Clinical trial NCT01100073: Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life
Official title: Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-04-08
Enrollment: 1703
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurologists

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.


Eligibility criteria: 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®)

Primary outcomes:
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance
timeFrame: Week 0 to weeks 9-16 (Visit 3)
measure: Change From Baseline in UPDRS Part III Score at the End of Maintenance
timeFrame: Week 0 to weeks 9-16
measure: Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)
timeFrame: Week 0 to weeks 9-16 (Visit 3)
measure: Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)
timeFrame: Week 0 to weeks 9-16 (Visit 3)
measure: Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)
timeFrame: Week 0 to weeks 9-16 (Visit 3)
measure: Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance
timeFrame: Week 0 to weeks 9-16 (Visit 3)
Secondary outcomes:
measure: Final Dose Distribution
timeFrame: Enter Week 0 to weeks 9-16 (Visit 3)
measure: Change From Baseline in UPDRS Part II Score at the End of Up-titration
timeFrame: Enter Week 0 to weeks 1-8 (Visit 2)
measure: Change From Baseline in UPDRS Part III Score at the End of Up-titration
timeFrame: Enter Week 0 to weeks 1-8 (Visit 2)
measure: Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration
timeFrame: Enter Week 0 to weeks 1-8 (Visit 2)
measure: Incidence, Relationship and Seriousness of Adverse Events
timeFrame: Week 0 to weeks 9-16 (end of study)
measure: Number of Premature Discontinuations
timeFrame: Week 0 to weeks 9-16 (end of study)
Other outcomes:
Locations:
city: Keila
country: Estonia
facility: Boehringer Ingelheim Investigational Site 5
city: Kohtla-Järve
country: Estonia
facility: Boehringer Ingelheim Investigational Site 4
city: Rakvere
country: Estonia
facility: Boehringer Ingelheim Investigational Site 6
city: Tallinn
country: Estonia
facility: Boehringer Ingelheim Investigational Site 1
city: Tallinn
country: Estonia
facility: Boehringer Ingelheim Investigational Site 2
city: Tallinn
country: Estonia
facility: Boehringer Ingelheim Investigational Site 3
city: Tartu
country: Estonia
facility: Boehringer Ingelheim Investigational Site 7
city: Valga
country: Estonia
facility: Boehringer Ingelheim Investigational Site 8
city: Kuldiga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 9
city: Liepaja
country: Latvia
facility: Boehringer Ingelheim Investigational Site 12
city: Liepaja
country: Latvia
facility: Boehringer Ingelheim Investigational Site 13
city: Liepaja
country: Latvia
facility: Boehringer Ingelheim Investigational Site 14
city: Liepaja
country: Latvia
facility: Boehringer Ingelheim Investigational Site 15
city: Limbazi
country: Latvia
facility: Boehringer Ingelheim Investigational Site 10
city: Limbazi
country: Latvia
facility: Boehringer Ingelheim Investigational Site 11
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 16
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 17
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 18
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 19
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 20
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 21
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 22
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 23
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 24
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 25
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 26
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 27
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 28
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 29
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 30
city: Riga
country: Latvia
facility: Boehringer Ingelheim Investigational Site 31
city: Aiud
country: Romania
facility: Boehringer Ingelheim Investigational Site 32
city: Arges
country: Romania
facility: Boehringer Ingelheim Investigational Site 33
city: Arges
country: Romania
facility: Boehringer Ingelheim Investigational Site 34
city: Arges
country: Romania
facility: Boehringer Ingelheim Investigational Site 35
city: Arges
country: Romania
facility: Boehringer Ingelheim Investigational Site 36
city: Arges
country: Romania
facility: Boehringer Ingelheim Investigational Site 37
city: Arges
country: Romania
facility: Boehringer Ingelheim Investigational Site 38
city: Arges
country: Romania
facility: Boehringer Ingelheim Investigational Site 39
city: Bacau
country: Romania
facility: Boehringer Ingelheim Investigational Site 40
city: Bacau
country: Romania
facility: Boehringer Ingelheim Investigational Site 41
city: Bistrita
country: Romania
facility: Boehringer Ingelheim Investigational Site 42
city: Botosani
country: Romania
facility: Boehringer Ingelheim Investigational Site 43
city: Botosani
country: Romania
facility: Boehringer Ingelheim Investigational Site 44
city: Braila
country: Romania
facility: Boehringer Ingelheim Investigational Site 45
city: Braila
country: Romania
facility: Boehringer Ingelheim Investigational Site 46
city: Brasov
country: Romania
facility: Boehringer Ingelheim Investigational Site 47
city: Brasov
country: Romania
facility: Boehringer Ingelheim Investigational Site 48
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 49
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 50
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 51
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 52
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 53
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 54
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 55
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 56
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 57
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 58
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 59
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 60
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 61
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 62
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 63
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 64
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 65
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 66
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 67
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 68
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 69
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 70
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 71
city: Buzau
country: Romania
facility: Boehringer Ingelheim Investigational Site 72
city: Buzau
country: Romania
facility: Boehringer Ingelheim Investigational Site 73
city: Caracal
country: Romania
facility: Boehringer Ingelheim Investigational Site 74
city: Cluj
country: Romania
facility: Boehringer Ingelheim Investigational Site 75
city: Cluj
country: Romania
facility: Boehringer Ingelheim Investigational Site 76
city: Cluj
country: Romania
facility: Boehringer Ingelheim Investigational Site 77
city: Cluj
country: Romania
facility: Boehringer Ingelheim Investigational Site 78
city: Cluj
country: Romania
facility: Boehringer Ingelheim Investigational Site 79
city: Cluj
country: Romania
facility: Boehringer Ingelheim Investigational Site 80
city: Constanta
country: Romania
facility: Boehringer Ingelheim Investigational Site 81
city: Constanta
country: Romania
facility: Boehringer Ingelheim Investigational Site 82
city: Craiova
country: Romania
facility: Boehringer Ingelheim Investigational Site 83
city: Craiova
country: Romania
facility: Boehringer Ingelheim Investigational Site 84
city: Craiova
country: Romania
facility: Boehringer Ingelheim Investigational Site 85
city: Craiova
country: Romania
facility: Boehringer Ingelheim Investigational Site 86
city: Deva
country: Romania
facility: Boehringer Ingelheim Investigational Site 87
city: Deva
country: Romania
facility: Boehringer Ingelheim Investigational Site 88
city: Focsani
country: Romania
facility: Boehringer Ingelheim Investigational Site 89
city: Focsani
country: Romania
facility: Boehringer Ingelheim Investigational Site 90
city: Galati
country: Romania
facility: Boehringer Ingelheim Investigational Site 91
city: Galati
country: Romania
facility: Boehringer Ingelheim Investigational Site 92
city: Hunedoara
country: Romania
facility: Boehringer Ingelheim Investigational Site 93
city: Hunedoara
country: Romania
facility: Boehringer Ingelheim Investigational Site 94
city: Iasi
country: Romania
facility: Boehringer Ingelheim Investigational Site 95
city: Iasi
country: Romania
facility: Boehringer Ingelheim Investigational Site 96
city: Iasi
country: Romania
facility: Boehringer Ingelheim Investigational Site 97
city: Iasi
country: Romania
facility: Boehringer Ingelheim Investigational Site 98
city: Lugoj
country: Romania
facility: Boehringer Ingelheim Investigational Site 99
city: Maramures
country: Romania
facility: Boehringer Ingelheim Investigational Site 100
city: Orastie
country: Romania
facility: Boehringer Ingelheim Investigational Site 101
city: Pascani
country: Romania
facility: Boehringer Ingelheim Investigational Site 102
city: Pascani
country: Romania
facility: Boehringer Ingelheim Investigational Site 103
city: Petrosani
country: Romania
facility: Boehringer Ingelheim Investigational Site 104
city: Piatra Neamt
country: Romania
facility: Boehringer Ingelheim Investigational Site 105
city: Prahova
country: Romania
facility: Boehringer Ingelheim Investigational Site 106
city: Prahova
country: Romania
facility: Boehringer Ingelheim Investigational Site 107
city: Prahova
country: Romania
facility: Boehringer Ingelheim Investigational Site 108
city: Radauti
country: Romania
facility: Boehringer Ingelheim Investigational Site 109
city: Resita
country: Romania
facility: Boehringer Ingelheim Investigational Site 110
city: Satu Mare
country: Romania
facility: Boehringer Ingelheim Investigational Site 111
city: Sibiu
country: Romania
facility: Boehringer Ingelheim Investigational Site 112
city: Sibiu
country: Romania
facility: Boehringer Ingelheim Investigational Site 113
city: Slatina
country: Romania
facility: Boehringer Ingelheim Investigational Site 114
city: Suceava
country: Romania
facility: Boehringer Ingelheim Investigational Site 115
city: Suceava
country: Romania
facility: Boehringer Ingelheim Investigational Site 116
city: Teleorman
country: Romania
facility: Boehringer Ingelheim Investigational Site 117
city: Tg. Mures
country: Romania
facility: Boehringer Ingelheim Investigational Site 118
city: Timisoara
country: Romania
facility: Boehringer Ingelheim Investigational Site 119
city: Timisoara
country: Romania
facility: Boehringer Ingelheim Investigational Site 120
city: Timisoara
country: Romania
facility: Boehringer Ingelheim Investigational Site 121
city: Timisoara
country: Romania
facility: Boehringer Ingelheim Investigational Site 122
city: Tulcea
country: Romania
facility: Boehringer Ingelheim Investigational Site 123
city: Tulcea
country: Romania
facility: Boehringer Ingelheim Investigational Site 124
city: Krasnodar
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site 131
city: Krasnoyarsk
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site 130
city: Moscow
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site 125
city: Moscow
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site 126
city: Moscow
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site 127
city: Novosibirsk
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site 128
city: Saint-Petersburg
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site 132
city: Saint-Petersburg
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site 133
city: Saint-Petersburg
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site 134
city: Tomsk
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site 129
city: Belgrade
country: Serbia
facility: Boehringer Ingelheim Investigational Site 135
city: Belgrade
country: Serbia
facility: Boehringer Ingelheim Investigational Site 136
city: Kragujevac
country: Serbia
facility: Boehringer Ingelheim Investigational Site 140
city: Krusevac
country: Serbia
facility: Boehringer Ingelheim Investigational Site 138
city: Nis
country: Serbia
facility: Boehringer Ingelheim Investigational Site 141
city: Nis
country: Serbia
facility: Boehringer Ingelheim Investigational Site 142
city: Novi Sad
country: Serbia
facility: Boehringer Ingelheim Investigational Site 137
city: Sombor
country: Serbia
facility: Boehringer Ingelheim Investigational Site 143
city: Uzice
country: Serbia
facility: Boehringer Ingelheim Investigational Site 145
city: Valjevo
country: Serbia
facility: Boehringer Ingelheim Investigational Site 139
city: Vranje
country: Serbia
facility: Boehringer Ingelheim Investigational Site 144
city: ?adca
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 155
city: Banská Bystrica
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 146
city: Bardejov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 147
city: Bratislava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 148
city: Bratislava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 149
city: Bratislava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 150
city: Bratislava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 151
city: Bratislava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 152
city: Bratislava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 153
city: Brezno
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 154
city: Humenné
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 156
city: Ilava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 157
city: Komárno
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 158
city: Kosice- Saca
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 163
city: Kosice
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 159
city: Kosice
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 160
city: Kosice
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 161
city: Kosice
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 162
city: Krompachy
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 164
city: Levice
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 165
city: Liptovský Mikulás
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 166
city: Lucenec
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 167
city: Martin
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 168
city: Nitra
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 169
city: Nitra
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 170
city: Nitra
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 171
city: Nováky
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 172
city: Nové Mesto n/ Váhom
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 173
city: Pezinok
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 174
city: Pies?any
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 175
city: Povazská Bystrica
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 176
city: Presov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 177
city: Presov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 178
city: Presov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 179
city: Revúca
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 180
city: Rimavská Sobota
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 181
city: Roznava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 182
city: Roznava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 183
city: Sal'a
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 184
city: Sered
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 185
city: Skalica
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 186
city: Stropkov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 187
city: Surany
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 188
city: Trebisov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 189
city: Tren?in
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 190
city: Trnava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 191
city: Trnava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 192
city: Trstená
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 193
city: Vel'ke Kapusany
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 194
city: Ziar N/Hronom
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 195
city: Zilina
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 196
city: Zilina
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 197
city: Zlaté Moravce
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 198
city: Zvolen
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 199
city: Zvolen
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 200
city: Bled
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 205
city: Celje
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 206
city: Ljubljana
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 201
city: Ljubljana
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 202
city: Maribor
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 207
city: Maribor
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 208
city: Maribor
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 209
city: Maribor
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 210
city: Sempeter pri Gorici
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 203
city: Sempeter pri Gorici
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 204
city: Kharkiv
country: Ukraine
facility: Boehringer Ingelheim Investigational Site 212
city: Kyiv
country: Ukraine
facility: Boehringer Ingelheim Investigational Site 211
city: Lviv
country: Ukraine
facility: Boehringer Ingelheim Investigational Site 215
city: Ternopil
country: Ukraine
facility: Boehringer Ingelheim Investigational Site 214
city: Vinnitsa
country: Ukraine
facility: Boehringer Ingelheim Investigational Site 213
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: