An observational study in Restless Legs Syndrome, sponsored by Boehringer Ingelheim. Completed at 159 sites in Japan. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2014-08-29.
Sponsored by Boehringer Ingelheim · Observational
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.
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 571 is above the median of 154 across 71 observational studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
500
Patient with Restless Legs Syndrome
Exclusion criteria:
None
Incidence of Drug-related Adverse Events
Number of patients with drug-related adverse events
Time frame: 12 Months
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.
Time frame: after 12 months or at the end of observation
| Milestone | Patient With Restless Legs Syndrome |
|---|---|
| Started | 571 |
| Completed | 566 |
| Not completed | 5 |
| Withdrew: Case report form (crf) not collected | 5 |
Number of patients with drug-related adverse events
| participants | Patient With Restless Legs Syndrome |
|---|---|
| Incidence of Drug-related Adverse Events | 76 |
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.
| Score on a scale | Patient With Restless Legs Syndrome |
|---|---|
| Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS) | -13.42 ± 10.40 |
Collected over During the 12-month period or within 2 days after the last administration of pramipexole, up to 990 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient With Restless Legs Syndrome | — | 10/510 (2%) | 0/510 (0%) |
| Event | Patient With Restless Legs Syndrome |
|---|---|
| Supraventricular tachycardiaCardiac disorders | 1/510 |
| Abdominal painGastrointestinal disorders | 1/510 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/510 |
| IleusGastrointestinal disorders | 1/510 |
| CholangitisHepatobiliary disorders | 1/510 |
| FallInjury, poisoning and procedural complications | 1/510 |
| Radius fractureInjury, poisoning and procedural complications | 1/510 |
| HyperkalaemiaMetabolism and nutrition disorders | 1/510 |
| Metastases to meningesNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/510 |
| Metastases to central nervous systemNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/510 |
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.
| Age, Continuous(years) | Patient With Restless Legs Syndrome |
|---|---|
| Mean | 61.4 ± 16.8 |
| Sex: Female, Male(Participants) | Patient With Restless Legs Syndrome |
|---|---|
| Female | 298 |
| Male | 212 |
Showing the first 100 of 159 sites.
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim