investigational Site 8 | Valga | |
| Latvia | Boehringer Ingelheim Investigational Site 9 | Kuldiga | |
| Latvia | Boehringer Ingelheim Investigational Site 12 | Liepaja | |
| Latvia | Boehringer Ingelheim Investigational Site 13 | Liepaja | |
| Latvia | Boehringer Ingelheim Investigational Site 14 | Liepaja | |
| Latvia | Boehringer Ingelheim Investigational Site 15 | Liepaja | |
| Latvia | Boehringer Ingelheim Investigational Site 10 | Limbazi | |
| Latvia | Boehringer Ingelheim Investigational Site 11 | Limbazi | |
| Latvia | Boehringer Ingelheim Investigational Site 16 | Riga | |
| Latvia | Boehringer Ingelheim Investigational Site 17 | 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 23 | Riga | |
| Latvia | Boehringer Ingelheim Investigational Site 24 | Riga | |
| Latvia | Boehringer Ingelheim Investigational Site 25 | Riga | |
| Latvia | Boehringer Ingelheim Investigational Site 26 | Riga | |
| Latvia | Boehringer Ingelheim Investigational Site 27 | Riga | |
| Latvia | Boehringer Ingelheim Investigational Site 28 | Riga | |
| Latvia | Boehringer Ingelheim Investigational Site 29 | Riga | |
| Latvia | Boehringer Ingelheim Investigational Site 30 | Riga | |
| Latvia | Boehringer Ingelheim Investigational Site 31 | Riga | |
| Romania | Boehringer Ingelheim Investigational Site 32 | Aiud | |
| Romania | Boehringer Ingelheim Investigational Site 33 | Arges | |
| Romania | Boehringer Ingelheim Investigational Site 34 | Arges | |
| Romania | Boehringer Ingelheim Investigational Site 35 | Arges | |
| Romania | Boehringer Ingelheim Investigational Site 36 | Arges | |
| Romania | Boehringer Ingelheim Investigational Site 37 | Arges | |
| Romania | Boehringer Ingelheim Investigational Site 38 | Arges | |
| Romania | Boehringer Ingelheim Investigational Site 39 | Arges | |
| Romania | Boehringer Ingelheim Investigational Site 40 | Bacau | |
| Romania | Boehringer Ingelheim Investigational Site 41 | Bacau | |
| Romania | Boehringer Ingelheim Investigational Site 42 | Bistrita | |
| Romania | Boehringer Ingelheim Investigational Site 43 | Botosani | |
| Romania | Boehringer Ingelheim Investigational Site 44 | Botosani | |
| Romania | Boehringer Ingelheim Investigational Site 45 | Braila | |
| 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 50 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 51 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 52 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 53 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 54 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 55 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 56 | 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 60 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 61 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 62 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 63 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 64 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 65 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 66 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 67 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 68 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 69 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 70 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 71 | Bucuresti | |
| Romania | Boehringer Ingelheim Investigational Site 72 | Buzau | |
| Romania | Boehringer Ingelheim Investigational Site 73 | Buzau | |
| Romania | Boehringer Ingelheim Investigational Site 74 | Caracal | |
| Romania | Boehringer Ingelheim Investigational Site 75 | Cluj | |
| Romania | Boehringer Ingelheim Investigational Site 76 | Cluj | |
| Romania | Boehringer Ingelheim Investigational Site 77 | Cluj | |
| Romania | Boehringer Ingelheim Investigational Site 78 | Cluj | |
| Romania | Boehringer Ingelheim Investigational Site 79 | Cluj | |
| Romania | Boehringer Ingelheim Investigational Site 80 | Cluj | |
| Romania | Boehringer Ingelheim Investigational Site 81 | Constanta | |
| Romania | Boehringer Ingelheim Investigational Site 82 | Constanta | |
| Romania | Boehringer Ingelheim Investigational Site 83 | Craiova | |
| Romania | Boehringer Ingelheim Investigational Site 84 | Craiova | |
| Romania | Boehringer Ingelheim Investigational Site 85 | Craiova | |
| Romania | Boehringer Ingelheim Investigational Site 86 | Craiova | |
| Romania | Boehringer Ingelheim Investigational Site 87 | Deva | |
| Romania | Boehringer Ingelheim Investigational Site 88 | Deva | |
| Romania | Boehringer Ingelheim Investigational Site 89 | Focsani | |
| Romania | Boehringer Ingelheim Investigational Site 90 | Focsani | |
| Romania | Boehringer Ingelheim Investigational Site 91 | Galati | |
| Romania | Boehringer Ingelheim Investigational Site 92 | Galati | |
| Romania | Boehringer Ingelheim Investigational Site 93 | Hunedoara | |
| Romania | Boehringer Ingelheim Investigational Site 94 | Hunedoara | |
| Romania | Boehringer Ingelheim Investigational Site 95 | Iasi | |
| Romania | Boehringer Ingelheim Investigational Site 96 | Iasi | |
| Romania | Boehringer Ingelheim Investigational Site 97 | Iasi | |
| Romania | Boehringer Ingelheim Investigational Site 98 | Iasi | |
| Romania | Boehringer Ingelheim Investigational Site 99 | Lugoj | |
| Romania | Boehringer Ingelheim Investigational Site 100 | Maramures | |
| Romania | Boehringer Ingelheim Investigational Site 101 | Orastie | |
| Romania | Boehringer Ingelheim Investigational Site 102 | Pascani | |
| Romania | Boehringer Ingelheim Investigational Site 103 | Pascani | |
| 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 108 | Prahova | |
| Romania | Boehringer Ingelheim Investigational Site 109 | Radauti | |
| Romania | Boehringer Ingelheim Investigational Site 110 | Resita | |
| 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 114 | Slatina | |
| Romania | Boehringer Ingelheim Investigational Site 115 | Suceava | |
| Romania | Boehringer Ingelheim Investigational Site 116 | Suceava | |
| Romania | Boehringer Ingelheim Investigational Site 117 | Teleorman | |
| Romania | Boehringer Ingelheim Investigational Site 118 | Tg. Mures | |
| Romania | Boehringer Ingelheim Investigational Site 119 | Timisoara | |
| Romania | Boehringer Ingelheim Investigational Site 120 | Timisoara | |
| Romania | Boehringer Ingelheim Investigational Site 121 | Timisoara | |
| Romania | Boehringer Ingelheim Investigational Site 122 | Timisoara | |
| Romania | Boehringer Ingelheim Investigational Site 123 | Tulcea | |
| Romania | Boehringer Ingelheim Investigational Site 124 | Tulcea | |
| Russian Federation | Boehringer Ingelheim Investigational Site 131 | Krasnodar | |
| Russian Federation | Boehringer Ingelheim Investigational Site 130 | Krasnoyarsk | |
| Russian Federation | Boehringer Ingelheim Investigational Site 125 | Moscow | |
| Russian Federation | Boehringer Ingelheim Investigational Site 126 | Moscow | |
| Russian Federation | Boehringer Ingelheim Investigational Site 127 | Moscow | |
| Russian Federation | Boehringer Ingelheim Investigational Site 128 | Novosibirsk | |
| Russian Federation | Boehringer Ingelheim Investigational Site 132 | Saint-Petersburg | |
| Russian Federation | Boehringer Ingelheim Investigational Site 133 | Saint-Petersburg | |
| Russian Federation | Boehringer Ingelheim Investigational Site 134 | Saint-Petersburg | |
| Russian Federation | Boehringer Ingelheim Investigational Site 129 | Tomsk | |
| Serbia | Boehringer Ingelheim Investigational Site 135 | Belgrade | |
| Serbia | Boehringer Ingelheim Investigational Site 136 | Belgrade | |
| Serbia | Boehringer Ingelheim Investigational Site 140 | Kragujevac | |
| Serbia | Boehringer Ingelheim Investigational Site 138 | Krusevac | |
| Serbia | Boehringer Ingelheim Investigational Site 141 | Nis | |
| Serbia | Boehringer Ingelheim Investigational Site 142 | Nis | |
| Serbia | Boehringer Ingelheim Investigational Site 137 | Novi Sad | |
| Serbia | Boehringer Ingelheim Investigational Site 143 | Sombor | |
| Serbia | Boehringer Ingelheim Investigational Site 145 | Uzice | |
| Serbia | Boehringer Ingelheim Investigational Site 139 | Valjevo | |
| Serbia | Boehringer Ingelheim Investigational Site 144 | Vranje | |
| Slovakia | Boehringer Ingelheim Investigational Site 155 | ?adca | |
| Slovakia | Boehringer Ingelheim Investigational Site 146 | Banská Bystrica | |
| Slovakia | Boehringer Ingelheim Investigational Site 147 | Bardejov | |
| Slovakia | Boehringer Ingelheim Investigational Site 148 | Bratislava | |
| Slovakia | Boehringer Ingelheim Investigational Site 149 | Bratislava | |
| Slovakia | Boehringer Ingelheim Investigational Site 150 | Bratislava | |
| Slovakia | Boehringer Ingelheim Investigational Site 151 | Bratislava | |
| Slovakia | Boehringer Ingelheim Investigational Site 152 | Bratislava | |
| Slovakia | Boehringer Ingelheim Investigational Site 153 | Bratislava | |
| Slovakia | Boehringer Ingelheim Investigational Site 154 | Brezno | |
| Slovakia | Boehringer Ingelheim Investigational Site 156 | Humenné | |
| Slovakia | Boehringer Ingelheim Investigational Site 157 | Ilava | |
| Slovakia | Boehringer Ingelheim Investigational Site 158 | Komárno | |
| Slovakia | Boehringer Ingelheim Investigational Site 159 | Kosice | |
| Slovakia | Boehringer Ingelheim Investigational Site 160 | Kosice | |
| Slovakia | Boehringer Ingelheim Investigational Site 161 | Kosice | |
| Slovakia | Boehringer Ingelheim Investigational Site 162 | Kosice | |
| Slovakia | Boehringer Ingelheim Investigational Site 163 | Kosice- Saca | |
| Slovakia | Boehringer Ingelheim Investigational Site 164 | Krompachy | |
| Slovakia | Boehringer Ingelheim Investigational Site 165 | Levice | |
| Slovakia | Boehringer Ingelheim Investigational Site 166 | Liptovský Mikulás | |
| Slovakia | Boehringer Ingelheim Investigational Site 167 | Lucenec | |
| Slovakia | Boehringer Ingelheim Investigational Site 168 | Martin | |
| Slovakia | Boehringer Ingelheim Investigational Site 169 | Nitra | |
| Slovakia | Boehringer Ingelheim Investigational Site 170 | Nitra | |
| Slovakia | Boehringer Ingelheim Investigational Site 171 | Nitra | |
| Slovakia | Boehringer Ingelheim Investigational Site 172 | Nováky | |
| Slovakia | Boehringer Ingelheim Investigational Site 173 | Nové Mesto n/ Váhom | |
| Slovakia | Boehringer Ingelheim Investigational Site 174 | Pezinok | |
| Slovakia | Boehringer Ingelheim Investigational Site 175 | Pies?any | |
| Slovakia | Boehringer Ingelheim Investigational Site 176 | Povazská Bystrica | |
| Slovakia | Boehringer Ingelheim Investigational Site 177 | Presov | |
| Slovakia | Boehringer Ingelheim Investigational Site 178 | Presov | |
| Slovakia | Boehringer Ingelheim Investigational Site 179 | Presov | |
| Slovakia | Boehringer Ingelheim Investigational Site 180 | Revúca | |
| Slovakia | Boehringer Ingelheim Investigational Site 181 | Rimavská Sobota | |
| Slovakia | Boehringer Ingelheim Investigational Site 182 | Roznava | |
| Slovakia | Boehringer Ingelheim Investigational Site 183 | Roznava | |
| Slovakia | Boehringer Ingelheim Investigational Site 184 | Sal'a | |
| Slovakia | Boehringer Ingelheim Investigational Site 185 | Sered | |
| Slovakia | Boehringer Ingelheim Investigational Site 186 | Skalica | |
| Slovakia | Boehringer Ingelheim Investigational Site 187 | Stropkov | |
| Slovakia | Boehringer Ingelheim Investigational Site 188 | Surany | |
| Slovakia | Boehringer Ingelheim Investigational Site 189 | Trebisov | |
| Slovakia | Boehringer Ingelheim Investigational Site 190 | Tren?in | |
| Slovakia | Boehringer Ingelheim Investigational Site 191 | Trnava | |
| Slovakia | Boehringer Ingelheim Investigational Site 192 | Trnava | |
| Slovakia | Boehringer Ingelheim Investigational Site 193 | Trstená | |
| Slovakia | Boehringer Ingelheim Investigational Site 194 | Vel'ke Kapusany | |
| Slovakia | Boehringer Ingelheim Investigational Site 195 | Ziar N/Hronom | |
| Slovakia | Boehringer Ingelheim Investigational Site 196 | Zilina | |
| Slovakia | Boehringer Ingelheim Investigational Site 197 | Zilina | |
| Slovakia | Boehringer Ingelheim Investigational Site 198 | Zlaté Moravce | |
| Slovakia | Boehringer Ingelheim Investigational Site 199 | Zvolen | |
| Slovakia | Boehringer Ingelheim Investigational Site 200 | Zvolen | |
| Slovenia | Boehringer Ingelheim Investigational Site 205 | Bled | |
| Slovenia | Boehringer Ingelheim Investigational Site 206 | Celje | |
| Slovenia | Boehringer Ingelheim Investigational Site 201 | Ljubljana | |
| Slovenia | 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 209 | Maribor | |
| Slovenia | Boehringer Ingelheim Investigational Site 210 | Maribor | |
| Slovenia | Boehringer Ingelheim Investigational Site 203 | Sempeter pri Gorici | |
| Slovenia | Boehringer Ingelheim Investigational Site 204 | Sempeter pri Gorici | |
| Ukraine | Boehringer Ingelheim Investigational Site 212 | Kharkiv | |
| Ukraine | Boehringer Ingelheim Investigational Site 211 | Kyiv | |
| Ukraine | Boehringer Ingelheim Investigational Site 215 | Lviv | |
| Ukraine | Boehringer Ingelheim Investigational Site 214 | Ternopil | |
| Ukraine | Boehringer Ingelheim Investigational Site 213 | Vinnitsa |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Estonia, Latvia, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance | 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) | Week 0 to weeks 9-16 (Visit 3) | No |
| Primary | Change From Baseline in UPDRS Part III Score at the End of Maintenance | 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) | Week 0 to weeks 9-16 | No |
| Primary | Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand) | Change (reduction) in tremor amplitude from baseline to end of study for the right hand | Week 0 to weeks 9-16 (Visit 3) | No |
| Primary | Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand) | Change (reduction) in tremor amplitude from baseline to end of study for the left hand | Week 0 to weeks 9-16 (Visit 3) | No |
| Primary | Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3) | Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor) | Week 0 to weeks 9-16 (Visit 3) | No |
| Primary | Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance | 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) | Week 0 to weeks 9-16 (Visit 3) | No |
| Secondary | Final Dose Distribution | Final Mirapexin® dose distribution at the end of study | Enter Week 0 to weeks 9-16 (Visit 3) | No |
| Secondary | Change From Baseline in UPDRS Part II Score at the End of Up-titration | 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) | Enter Week 0 to weeks 1-8 (Visit 2) | No |
| Secondary | Change From Baseline in UPDRS Part III Score at the End of Up-titration | 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) | Enter Week 0 to weeks 1-8 (Visit 2) | No |
| Secondary | Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration | 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) | Enter Week 0 to weeks 1-8 (Visit 2) | No |
| Secondary | Incidence, Relationship and Seriousness of Adverse Events | Total number of adverse events (AEs), causality and level of seriousness | Week 0 to weeks 9-16 (end of study) | No |
| Secondary | Number of Premature Discontinuations | Number of patients discontinuing the study prematurely | Week 0 to weeks 9-16 (end of study) | No |
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