Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome

August 28, 2014 updated by: Boehringer Ingelheim
The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in routine medical practice.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

571

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
      • Akashi, Japan
        • Boehringer Ingelheim Investigational Site 119
      • Akishima, Japan
        • Boehringer Ingelheim Investigational Site 52
      • Akita, Japan
        • Boehringer Ingelheim Investigational Site 16
      • Ami-machi, Japan
        • Boehringer Ingelheim Investigational Site 22
      • Asahi, Japan
        • Boehringer Ingelheim Investigational Site 36
      • Asahikawa, Japan
        • Boehringer Ingelheim Investigational Site 1
      • Chiba, Japan
        • Boehringer Ingelheim Investigational Site 40
      • Chofu, Japan
        • Boehringer Ingelheim Investigational Site 158
      • Chuo, Japan
        • Boehringer Ingelheim Investigational Site 78
      • Fujisawa, Japan
        • Boehringer Ingelheim Investigational Site 66
      • Fukagawa, Japan
        • Boehringer Ingelheim Investigational Site 7
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 144
      • Fukuoka, Japan
        • Boehringer Ingelheim Investigational Site 146
      • Fukushima, Japan
        • Boehringer Ingelheim Investigational Site 19
      • Fukuyama, Japan
        • Boehringer Ingelheim Investigational Site 132
      • Gifu, Japan
        • Boehringer Ingelheim Investigational Site 82
      • Hamamatsu, Japan
        • Boehringer Ingelheim Investigational Site 83
      • Hatchioji, Japan
        • Boehringer Ingelheim Investigational Site 56
      • Hayashima-machi, Japan
        • Boehringer Ingelheim Investigational Site 129
      • Himeji, Japan
        • Boehringer Ingelheim Investigational Site 123
      • Hirakata, Japan
        • Boehringer Ingelheim Investigational Site 111
      • Hiroshima, Japan
        • Boehringer Ingelheim Investigational Site 133
      • Honjo, Japan
        • Boehringer Ingelheim Investigational Site 30
      • Ichihara, Japan
        • Boehringer Ingelheim Investigational Site 38
      • Ichikawa, Japan
        • Boehringer Ingelheim Investigational Site 37
      • Ichikawasango-machi, Japan
        • Boehringer Ingelheim Investigational Site 79
      • Ikeda, Japan
        • Boehringer Ingelheim Investigational Site 117
      • Isahaya, Japan
        • Boehringer Ingelheim Investigational Site 149
      • Itami, Japan
        • Boehringer Ingelheim Investigational Site 118
      • Iwamizawa, Japan
        • Boehringer Ingelheim Investigational Site 10
      • Izumo, Japan
        • Boehringer Ingelheim Investigational Site 127
      • Kagoshima, Japan
        • Boehringer Ingelheim Investigational Site 154
      • Kagoshima, Japan
        • Boehringer Ingelheim Investigational Site 155
      • Kanazawa, Japan
        • Boehringer Ingelheim Investigational Site 74
      • Kanazawa, Japan
        • Boehringer Ingelheim Investigational Site 76
      • Katou, Japan
        • Boehringer Ingelheim Investigational Site 120
      • Kawai-machi, Japan
        • Boehringer Ingelheim Investigational Site 124
      • Kawasaki, Japan
        • Boehringer Ingelheim Investigational Site 60
      • Kawasaki, Japan
        • Boehringer Ingelheim Investigational Site 63
      • Keroyama-machi, Japan
        • Boehringer Ingelheim Investigational Site 31
      • Kitakyuushu, Japan
        • Boehringer Ingelheim Investigational Site 145
      • Kobe, Japan
        • Boehringer Ingelheim Investigational Site 122
      • Kodaira, Japan
        • Boehringer Ingelheim Investigational Site 46
      • Kodaira, Japan
        • Boehringer Ingelheim Investigational Site 50
      • Koshigaya, Japan
        • Boehringer Ingelheim Investigational Site 32
      • Kumamoto, Japan
        • Boehringer Ingelheim Investigational Site 150
      • Kumamoto, Japan
        • Boehringer Ingelheim Investigational Site 151
      • Kurume, Japan
        • Boehringer Ingelheim Investigational Site 143
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 102
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 103
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 98
      • Kyoto, Japan
        • Boehringer Ingelheim Investigational Site 99
      • Maizuru, Japan
        • Boehringer Ingelheim Investigational Site 100
      • Mat?uyama, Japan
        • Boehringer Ingelheim Investigational Site 142
      • Matsumoto, Japan
        • Boehringer Ingelheim Investigational Site 80
      • Matsumoto, Japan
        • Boehringer Ingelheim Investigational Site 81
      • Mibu-machi, Japan
        • Boehringer Ingelheim Investigational Site 28
      • Miki-machi, Japan
        • Boehringer Ingelheim Investigational Site 138
      • Minoo, Japan
        • Boehringer Ingelheim Investigational Site 115
      • Mitaka, Japan
        • Boehringer Ingelheim Investigational Site 47
      • Miyazaki, Japan
        • Boehringer Ingelheim Investigational Site 153
      • Miyoshi, Japan
        • Boehringer Ingelheim Investigational Site 134
      • Moriguchi, Japan
        • Boehringer Ingelheim Investigational Site 112
      • Morioka, Japan
        • Boehringer Ingelheim Investigational Site 13
      • Muroran, Japan
        • Boehringer Ingelheim Investigational Site 2
      • Nagakute-machi, Japan
        • Boehringer Ingelheim Investigational Site 88
      • Nagaokakyo, Japan
        • Boehringer Ingelheim Investigational Site 101
      • Nagareyama, Japan
        • Boehringer Ingelheim Investigational Site 41
      • Nagasaki, Japan
        • Boehringer Ingelheim Investigational Site 148
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 85
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 86
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 87
      • Nagoya, Japan
        • Boehringer Ingelheim Investigational Site 92
      • Nigata, Japan
        • Boehringer Ingelheim Investigational Site 68
      • Nigata, Japan
        • Boehringer Ingelheim Investigational Site 69
      • Nigata, Japan
        • Boehringer Ingelheim Investigational Site 70
      • Nigata, Japan
        • Boehringer Ingelheim Investigational Site 71
      • Niihama, Japan
        • Boehringer Ingelheim Investigational Site 139
      • Niihama, Japan
        • Boehringer Ingelheim Investigational Site 141
      • Ninohe, Japan
        • Boehringer Ingelheim Investigational Site 11
      • Nishinomiya, Japan
        • Boehringer Ingelheim Investigational Site 121
      • Nishitokyo, Japan
        • Boehringer Ingelheim Investigational Site 157
      • Odate, Japan
        • Boehringer Ingelheim Investigational Site 17
      • Oita, Japan
        • Boehringer Ingelheim Investigational Site 152
      • Okayama, Japan
        • Boehringer Ingelheim Investigational Site 130
      • Okayama, Japan
        • Boehringer Ingelheim Investigational Site 131
      • Okazaki, Japan
        • Boehringer Ingelheim Investigational Site 89
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site 104
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site 105
      • Osaka, Japan
        • Boehringer Ingelheim Investigational Site 106
      • Osakasayama, Japan
        • Boehringer Ingelheim Investigational Site 113
      • Ota, Japan
        • Boehringer Ingelheim Investigational Site 128
      • Otsu, Japan
        • Boehringer Ingelheim Investigational Site 97
      • Ozu, Japan
        • Boehringer Ingelheim Investigational Site 140
      • Ryugasaki, Japan
        • Boehringer Ingelheim Investigational Site 26
      • Saga, Japan
        • Boehringer Ingelheim Investigational Site 147
      • Sagamihara, Japan
        • Boehringer Ingelheim Investigational Site 64
      • Saitama, Japan
        • Boehringer Ingelheim Investigational Site 34
      • Sakai, Japan
        • Boehringer Ingelheim Investigational Site 107
      • Sakai, Japan
        • Boehringer Ingelheim Investigational Site 108
      • Sakura, Japan
        • Boehringer Ingelheim Investigational Site 39
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 3
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 4
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 5
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 6
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 8
      • Sapporo, Japan
        • Boehringer Ingelheim Investigational Site 9
      • Sendai, Japan
        • Boehringer Ingelheim Investigational Site 14
      • Sendai, Japan
        • Boehringer Ingelheim Investigational Site 15
      • Shimotsuke, Japan
        • Boehringer Ingelheim Investigational Site 27
      • Shimotsuke, Japan
        • Boehringer Ingelheim Investigational Site 29
      • Shingu, Japan
        • Boehringer Ingelheim Investigational Site 125
      • Shizuoka, Japan
        • Boehringer Ingelheim Investigational Site 84
      • Suzuka, Japan
        • Boehringer Ingelheim Investigational Site 95
      • Suzuka, Japan
        • Boehringer Ingelheim Investigational Site 96
      • Takamatsu, Japan
        • Boehringer Ingelheim Investigational Site 137
      • Takatsuki, Japan
        • Boehringer Ingelheim Investigational Site 109
      • Takatsuki, Japan
        • Boehringer Ingelheim Investigational Site 110
      • Takizawa-mura, Japan
        • Boehringer Ingelheim Investigational Site 12
      • Tokorozawa, Japan
        • Boehringer Ingelheim Investigational Site 33
      • Tokyo Arakawa, Japan
        • Boehringer Ingelheim Investigational Site 42
      • Tokyo Chuo, Japan
        • Boehringer Ingelheim Investigational Site 53
      • Tokyo Itabashi, Japan
        • Boehringer Ingelheim Investigational Site 43
      • Tokyo Meguro, Japan
        • Boehringer Ingelheim Investigational Site 45
      • Tokyo Minato, Japan
        • Boehringer Ingelheim Investigational Site 54
      • Tokyo Nerima, Japan
        • Boehringer Ingelheim Investigational Site 49
      • Tokyo Nerima, Japan
        • Boehringer Ingelheim Investigational Site 55
      • Tokyo Ota, Japan
        • Boehringer Ingelheim Investigational Site 44
      • Tokyo Shibuya, Japan
        • Boehringer Ingelheim Investigational Site 51
      • Tokyo Shibuya, Japan
        • Boehringer Ingelheim Investigational Site 58
      • Tokyo Shinagawa, Japan
        • Boehringer Ingelheim Investigational Site 57
      • Tokyo Shinjyuku, Japan
        • Boehringer Ingelheim Investigational Site 48
      • Toride, Japan
        • Boehringer Ingelheim Investigational Site 21
      • Tottori, Japan
        • Boehringer Ingelheim Investigational Site 126
      • Toyama, Japan
        • Boehringer Ingelheim Investigational Site 72
      • Toyama, Japan
        • Boehringer Ingelheim Investigational Site 73
      • Toyohashi, Japan
        • Boehringer Ingelheim Investigational Site 90
      • Toyohashi, Japan
        • Boehringer Ingelheim Investigational Site 93
      • Toyokawa, Japan
        • Boehringer Ingelheim Investigational Site 91
      • Toyokawa, Japan
        • Boehringer Ingelheim Investigational Site 94
      • Toyonaka, Japan
        • Boehringer Ingelheim Investigational Site 114
      • Toyonaka, Japan
        • Boehringer Ingelheim Investigational Site 116
      • Tsuchiura, Japan
        • Boehringer Ingelheim Investigational Site 20
      • Tsukuba, Japan
        • Boehringer Ingelheim Investigational Site 24
      • Tsuruga, Japan
        • Boehringer Ingelheim Investigational Site 77
      • Tsurugashima, Japan
        • Boehringer Ingelheim Investigational Site 35
      • Urazoe, Japan
        • Boehringer Ingelheim Investigational Site 156
      • Ushiku, Japan
        • Boehringer Ingelheim Investigational Site 23
      • Ushiku, Japan
        • Boehringer Ingelheim Investigational Site 25
      • Utinada-machi, Japan
        • Boehringer Ingelheim Investigational Site 75
      • Yamagata, Japan
        • Boehringer Ingelheim Investigational Site 18
      • Yanai, Japan
        • Boehringer Ingelheim Investigational Site 135
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 59
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 61
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 62
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 65
      • Yokohama, Japan
        • Boehringer Ingelheim Investigational Site 67
      • Yokose-machi, Japan
        • Boehringer Ingelheim Investigational Site 159
      • Yoshinogawa, Japan
        • Boehringer Ingelheim Investigational Site 136

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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

500

Description

Inclusion criteria:

Patient with Restless Legs Syndrome

Exclusion criteria:

None

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

Cohorts and Interventions

Group / Cohort
Patient with Restless Legs Syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Drug-related Adverse Events
Time Frame: 12 Months
Number of patients with drug-related adverse events
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)
Time Frame: after 12 months or at the end of observation
International Restless Legs Syndrome rating scale (IRLS): The IRLS rating scale is a selfrating scale used to evaluate the severity of RLS and the patients are requested to answer 10 questions on a scale of 0 to 4. Respective scores (0-4 points) for the 10 questions were added up to calculate the total score on the IRLS. Therefore the total score is 0-40. The lower values represent a better outcome.
after 12 months or at the end of observation

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

August 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 2, 2010

First Submitted That Met QC Criteria

August 2, 2010

First Posted (Estimate)

August 3, 2010

Study Record Updates

Last Update Posted (Estimate)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.678

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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