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Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study
Study Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pramipexole |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Reported Adverse Events | If there is a dose titration, another 4 weeks should be followed up | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment | a change in 10-item scale rated by the patient on 5 levels with a minimum ("none") sum score of 0 to maximum ("very severe") sum score of 40 | before and after the treatment with Mirapex (at least 4 weeks after the end of titration) |
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Inclusion criteria:
Exclusion criteria:
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General hospitals, primary care clinics
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site 1 | Busan | South Korea | ||||
| Boehringer Ingelheim Investigational Site 2 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mirapex | Patients with RLS who had initiated with Mirapex |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Patient-Global Impressions (PGI-I) |
PGI comprises of 7 categories including "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse" and "very much worse." |
| before and after the treatment with Mirapex (at least 4 weeks after the end of titration) |
| Clinical Global Impressions-Global Improvement (CGI-I) | CGI-I comprises of 7 categories including "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse" and "very much worse." | before and after the treatment with Mirapex (at least 4 weeks after the end of titration) |
| Busan |
| South Korea |
| Boehringer Ingelheim Investigational Site 3 | Busan | South Korea |
| Boehringer Ingelheim Investigational Site 32 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 33 | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site 34 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 35 | Daejeon | South Korea |
| Boehringer Ingelheim Investigational Site 36 | Deajeon | South Korea |
| Boehringer Ingelheim Investigational Site 25 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 26 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 27 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 28 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 29 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 30 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 31 | Gwangju | South Korea |
| Boehringer Ingelheim Investigational Site 10 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 11 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 12 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 13 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 14 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 15 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 16 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 17 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 18 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 19 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 20 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 21 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 22 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 23 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 24 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 4 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 5 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 6 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 7 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 8 | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site 9 | Seoul | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Restless Legs Syndrome (RLS) | Patients with RLS who had initiated with Mirapex |
| 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/Gender, Customized | Number | Participants |
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| 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 | Number of Reported Adverse Events | If there is a dose titration, another 4 weeks should be followed up | Patients with RLS who took at least one dose of Mirapex - Safety Analysis Set | Posted | Number | cases | Up to 4 weeks |
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| Secondary | International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment | a change in 10-item scale rated by the patient on 5 levels with a minimum ("none") sum score of 0 to maximum ("very severe") sum score of 40 | Patients whose IRLS scores were assessed at the baseline and at 4 weeks after the end of titration. Efficacy data set (Intent to Treat) | Posted | Mean | Standard Deviation | Units on a scale | before and after the treatment with Mirapex (at least 4 weeks after the end of titration) |
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| Secondary | Patient-Global Impressions (PGI-I) | PGI comprises of 7 categories including "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse" and "very much worse." | Patients whose PGI were assessed at the baseline and at 4 weeks after the end of titration. Efficacy Data Set (Intent to Treat) | Posted | Number | patients | before and after the treatment with Mirapex (at least 4 weeks after the end of titration) |
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| Secondary | Clinical Global Impressions-Global Improvement (CGI-I) | CGI-I comprises of 7 categories including "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse" and "very much worse." | Patients whose CGI-I were assessed at the baseline and at 4 weeks after the end of titration. Efficacy Data Set (Intent to Treat) | Posted | Number | patients | before and after the treatment with Mirapex (at least 4 weeks after the end of titration) |
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4 weeks (28 days)
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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 | Patients With Restless Legs Syndrome (RLS) | Patients with RLS who had initiated with Mirapex | 0 | 651 | 0 | 651 |
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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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| Not reported |
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| Title | Measurements |
|---|---|
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| Psychiatric disorders |
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