Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa

NCT00613301 | Completed Results

• 1 other identifier: 248.549
• Study Type: observational
• Target: 416
• Locations: 1 country
• Sites: 119

Brief Summary

The survey is conducted to collect safety and effectiveness information in Parkinson's Disease patients treated with Pramipexole without concomitant L-Dopa supplementation in the daily clinical settings in Japan.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events

  The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.

  during 36 months

Secondary Outcomes (3)

• Clinical Global Impression of Improvement

  after 36 months treatment

• Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score

  Baseline and at 36 months (or at the time of discontinuation)

• Change From Baseline in Modified Hoehn & Yahr Rating Scale

  Baseline and at 36 months (or at the time of discontinuation)

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

Parkinson's disease patients in daily clinical settings

You may qualify if:

• Patients with Parkinson's disease who do not receive L-Dopa supplementation

You may not qualify if:

• Patients should have been treated according to the Japanese insert slip

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (119)

Boehringer Ingelheim Investigational Site 11

Akita, Japan

Location

Boehringer Ingelheim Investigational Site 95

Anan, Japan

Location

Boehringer Ingelheim Investigational Site 1

Asahikawa, Japan

Location

Boehringer Ingelheim Investigational Site 2

Asahikawa, Japan

Location

Boehringer Ingelheim Investigational Site 26

Chiba, Japan

Location

Boehringer Ingelheim Investigational Site 27

Chiba, Japan

Location

Boehringer Ingelheim Investigational Site 60

Fuji, Japan

Location

Boehringer Ingelheim Investigational Site 49

Fujisawa, Japan

Location

Boehringer Ingelheim Investigational Site 25

Fukaya, Japan

Location

Boehringer Ingelheim Investigational Site 103

Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site 104

Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site 105

Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site 106

Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site 56

Gifu, Japan

Location

Boehringer Ingelheim Investigational Site 80

Habikino, Japan

Location

Boehringer Ingelheim Investigational Site 3

Hakodate, Japan

Location

Boehringer Ingelheim Investigational Site 59

Hamamatsu, Japan

Location

Boehringer Ingelheim Investigational Site 64

Handa, Japan

Location

Boehringer Ingelheim Investigational Site 82

Himeji, Japan

Location

Boehringer Ingelheim Investigational Site 76

Hirakata, Japan

Location

Boehringer Ingelheim Investigational Site 86

Hiroshima, Japan

Location

Boehringer Ingelheim Investigational Site 87

Hiroshima, Japan

Location

Boehringer Ingelheim Investigational Site 8

Ichinoseki, Japan

Location

Boehringer Ingelheim Investigational Site 118

Kagoshima, Japan

Location

Boehringer Ingelheim Investigational Site 15

Kamisu, Japan

Location

Boehringer Ingelheim Investigational Site 50

Kashiwazaki, Japan

Location

Boehringer Ingelheim Investigational Site 107

Kasuga, Japan

Location

Boehringer Ingelheim Investigational Site 24

Kawagoe, Japan

Location

Boehringer Ingelheim Investigational Site 46

Kawasaki, Japan

Location

Boehringer Ingelheim Investigational Site 111

Kawatana, Japan

Location

Boehringer Ingelheim Investigational Site 112

Kawatana, Japan

Location

Boehringer Ingelheim Investigational Site 99

Kitakyushu, Japan

Location

Boehringer Ingelheim Investigational Site 117

Kiyotake, Japan

Location

Boehringer Ingelheim Investigational Site 83

Kobe, Japan

Location

Boehringer Ingelheim Investigational Site 67

Koga, Japan

Location

Boehringer Ingelheim Investigational Site 21

Koshiagya, Japan

Location

Boehringer Ingelheim Investigational Site 63

Kōnan, Japan

Location

Boehringer Ingelheim Investigational Site 12

Kōriyama, Japan

Location

Boehringer Ingelheim Investigational Site 13

Kōriyama, Japan

Location

Boehringer Ingelheim Investigational Site 100

Kurume, Japan

Location

Boehringer Ingelheim Investigational Site 68

Kyoto, Japan

Location

Boehringer Ingelheim Investigational Site 69

Kyoto, Japan

Location

Boehringer Ingelheim Investigational Site 70

Kyoto, Japan

Location

Boehringer Ingelheim Investigational Site 71

Kyoto, Japan

Location

Boehringer Ingelheim Investigational Site 19

Maebashi, Japan

Location

Boehringer Ingelheim Investigational Site 20

Maebashi, Japan

Location

Boehringer Ingelheim Investigational Site 55

Matsumoto, Japan

Location

Boehringer Ingelheim Investigational Site 88

Mihara, Japan

Location

Boehringer Ingelheim Investigational Site 54

Minobu, Japan

Location

Boehringer Ingelheim Investigational Site 116

Miyakonojō, Japan

Location

Boehringer Ingelheim Investigational Site 114

Miyazaki, Japan

Location

Boehringer Ingelheim Investigational Site 115

Miyazaki, Japan

Location

Boehringer Ingelheim Investigational Site 77

Moriguchi, Japan

Location

Boehringer Ingelheim Investigational Site 9

Morioka, Japan

Location

Boehringer Ingelheim Investigational Site 23

Morohongō, Japan

Location

Boehringer Ingelheim Investigational Site 53

Mukai-awagasaki, Japan

Location

Boehringer Ingelheim Investigational Site 4

Muroran, Japan

Location

Boehringer Ingelheim Investigational Site 51

Nagaoka, Japan

Location

Boehringer Ingelheim Investigational Site 61

Nagoya, Japan

Location

Boehringer Ingelheim Investigational Site 62

Nagoya, Japan

Location

Boehringer Ingelheim Investigational Site 97

Nangōku, Japan

Location

Boehringer Ingelheim Investigational Site 102

Naoetsu, Japan

Location

Boehringer Ingelheim Investigational Site 28

Narita, Japan

Location

Boehringer Ingelheim Investigational Site 93

Narutō, Japan

Location

Boehringer Ingelheim Investigational Site 17

Nikkō, Japan

Location

Boehringer Ingelheim Investigational Site 119

Nishihara, Japan

Location

Boehringer Ingelheim Investigational Site 81

Nishinomiya, Japan

Location

Boehringer Ingelheim Investigational Site 72

Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 98

Ōkawa, Japan

Location

Boehringer Ingelheim Investigational Site 66

Ōtsu, Japan

Location

Boehringer Ingelheim Investigational Site 108

Saga, Japan

Location

Boehringer Ingelheim Investigational Site 45

Sagamihara, Japan

Location

Boehringer Ingelheim Investigational Site 22

Saitama, Japan

Location

Boehringer Ingelheim Investigational Site 79

Sakai, Japan

Location

Boehringer Ingelheim Investigational Site 52

Sanjō, Japan

Location

Boehringer Ingelheim Investigational Site 90

Sanyōonoda, Japan

Location

Boehringer Ingelheim Investigational Site 5

Sapporo, Japan

Location

Boehringer Ingelheim Investigational Site 6

Sapporo, Japan

Location

Boehringer Ingelheim Investigational Site 7

Sapporo, Japan

Location

Boehringer Ingelheim Investigational Site 110

Sasebo, Japan

Location

Boehringer Ingelheim Investigational Site 78

Sayama, Japan

Location

Boehringer Ingelheim Investigational Site 10

Sendai, Japan

Location

Boehringer Ingelheim Investigational Site 91

Shimonoseki, Japan

Location

Boehringer Ingelheim Investigational Site 18

Shimotsuke, Japan

Location

Boehringer Ingelheim Investigational Site 85

Shingū, Japan

Location

Boehringer Ingelheim Investigational Site 57

Shizuoka, Japan

Location

Boehringer Ingelheim Investigational Site 58

Shizuoka, Japan

Location

Boehringer Ingelheim Investigational Site 73

Suita, Japan

Location

Boehringer Ingelheim Investigational Site 101

Tagawa, Japan

Location

Boehringer Ingelheim Investigational Site 96

Takamatsu, Japan

Location

Boehringer Ingelheim Investigational Site 74

Takatsuki, Japan

Location

Boehringer Ingelheim Investigational Site 75

Takatsuki, Japan

Location

Boehringer Ingelheim Investigational Site 109

Togitsu, Japan

Location

Boehringer Ingelheim Investigational Site 92

Tokushima, Japan

Location

Boehringer Ingelheim Investigational Site 30

Tokyo Adachi-ku, Japan

Location

Boehringer Ingelheim Investigational Site 31

Tokyo Arakawa-ku, Japan

Location

Boehringer Ingelheim Investigational Site 40

Tokyo Bunkyo-ku, Japan

Location

Boehringer Ingelheim Investigational Site 41

Tokyo Bunkyo-ku, Japan

Location

Boehringer Ingelheim Investigational Site 42

Tokyo Bunkyo-ku, Japan

Location

Boehringer Ingelheim Investigational Site 38

Tokyo Chiyoda-ku, Japan

Location

Boehringer Ingelheim Investigational Site 32

Tokyo Itabashi-ku, Japan

Location

Boehringer Ingelheim Investigational Site 33

Tokyo Itabashi-ku, Japan

Location

Boehringer Ingelheim Investigational Site 43

Tokyo Meguro-ku, Japan

Location

Boehringer Ingelheim Investigational Site 39

Tokyo Nakano-ku, Japan

Location

Boehringer Ingelheim Investigational Site 34

Tokyo Ota-ku, Japan

Location

Boehringer Ingelheim Investigational Site 35

Tokyo Ota-ku, Japan

Location

Boehringer Ingelheim Investigational Site 36

Tokyo Shinjuku-ku, Japan

Location

Boehringer Ingelheim Investigational Site 37

Tokyo Shinjuku-ku, Japan

Location

Boehringer Ingelheim Investigational Site 44

Tokyo Toshima-ku, Japan

Location

Boehringer Ingelheim Investigational Site 113

Tomiai, Japan

Location

Boehringer Ingelheim Investigational Site 14

Toride, Japan

Location

Boehringer Ingelheim Investigational Site 65

Tsu, Japan

Location

Boehringer Ingelheim Investigational Site 16

Tsukuba, Japan

Location

Boehringer Ingelheim Investigational Site 29

Urayasu, Japan

Location

Boehringer Ingelheim Investigational Site 84

Wakayama, Japan

Location

Boehringer Ingelheim Investigational Site 89

Yamaguchi, Japan

Location

Boehringer Ingelheim Investigational Site 47

Yokohama, Japan

Location

Boehringer Ingelheim Investigational Site 48

Yokohama, Japan

Location

Boehringer Ingelheim Investigational Site 94

Yoshinogawa, Japan

Location

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: January 31, 2008
• First Posted: February 13, 2008
• Study Start: February 1, 2004
• Primary Completion: September 1, 2009
• Last Updated: June 6, 2014
• Results First Posted: November 23, 2010

Record last verified: 2014-05

Locations

JP (119)