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NCT01174459 Clinical Trial

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

Restless Legs Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01174459
Other study ID # 248.678
Secondary ID
Status Completed
Phase N/A
First received August 2, 2010
Last updated August 28, 2014
Start date August 2010
Est. completion date August 2013

Study information
Verified date August 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 571
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 15 Years and older
Eligibility Inclusion criteria:

Patient with Restless Legs Syndrome

Exclusion criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Drug-related Adverse Events Number of patients with drug-related adverse events 12 Months No
Secondary Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS) 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 No
See also
  Status Clinical Trial Phase
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Completed NCT01455012 - Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome Phase 4
Terminated NCT01192503 - Safety and Efficacy of Rasagiline in Restless Legs Syndrome Phase 2/Phase 3
Completed NCT00530530 - ASP8825 - Study in Patients With Restless Legs Syndrome Phase 2
Completed NCT00721279 - Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome N/A
Completed NCT00375284 - A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS Phase 4
Completed NCT00942253 - Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) Phase 2
Completed NCT00479531 - Sequential Compression Devices for Treatment of Restless Legs Syndrome Phase 3
Recruiting NCT05581576 - Pitolisant in Refractory Restless Legs Syndrome Phase 4
Active, not recruiting NCT03218969 - Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist Phase 1/Phase 2
Recruiting NCT04144790 - Impact of Iron Supplementation Treatment on Brain Iron Concentrations
Completed NCT05787080 - Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS) N/A
Not yet recruiting NCT05529095 - Sublingual Apomorphine in Refractory Restless Legs Syndrome Phase 4
Recruiting NCT05044520 - Clinical Features Associated With Restless Legs Syndrome.
Withdrawn NCT03849001 - Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS N/A
Completed NCT03076541 - Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements. N/A
Recruiting NCT04145674 - A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo Phase 2
Completed NCT02532608 - Infra-slow Oscillations During Sleep N/A
Completed NCT01528462 - Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
Completed NCT00748098 - Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance Phase 3

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