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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with Restless Legs Syndrome |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Drug-related Adverse Events | Number of patients with drug-related adverse events | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Patient with Restless Legs Syndrome
Exclusion criteria:
None
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500
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site 119 | Akashi | Japan | ||||
| Boehringer Ingelheim Investigational Site 52 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient With Restless Legs Syndrome | Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| after 12 months or at the end of observation |
| 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 | Chōfu | Japan |
| Boehringer Ingelheim Investigational Site 78 | Chūō | 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 | Honjō | 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 | Katō | 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 101 | Kōtari | 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 80 | Matsumoto | Japan |
| Boehringer Ingelheim Investigational Site 81 | Matsumoto | Japan |
| Boehringer Ingelheim Investigational Site 142 | Matsuyama | 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 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-honmachi | Japan |
| Boehringer Ingelheim Investigational Site 69 | Nigata-honmachi | Japan |
| Boehringer Ingelheim Investigational Site 70 | Nigata-honmachi | Japan |
| Boehringer Ingelheim Investigational Site 71 | Nigata-honmachi | 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 | Nishitōkyō | 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 17 | Ōdate | Japan |
| Boehringer Ingelheim Investigational Site 152 | Ōita | Japan |
| Boehringer Ingelheim Investigational Site 128 | Ōta-ku | Japan |
| Boehringer Ingelheim Investigational Site 97 | Ōtsu | Japan |
| Boehringer Ingelheim Investigational Site 140 | Ōzu | Japan |
| Boehringer Ingelheim Investigational Site 26 | Ryūgasaki | 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 113 | Sayama | 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 | Shingū | 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 | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety set: all patients who were documented to have taken at least one dose of pramipexole except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact.
56 patients who didn't visit hospital after the treatment of pramipexole for RLS were excluded from safety set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient With Restless Legs Syndrome | Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Drug-related Adverse Events | Number of patients with drug-related adverse events | Safety set: all patients who were documented to have taken at least one dose of pramipexole except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact. | Posted | Number | participants | 12 Months |
|
|
| ||||||||||||||||||||||||||
| 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. | Efficacy set: The patient set included all patients in the safety set with approved indication RLS and had IRLS total score measurement at baseline and at least one post-baseline time point. | Posted | Mean | Standard Error | Score on a scale | after 12 months or at the end of observation |
|
|
During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.
Number of participants at risk is based on safety set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient With Restless Legs Syndrome | Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day | 10 | 510 | 0 | 510 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular tachycardia | Cardiac disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MEDDRA 16.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MEDDRA 16.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Impulse-control disorder | Psychiatric disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Somatic hallucination | Psychiatric disorders | MEDDRA 16.1 | Systematic Assessment |
|
Not provided
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
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|