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

May 28, 2014 updated by: Boehringer Ingelheim

Pramipexole Special Survey on Patients Without Concomitant Use of L-Dopa

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

416

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Akita, Japan
        • Boehringer Ingelheim Investigational Site 11
      • Anan, Japan
        • Boehringer Ingelheim Investigational Site 95
      • Asahikawa, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Asahikawa, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Chiba, Japan
        • Boehringer Ingelheim Investigational Site 26
      • Chiba, Japan
        • Boehringer Ingelheim Investigational Site 27
      • Fuji, Japan
        • Boehringer Ingelheim Investigational Site 60
      • Fujisawa, Japan
        • Boehringer Ingelheim Investigational Site 49
      • Fukaya, Japan
        • Boehringer Ingelheim Investigational Site 25
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 103
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 104
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 105
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 106
      • Gifu, Japan
        • Boehringer Ingelheim Investigational Site 56
      • Habikino, Japan
        • Boehringer Ingelheim Investigational Site 80
      • Hakodate, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Hamamatsu, Japan
        • Boehringer Ingelheim Investigational Site 59
      • Handa, Japan
        • Boehringer Ingelheim Investigational Site 64
      • Himeji, Japan
        • Boehringer Ingelheim Investigational Site 82
      • Hirakata, Japan
        • Boehringer Ingelheim Investigational Site 76
      • Hiroshima, Japan
        • Boehringer Ingelheim Investigational Site 86
      • Hiroshima, Japan
        • Boehringer Ingelheim Investigational Site 87
      • Ichinoseki, Japan
        • Boehringer Ingelheim Investigational Site 8
      • Kagoshima, Japan
        • Boehringer Ingelheim Investigational Site 118
      • Kamisu, Japan
        • Boehringer Ingelheim Investigational Site 15
      • Kashiwazaki, Japan
        • Boehringer Ingelheim Investigational Site 50
      • Kasuga, Japan
        • Boehringer Ingelheim Investigational Site 107
      • Kawagoe, Japan
        • Boehringer Ingelheim Investigational Site 24
      • Kawasaki, Japan
        • Boehringer Ingelheim Investigational Site 46
      • Kawatana, Japan
        • Boehringer Ingelheim Investigational Site 111
      • Kawatana, Japan
        • Boehringer Ingelheim Investigational Site 112
      • Kitakyushu, Japan
        • Boehringer Ingelheim Investigational Site 99
      • Kiyotake, Japan
        • Boehringer Ingelheim Investigational Site 117
      • Kobe, Japan
        • Boehringer Ingelheim Investigational Site 83
      • Koga, Japan
        • Boehringer Ingelheim Investigational Site 67
      • Konan, Japan
        • Boehringer Ingelheim Investigational Site 63
      • Koriyama, Japan
        • Boehringer Ingelheim Investigational Site 12
      • Koriyama, Japan
        • Boehringer Ingelheim Investigational Site 13
      • Koshiagya, Japan
        • Boehringer Ingelheim Investigational Site 21
      • Kurume, Japan
        • Boehringer Ingelheim Investigational Site 100
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 68
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 69
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 70
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 71
      • Maebashi, Japan
        • Boehringer Ingelheim Investigational Site 19
      • Maebashi, Japan
        • Boehringer Ingelheim Investigational Site 20
      • Matsumoto, Japan
        • Boehringer Ingelheim Investigational Site 55
      • Mihara, Japan
        • Boehringer Ingelheim Investigational Site 88
      • Minobu, Japan
        • Boehringer Ingelheim Investigational Site 54
      • Miyakonojo, Japan
        • Boehringer Ingelheim Investigational Site 116
      • Miyazaki, Japan
        • Boehringer Ingelheim Investigational Site 114
      • Miyazaki, Japan
        • Boehringer Ingelheim Investigational Site 115
      • Moriguchi, Japan
        • Boehringer Ingelheim Investigational Site 77
      • Morioka, Japan
        • Boehringer Ingelheim Investigational Site 9
      • Moroyama, Japan
        • Boehringer Ingelheim Investigational Site 23
      • Muroran, Japan
        • Boehringer Ingelheim Investigational Site 4
      • Nagaoka, Japan
        • Boehringer Ingelheim Investigational Site 51
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 61
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 62
      • Nangoku, Japan
        • Boehringer Ingelheim Investigational Site 97
      • Naoetsu, Japan
        • Boehringer Ingelheim Investigational Site 102
      • Narita, Japan
        • Boehringer Ingelheim Investigational Site 28
      • Naruto, Japan
        • Boehringer Ingelheim Investigational Site 93
      • Nikko, Japan
        • Boehringer Ingelheim Investigational Site 17
      • Nishihara, Japan
        • Boehringer Ingelheim Investigational Site 119
      • Nishinomiya, Japan
        • Boehringer Ingelheim Investigational Site 81
      • Okawa, Japan
        • Boehringer Ingelheim Investigational Site 98
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site 72
      • Osakasayama, Japan
        • Boehringer Ingelheim Investigational Site 78
      • Otsu, Japan
        • Boehringer Ingelheim Investigational Site 66
      • Saga, Japan
        • Boehringer Ingelheim Investigational Site 108
      • Sagamihara, Japan
        • Boehringer Ingelheim Investigational Site 45
      • Saitama, Japan
        • Boehringer Ingelheim Investigational Site 22
      • Sakai, Japan
        • Boehringer Ingelheim Investigational Site 79
      • Sanjo, Japan
        • Boehringer Ingelheim Investigational Site 52
      • Sanyoonoda, Japan
        • Boehringer Ingelheim Investigational Site 90
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 5
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 6
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 7
      • Sasebo, Japan
        • Boehringer Ingelheim Investigational Site 110
      • Sendai, Japan
        • Boehringer Ingelheim Investigational Site 10
      • Shimonoseki, Japan
        • Boehringer Ingelheim Investigational Site 91
      • Shimotsuke, Japan
        • Boehringer Ingelheim Investigational Site 18
      • Shingu, Japan
        • Boehringer Ingelheim Investigational Site 85
      • Shizuoka, Japan
        • Boehringer Ingelheim Investigational Site 57
      • Shizuoka, Japan
        • Boehringer Ingelheim Investigational Site 58
      • Suita, Japan
        • Boehringer Ingelheim Investigational Site 73
      • Tagawa, Japan
        • Boehringer Ingelheim Investigational Site 101
      • Takamatsu, Japan
        • Boehringer Ingelheim Investigational Site 96
      • Takatsuki, Japan
        • Boehringer Ingelheim Investigational Site 74
      • Takatsuki, Japan
        • Boehringer Ingelheim Investigational Site 75
      • Togitsu, Japan
        • Boehringer Ingelheim Investigational Site 109
      • Tokushima, Japan
        • Boehringer Ingelheim Investigational Site 92
      • Tokyo Adachi-ku, Japan
        • Boehringer Ingelheim Investigational Site 30
      • Tokyo Arakawa-ku, Japan
        • Boehringer Ingelheim Investigational Site 31
      • Tokyo Bunkyo-ku, Japan
        • Boehringer Ingelheim Investigational Site 40
      • Tokyo Bunkyo-ku, Japan
        • Boehringer Ingelheim Investigational Site 41
      • Tokyo Bunkyo-ku, Japan
        • Boehringer Ingelheim Investigational Site 42
      • Tokyo Chiyoda-ku, Japan
        • Boehringer Ingelheim Investigational Site 38
      • Tokyo Itabashi-ku, Japan
        • Boehringer Ingelheim Investigational Site 32
      • Tokyo Itabashi-ku, Japan
        • Boehringer Ingelheim Investigational Site 33
      • Tokyo Meguro-ku, Japan
        • Boehringer Ingelheim Investigational Site 43
      • Tokyo Nakano-ku, Japan
        • Boehringer Ingelheim Investigational Site 39
      • Tokyo Ota-ku, Japan
        • Boehringer Ingelheim Investigational Site 34
      • Tokyo Ota-ku, Japan
        • Boehringer Ingelheim Investigational Site 35
      • Tokyo Shinjuku-ku, Japan
        • Boehringer Ingelheim Investigational Site 36
      • Tokyo Shinjuku-ku, Japan
        • Boehringer Ingelheim Investigational Site 37
      • Tokyo Toshima-ku, Japan
        • Boehringer Ingelheim Investigational Site 44
      • Tomiai, Japan
        • Boehringer Ingelheim Investigational Site 113
      • Toride, Japan
        • Boehringer Ingelheim Investigational Site 14
      • Tsu, Japan
        • Boehringer Ingelheim Investigational Site 65
      • Tsukuba, Japan
        • Boehringer Ingelheim Investigational Site 16
      • Uchinada, Japan
        • Boehringer Ingelheim Investigational Site 53
      • Urayasu, Japan
        • Boehringer Ingelheim Investigational Site 29
      • Wakayama, Japan
        • Boehringer Ingelheim Investigational Site 84
      • Yamaguchi, Japan
        • Boehringer Ingelheim Investigational Site 89
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 47
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 48
      • Yoshinogawa, Japan
        • Boehringer Ingelheim Investigational Site 94

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parkinson's disease patients in daily clinical settings

Description

Inclusion Criteria:

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

Exclusion Criteria:

Patients should have been treated according to the Japanese insert slip

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Time Frame: during 36 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression of Improvement
Time Frame: after 36 months treatment
Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).
after 36 months treatment
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Time Frame: Baseline and at 36 months (or at the time of discontinuation)
Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.
Baseline and at 36 months (or at the time of discontinuation)
Change From Baseline in Modified Hoehn & Yahr Rating Scale
Time Frame: Baseline and at 36 months (or at the time of discontinuation)
A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).
Baseline and at 36 months (or at the time of discontinuation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

June 6, 2014

Last Update Submitted That Met QC Criteria

May 28, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.549

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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