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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Improvement | 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 |
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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
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Parkinson's disease patients in daily clinical settings
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site 11 | Akita | Japan | ||||
| Boehringer Ingelheim Investigational Site 95 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pramipexole | BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | 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) |
| Anan |
| Japan |
| Boehringer Ingelheim Investigational Site 1 | Asahikawa | Japan |
| Boehringer Ingelheim Investigational Site 2 | Asahikawa | Japan |
| Boehringer Ingelheim Investigational Site 26 | Chiba | Japan |
| Boehringer Ingelheim Investigational Site 27 | Chiba | Japan |
| Boehringer Ingelheim Investigational Site 60 | Fuji | Japan |
| Boehringer Ingelheim Investigational Site 49 | Fujisawa | Japan |
| Boehringer Ingelheim Investigational Site 25 | Fukaya | 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 | Fukuoka | Japan |
| Boehringer Ingelheim Investigational Site 56 | Gifu | Japan |
| Boehringer Ingelheim Investigational Site 80 | Habikino | Japan |
| Boehringer Ingelheim Investigational Site 3 | Hakodate | Japan |
| Boehringer Ingelheim Investigational Site 59 | Hamamatsu | Japan |
| Boehringer Ingelheim Investigational Site 64 | Handa | Japan |
| Boehringer Ingelheim Investigational Site 82 | Himeji | Japan |
| Boehringer Ingelheim Investigational Site 76 | Hirakata | Japan |
| Boehringer Ingelheim Investigational Site 86 | Hiroshima | Japan |
| Boehringer Ingelheim Investigational Site 87 | Hiroshima | Japan |
| Boehringer Ingelheim Investigational Site 8 | Ichinoseki | Japan |
| Boehringer Ingelheim Investigational Site 118 | Kagoshima | Japan |
| Boehringer Ingelheim Investigational Site 15 | Kamisu | Japan |
| Boehringer Ingelheim Investigational Site 50 | Kashiwazaki | Japan |
| Boehringer Ingelheim Investigational Site 107 | Kasuga | Japan |
| Boehringer Ingelheim Investigational Site 24 | Kawagoe | Japan |
| Boehringer Ingelheim Investigational Site 46 | Kawasaki | Japan |
| Boehringer Ingelheim Investigational Site 111 | Kawatana | Japan |
| Boehringer Ingelheim Investigational Site 112 | Kawatana | Japan |
| Boehringer Ingelheim Investigational Site 99 | Kitakyushu | Japan |
| Boehringer Ingelheim Investigational Site 117 | Kiyotake | Japan |
| Boehringer Ingelheim Investigational Site 83 | Kobe | Japan |
| Boehringer Ingelheim Investigational Site 67 | Koga | Japan |
| Boehringer Ingelheim Investigational Site 21 | Koshiagya | Japan |
| Boehringer Ingelheim Investigational Site 63 | Kōnan | Japan |
| Boehringer Ingelheim Investigational Site 12 | Kōriyama | Japan |
| Boehringer Ingelheim Investigational Site 13 | Kōriyama | Japan |
| Boehringer Ingelheim Investigational Site 100 | Kurume | 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 | Kyoto | Japan |
| Boehringer Ingelheim Investigational Site 19 | Maebashi | Japan |
| Boehringer Ingelheim Investigational Site 20 | Maebashi | Japan |
| Boehringer Ingelheim Investigational Site 55 | Matsumoto | Japan |
| Boehringer Ingelheim Investigational Site 88 | Mihara | Japan |
| Boehringer Ingelheim Investigational Site 54 | Minobu | Japan |
| Boehringer Ingelheim Investigational Site 116 | Miyakonojō | Japan |
| Boehringer Ingelheim Investigational Site 114 | Miyazaki | Japan |
| Boehringer Ingelheim Investigational Site 115 | Miyazaki | Japan |
| Boehringer Ingelheim Investigational Site 77 | Moriguchi | Japan |
| Boehringer Ingelheim Investigational Site 9 | Morioka | Japan |
| Boehringer Ingelheim Investigational Site 23 | Morohongō | Japan |
| Boehringer Ingelheim Investigational Site 53 | Mukai-awagasaki | Japan |
| Boehringer Ingelheim Investigational Site 4 | Muroran | Japan |
| Boehringer Ingelheim Investigational Site 51 | Nagaoka | Japan |
| Boehringer Ingelheim Investigational Site 61 | Nagoya | Japan |
| Boehringer Ingelheim Investigational Site 62 | Nagoya | Japan |
| Boehringer Ingelheim Investigational Site 97 | Nangōku | Japan |
| Boehringer Ingelheim Investigational Site 102 | Naoetsu | Japan |
| Boehringer Ingelheim Investigational Site 28 | Narita | Japan |
| Boehringer Ingelheim Investigational Site 93 | Narutō | Japan |
| Boehringer Ingelheim Investigational Site 17 | Nikkō | Japan |
| Boehringer Ingelheim Investigational Site 119 | Nishihara | Japan |
| Boehringer Ingelheim Investigational Site 81 | Nishinomiya | Japan |
| Boehringer Ingelheim Investigational Site 72 | Osaka | Japan |
| Boehringer Ingelheim Investigational Site 98 | Ōkawa | Japan |
| Boehringer Ingelheim Investigational Site 66 | Ōtsu | Japan |
| Boehringer Ingelheim Investigational Site 108 | Saga | Japan |
| Boehringer Ingelheim Investigational Site 45 | Sagamihara | Japan |
| Boehringer Ingelheim Investigational Site 22 | Saitama | Japan |
| Boehringer Ingelheim Investigational Site 79 | Sakai | Japan |
| Boehringer Ingelheim Investigational Site 52 | Sanjō | Japan |
| Boehringer Ingelheim Investigational Site 90 | Sanyōonoda | Japan |
| Boehringer Ingelheim Investigational Site 5 | Sapporo | Japan |
| Boehringer Ingelheim Investigational Site 6 | Sapporo | Japan |
| Boehringer Ingelheim Investigational Site 7 | Sapporo | Japan |
| Boehringer Ingelheim Investigational Site 110 | Sasebo | Japan |
| Boehringer Ingelheim Investigational Site 78 | Sayama | Japan |
| Boehringer Ingelheim Investigational Site 10 | Sendai | Japan |
| Boehringer Ingelheim Investigational Site 91 | Shimonoseki | Japan |
| Boehringer Ingelheim Investigational Site 18 | Shimotsuke | Japan |
| Boehringer Ingelheim Investigational Site 85 | Shingū | Japan |
| Boehringer Ingelheim Investigational Site 57 | Shizuoka | Japan |
| Boehringer Ingelheim Investigational Site 58 | Shizuoka | Japan |
| Boehringer Ingelheim Investigational Site 73 | Suita | Japan |
| Boehringer Ingelheim Investigational Site 101 | Tagawa | Japan |
| Boehringer Ingelheim Investigational Site 96 | Takamatsu | Japan |
| Boehringer Ingelheim Investigational Site 74 | Takatsuki | Japan |
| Boehringer Ingelheim Investigational Site 75 | Takatsuki | Japan |
| Boehringer Ingelheim Investigational Site 109 | Togitsu | Japan |
| Boehringer Ingelheim Investigational Site 92 | Tokushima | Japan |
| Boehringer Ingelheim Investigational Site 30 | Tokyo Adachi-ku | Japan |
| Boehringer Ingelheim Investigational Site 31 | Tokyo Arakawa-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 Bunkyo-ku | Japan |
| Boehringer Ingelheim Investigational Site 38 | Tokyo Chiyoda-ku | Japan |
| Boehringer Ingelheim Investigational Site 32 | Tokyo Itabashi-ku | Japan |
| Boehringer Ingelheim Investigational Site 33 | Tokyo Itabashi-ku | Japan |
| Boehringer Ingelheim Investigational Site 43 | Tokyo Meguro-ku | Japan |
| Boehringer Ingelheim Investigational Site 39 | Tokyo Nakano-ku | Japan |
| Boehringer Ingelheim Investigational Site 34 | Tokyo Ota-ku | Japan |
| Boehringer Ingelheim Investigational Site 35 | Tokyo Ota-ku | Japan |
| Boehringer Ingelheim Investigational Site 36 | Tokyo Shinjuku-ku | Japan |
| Boehringer Ingelheim Investigational Site 37 | Tokyo Shinjuku-ku | Japan |
| Boehringer Ingelheim Investigational Site 44 | Tokyo Toshima-ku | Japan |
| Boehringer Ingelheim Investigational Site 113 | Tomiai | Japan |
| Boehringer Ingelheim Investigational Site 14 | Toride | Japan |
| Boehringer Ingelheim Investigational Site 65 | Tsu | Japan |
| Boehringer Ingelheim Investigational Site 16 | Tsukuba | Japan |
| Boehringer Ingelheim Investigational Site 29 | Urayasu | Japan |
| Boehringer Ingelheim Investigational Site 84 | Wakayama | Japan |
| Boehringer Ingelheim Investigational Site 89 | Yamaguchi | Japan |
| Boehringer Ingelheim Investigational Site 47 | Yokohama | Japan |
| Boehringer Ingelheim Investigational Site 48 | Yokohama | Japan |
| Boehringer Ingelheim Investigational Site 94 | Yoshinogawa | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Data Set for Safety Analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Pramipexole | The number of patients enrolled was 416. The number of case report form which were collected was 364. Moreover the number of patients analyzed as safety analysis was 346 because 18 patients were excluded due to protocol violations. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | 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. | 364 patients had available case report forms. Patients excluded: 5 patients with no visit since the first prescription, 12 irregularly enrolled patients, 9 excluded from analysis according to regulatory requirement, and 1 patient with no safety data available. As a result, there were 346 patients in the safety analysis set. | Posted | Number | Proportion (percentage of participants) | during 36 months |
|
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression of Improvement | Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable). | There were 346 patients in the safety analysis set. Patients excluded from this population: 5 because of administration to patients who didn't suffer from PD and 2 with no efficacy data available. As a result, 339 patients were evaluated for efficacy. | Posted | Number | Participants | after 36 months treatment |
|
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| Secondary | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score | 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. | The number of patients (291) means a population who have the assessment of UPDRS Part III total score at baseline and at least one post-visit after administration of pramipexole. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline and at 36 months (or at the time of discontinuation) |
|
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| Secondary | Change From Baseline in Modified Hoehn & Yahr Rating Scale | 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). | The number of patients (295) means a population who have the assessment of Modified Hoehn & Yahr rating scale at baseline and at least one post-visit after administration of pramipexole. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline and at 36 months (or at the time of discontinuation) |
|
|
36 months
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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 | Pramipexole | The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day). | 29 | 346 | 106 | 346 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| Delusion | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Diabetic hyperosmolar coma | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Neuroleptic malignant syndrome | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Thalamus haemorrhage | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Neurogenic bladder | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Hernia | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Compression fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hallucination | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
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 |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| Title | Measurements |
|---|---|
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