Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life

NCT01100073 | Completed Results

• 1 other identifier: 248.657
• Study Type: observational
• Target: 1,703
• Locations: 7 countries
• Sites: 205

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (6)

• 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)

• 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

• 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)

• 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)

• 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)

• 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)

Secondary Outcomes (6)

• Final Dose Distribution

  Enter Week 0 to weeks 9-16 (Visit 3)

• Change From Baseline in UPDRS Part II Score at the End of Up-titration

  Enter Week 0 to weeks 1-8 (Visit 2)

• Change From Baseline in UPDRS Part III Score at the End of Up-titration

  Enter Week 0 to weeks 1-8 (Visit 2)

• Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration

  Enter Week 0 to weeks 1-8 (Visit 2)

• Incidence, Relationship and Seriousness of Adverse Events

  Week 0 to weeks 9-16 (end of study)

Study Arms (1)

Patients with Parkinson's disease

Early and advanced Parkinson's disease patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neurologists

You may qualify if:

• 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)

You may not qualify if:

• Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
• Ongoing treatment with pramipexole (Mirapexin®)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (215)

Boehringer Ingelheim Investigational Site 5

Keila, Estonia

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Boehringer Ingelheim Investigational Site 4

Kohtla-Järve, Estonia

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Boehringer Ingelheim Investigational Site 6

Rakvere, Estonia

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Boehringer Ingelheim Investigational Site 1

Tallinn, Estonia

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Boehringer Ingelheim Investigational Site 2

Tallinn, Estonia

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Boehringer Ingelheim Investigational Site 3

Tallinn, Estonia

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Boehringer Ingelheim Investigational Site 7

Tartu, Estonia

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Boehringer Ingelheim Investigational Site 8

Valga, Estonia

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Boehringer Ingelheim Investigational Site 9

Kuldīga, Latvia

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Boehringer Ingelheim Investigational Site 12

Liepāja, Latvia

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Boehringer Ingelheim Investigational Site 13

Liepāja, Latvia

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Boehringer Ingelheim Investigational Site 14

Liepāja, Latvia

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Boehringer Ingelheim Investigational Site 15

Liepāja, Latvia

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Boehringer Ingelheim Investigational Site 10

Limbaži, Latvia

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Boehringer Ingelheim Investigational Site 11

Limbaži, Latvia

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Boehringer Ingelheim Investigational Site 16

Riga, Latvia

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Boehringer Ingelheim Investigational Site 17

Riga, Latvia

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Boehringer Ingelheim Investigational Site 18

Riga, Latvia

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Boehringer Ingelheim Investigational Site 19

Riga, Latvia

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Boehringer Ingelheim Investigational Site 20

Riga, Latvia

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Boehringer Ingelheim Investigational Site 21

Riga, Latvia

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Boehringer Ingelheim Investigational Site 22

Riga, Latvia

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Boehringer Ingelheim Investigational Site 23

Riga, Latvia

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Boehringer Ingelheim Investigational Site 24

Riga, Latvia

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Boehringer Ingelheim Investigational Site 25

Riga, Latvia

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Boehringer Ingelheim Investigational Site 26

Riga, Latvia

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Boehringer Ingelheim Investigational Site 27

Riga, Latvia

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Boehringer Ingelheim Investigational Site 28

Riga, Latvia

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Boehringer Ingelheim Investigational Site 29

Riga, Latvia

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Boehringer Ingelheim Investigational Site 30

Riga, Latvia

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Boehringer Ingelheim Investigational Site 31

Riga, Latvia

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Boehringer Ingelheim Investigational Site 32

Aiud, Romania

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Boehringer Ingelheim Investigational Site 33

Arges, Romania

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Boehringer Ingelheim Investigational Site 34

Arges, Romania

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Boehringer Ingelheim Investigational Site 35

Arges, Romania

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Boehringer Ingelheim Investigational Site 36

Arges, Romania

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Boehringer Ingelheim Investigational Site 37

Arges, Romania

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Boehringer Ingelheim Investigational Site 38

Arges, Romania

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Boehringer Ingelheim Investigational Site 39

Arges, Romania

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Boehringer Ingelheim Investigational Site 40

Bacau, Romania

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Boehringer Ingelheim Investigational Site 41

Bacau, Romania

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Boehringer Ingelheim Investigational Site 42

Bistriţa, Romania

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Boehringer Ingelheim Investigational Site 43

Botoșani, Romania

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Boehringer Ingelheim Investigational Site 44

Botoșani, Romania

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Boehringer Ingelheim Investigational Site 47

Brasov, Romania

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Boehringer Ingelheim Investigational Site 48

Brasov, Romania

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Boehringer Ingelheim Investigational Site 45

Brăila, Romania

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Boehringer Ingelheim Investigational Site 46

Brăila, Romania

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Boehringer Ingelheim Investigational Site 49

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 50

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 51

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 52

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 53

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 54

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 55

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 56

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 57

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 58

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 59

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 60

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 61

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 62

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 63

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 64

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 65

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 66

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 67

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 68

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 69

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 70

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 71

Bucharest, Romania

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Boehringer Ingelheim Investigational Site 72

Buzău, Romania

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Boehringer Ingelheim Investigational Site 73

Buzău, Romania

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Boehringer Ingelheim Investigational Site 74

Caracal, Romania

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Boehringer Ingelheim Investigational Site 75

Cluj-Napoca, Romania

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Boehringer Ingelheim Investigational Site 76

Cluj-Napoca, Romania

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Boehringer Ingelheim Investigational Site 77

Cluj-Napoca, Romania

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Boehringer Ingelheim Investigational Site 78

Cluj-Napoca, Romania

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Boehringer Ingelheim Investigational Site 79

Cluj-Napoca, Romania

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Boehringer Ingelheim Investigational Site 80

Cluj-Napoca, Romania

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Boehringer Ingelheim Investigational Site 81

Constanța, Romania

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Boehringer Ingelheim Investigational Site 82

Constanța, Romania

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Boehringer Ingelheim Investigational Site 83

Craiova, Romania

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Boehringer Ingelheim Investigational Site 84

Craiova, Romania

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Boehringer Ingelheim Investigational Site 85

Craiova, Romania

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Boehringer Ingelheim Investigational Site 86

Craiova, Romania

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Boehringer Ingelheim Investigational Site 87

Deva, Romania

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Boehringer Ingelheim Investigational Site 88

Deva, Romania

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Boehringer Ingelheim Investigational Site 89

Focşani, Romania

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Boehringer Ingelheim Investigational Site 90

Focşani, Romania

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Boehringer Ingelheim Investigational Site 91

Galati, Romania

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Boehringer Ingelheim Investigational Site 92

Galati, Romania

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Boehringer Ingelheim Investigational Site 93

Hunedoara, Romania

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Boehringer Ingelheim Investigational Site 94

Hunedoara, Romania

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Boehringer Ingelheim Investigational Site 95

Iași, Romania

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Boehringer Ingelheim Investigational Site 96

Iași, Romania

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Boehringer Ingelheim Investigational Site 97

Iași, Romania

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Boehringer Ingelheim Investigational Site 98

Iași, Romania

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Boehringer Ingelheim Investigational Site 99

Lugoj, Romania

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Boehringer Ingelheim Investigational Site 100

Maramures, Romania

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Boehringer Ingelheim Investigational Site 101

Orăştie, Romania

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Boehringer Ingelheim Investigational Site 102

Paşcani, Romania

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Boehringer Ingelheim Investigational Site 103

Paşcani, Romania

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Boehringer Ingelheim Investigational Site 104

Petroşani, Romania

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Boehringer Ingelheim Investigational Site 105

Piatra Neamţ, Romania

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Boehringer Ingelheim Investigational Site 106

Prahova, Romania

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Boehringer Ingelheim Investigational Site 107

Prahova, Romania

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Boehringer Ingelheim Investigational Site 108

Prahova, Romania

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Boehringer Ingelheim Investigational Site 109

Radauti, Romania

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Boehringer Ingelheim Investigational Site 110

Reşiţa, Romania

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Boehringer Ingelheim Investigational Site 111

Satu Mare, Romania

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Boehringer Ingelheim Investigational Site 112

Sibiu, Romania

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Boehringer Ingelheim Investigational Site 113

Sibiu, Romania

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Boehringer Ingelheim Investigational Site 114

Slatina, Romania

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Boehringer Ingelheim Investigational Site 115

Suceava, Romania

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Boehringer Ingelheim Investigational Site 116

Suceava, Romania

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Boehringer Ingelheim Investigational Site 117

Teleorman, Romania

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Boehringer Ingelheim Investigational Site 118

Tg. Mures, Romania

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Boehringer Ingelheim Investigational Site 119

Timișoara, Romania

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Boehringer Ingelheim Investigational Site 120

Timișoara, Romania

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Boehringer Ingelheim Investigational Site 121

Timișoara, Romania

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Boehringer Ingelheim Investigational Site 122

Timișoara, Romania

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Boehringer Ingelheim Investigational Site 123

Tulcea, Romania

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Boehringer Ingelheim Investigational Site 124

Tulcea, Romania

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Boehringer Ingelheim Investigational Site 131

Krasnodar, Russia

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Boehringer Ingelheim Investigational Site 130

Krasnoyarsk, Russia

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Boehringer Ingelheim Investigational Site 125

Moscow, Russia

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Boehringer Ingelheim Investigational Site 126

Moscow, Russia

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Boehringer Ingelheim Investigational Site 127

Moscow, Russia

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Boehringer Ingelheim Investigational Site 128

Novosibirsk, Russia

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Boehringer Ingelheim Investigational Site 132

Saint Petersburg, Russia

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Boehringer Ingelheim Investigational Site 133

Saint Petersburg, Russia

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Boehringer Ingelheim Investigational Site 134

Saint Petersburg, Russia

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Boehringer Ingelheim Investigational Site 129

Tomsk, Russia

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Boehringer Ingelheim Investigational Site 135

Belgrade, Serbia

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Boehringer Ingelheim Investigational Site 136

Belgrade, Serbia

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Boehringer Ingelheim Investigational Site 140

Kragujevac, Serbia

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Boehringer Ingelheim Investigational Site 138

Kruševac, Serbia

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Boehringer Ingelheim Investigational Site 141

Niš, Serbia

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Boehringer Ingelheim Investigational Site 142

Niš, Serbia

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Boehringer Ingelheim Investigational Site 137

Novi Sad, Serbia

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Boehringer Ingelheim Investigational Site 143

Sombor, Serbia

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Boehringer Ingelheim Investigational Site 145

Užice, Serbia

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Boehringer Ingelheim Investigational Site 139

Valjevo, Serbia

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Boehringer Ingelheim Investigational Site 144

Vranje, Serbia

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Boehringer Ingelheim Investigational Site 155

?adca, Slovakia

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Boehringer Ingelheim Investigational Site 146

Banská Bystrica, Slovakia

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Boehringer Ingelheim Investigational Site 147

Bardejov, Slovakia

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Boehringer Ingelheim Investigational Site 148

Bratislava, Slovakia

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Boehringer Ingelheim Investigational Site 149

Bratislava, Slovakia

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Boehringer Ingelheim Investigational Site 150

Bratislava, Slovakia

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Boehringer Ingelheim Investigational Site 151

Bratislava, Slovakia

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Boehringer Ingelheim Investigational Site 152

Bratislava, Slovakia

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Boehringer Ingelheim Investigational Site 153

Bratislava, Slovakia

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Boehringer Ingelheim Investigational Site 154

Brezno, Slovakia

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Boehringer Ingelheim Investigational Site 156

Humenné, Slovakia

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Boehringer Ingelheim Investigational Site 157

Ilava, Slovakia

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Boehringer Ingelheim Investigational Site 158

Komárno, Slovakia

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Boehringer Ingelheim Investigational Site 163

Kosice- Saca, Slovakia

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Boehringer Ingelheim Investigational Site 159

Košice, Slovakia

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Boehringer Ingelheim Investigational Site 160

Košice, Slovakia

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Boehringer Ingelheim Investigational Site 161

Košice, Slovakia

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Boehringer Ingelheim Investigational Site 162

Košice, Slovakia

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Boehringer Ingelheim Investigational Site 164

Krompachy, Slovakia

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Boehringer Ingelheim Investigational Site 165

Levice, Slovakia

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Boehringer Ingelheim Investigational Site 166

Liptovský Mikulás, Slovakia

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Boehringer Ingelheim Investigational Site 167

Lučenec, Slovakia

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Boehringer Ingelheim Investigational Site 168

Martin, Slovakia

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Boehringer Ingelheim Investigational Site 169

Nitra, Slovakia

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Boehringer Ingelheim Investigational Site 170

Nitra, Slovakia

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Boehringer Ingelheim Investigational Site 171

Nitra, Slovakia

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Boehringer Ingelheim Investigational Site 172

Nováky, Slovakia

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Boehringer Ingelheim Investigational Site 173

Nové Mesto N/ Váhom, Slovakia

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Boehringer Ingelheim Investigational Site 174

Pezinok, Slovakia

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Boehringer Ingelheim Investigational Site 175

Pies?any, Slovakia

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Boehringer Ingelheim Investigational Site 176

Povazská Bystrica, Slovakia

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Boehringer Ingelheim Investigational Site 177

Prešov, Slovakia

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Boehringer Ingelheim Investigational Site 178

Prešov, Slovakia

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Boehringer Ingelheim Investigational Site 179

Prešov, Slovakia

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Boehringer Ingelheim Investigational Site 180

Revúca, Slovakia

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Boehringer Ingelheim Investigational Site 181

Rimavská Sobota, Slovakia

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Boehringer Ingelheim Investigational Site 182

Rožňava, Slovakia

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Boehringer Ingelheim Investigational Site 183

Rožňava, Slovakia

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Boehringer Ingelheim Investigational Site 185

Sereď, Slovakia

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Boehringer Ingelheim Investigational Site 186

Skalica, Slovakia

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Boehringer Ingelheim Investigational Site 187

Stropkov, Slovakia

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Boehringer Ingelheim Investigational Site 184

Šaľa, Slovakia

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Boehringer Ingelheim Investigational Site 188

Šurany, Slovakia

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Boehringer Ingelheim Investigational Site 189

Trebišov, Slovakia

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Boehringer Ingelheim Investigational Site 190

Tren?in, Slovakia

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Boehringer Ingelheim Investigational Site 191

Trnava, Slovakia

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Boehringer Ingelheim Investigational Site 192

Trnava, Slovakia

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Boehringer Ingelheim Investigational Site 193

Trstená, Slovakia

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Boehringer Ingelheim Investigational Site 194

Veľké Kapušany, Slovakia

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Boehringer Ingelheim Investigational Site 195

Ziar N/Hronom, Slovakia

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Boehringer Ingelheim Investigational Site 198

Zlaté Moravce, Slovakia

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Boehringer Ingelheim Investigational Site 199

Zvolen, Slovakia

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Boehringer Ingelheim Investigational Site 200

Zvolen, Slovakia

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Boehringer Ingelheim Investigational Site 196

Žilina, Slovakia

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Boehringer Ingelheim Investigational Site 197

Žilina, Slovakia

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Boehringer Ingelheim Investigational Site 205

Bled, Slovenia

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Boehringer Ingelheim Investigational Site 206

Celje, Slovenia

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Boehringer Ingelheim Investigational Site 201

Ljubljana, Slovenia

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Boehringer Ingelheim Investigational Site 202

Ljubljana, Slovenia

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Boehringer Ingelheim Investigational Site 207

Maribor, Slovenia

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Boehringer Ingelheim Investigational Site 208

Maribor, Slovenia

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Boehringer Ingelheim Investigational Site 209

Maribor, Slovenia

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Boehringer Ingelheim Investigational Site 210

Maribor, Slovenia

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Boehringer Ingelheim Investigational Site 203

Šempeter pri Gorici, Slovenia

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Boehringer Ingelheim Investigational Site 204

Šempeter pri Gorici, Slovenia

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Boehringer Ingelheim Investigational Site 212

Kharkiv, Ukraine

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Boehringer Ingelheim Investigational Site 211

Kyiv, Ukraine

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Boehringer Ingelheim Investigational Site 215

Lviv, Ukraine

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Boehringer Ingelheim Investigational Site 214

Ternopil, Ukraine

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Boehringer Ingelheim Investigational Site 213

Vinnitsa, Ukraine

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MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: April 8, 2010
• Study Start: February 1, 2008
• Primary Completion: August 1, 2009
• Last Updated: April 11, 2014
• Results First Posted: September 20, 2010

Record last verified: 2014-03

Locations

RO (93); RU (10); SL (55); LA (23); SE (11); ES (8); UA (5)