An observational study in Restless Legs Syndrome, sponsored by Boehringer Ingelheim. Completed at 127 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-04.
Sponsored by Boehringer Ingelheim · Observational
The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical Impression - Improvement, to evaluate the time to reaching maintenance dose of pramipexole
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Patients with idiopathic RLS
Exclusion Criteria:
Frequency Analysis for Baseline Pattern of RLS Symptoms
Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe.
Time frame: Baseline
Change in Total Scores of IRLS (International Restless Legs Rating Scale)
The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS. The change from baseline was calculated as baseline minus the week 12 value.
Time frame: Baseline and final visit (week12)
Change in Global Clinical Impression - Improvement (CGI-I) Scale
The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse
Time frame: baseline and final visit (week 12)
Frequency of Adverse Events
Frequency of patients with any adverse event, causally related adverse events and serious adverse events
Time frame: Up to 16 weeks
Correlation of the Change in IRLS at End of Titration and at Final Visit
Correlation of the change in IRLS at end of titration and at final visit
Time frame: Up to 12 weeks
| Milestone | De-novo Patients | Pre-treated Patients |
|---|---|---|
| Started | 452 | 97 |
| Completed | 416 | 73 |
| Not completed | 36 | 24 |
| Withdrew: Lack of efficacy | 6 | 3 |
| Withdrew: Tolerability insufficient | 5 | 2 |
| Withdrew: Withdrawal by subject | 13 | 3 |
| Withdrew: Other | 12 | 16 |
Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe.
| percentage of participants | De-novo Patients | Pre-treated Patients |
|---|---|---|
| Mild | 0.7 | 2.4 |
| Moderate | 19.3 | 18.1 |
| Severe | 62.0 | 55.4 |
| Very Severe | 18.0 | 24.1 |
The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS. The change from baseline was calculated as baseline minus the week 12 value.
| scores on a scale | De-novo Patients | Pre-treated Patients |
|---|---|---|
| Change in Total Scores of IRLS (International Restless Legs Rating Scale) | 17 (13.00 to 22.00) | 16 (11.00 to 22.75) |
The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse
| percentage of participants | De-novo Patients | Pre-treated Patients |
|---|---|---|
| Very much improved | 47.0 | 44.6 |
| Much improved | 45.5 | 42.2 |
| Minimally improved | 3.0 | 8.4 |
| No change | 1.8 | 2.4 |
| Minimally worse | 0.0 | 0.0 |
| Much worse | 0.2 | 0.0 |
| Very much worse | 0.0 | 0.0 |
| missing | 2.5 | 2.4 |
Frequency of patients with any adverse event, causally related adverse events and serious adverse events
| participants | Overall |
|---|---|
| Any adverse event | 25 |
| Causally related adverse event | 7 |
| serious adverse events | 2 |
Correlation of the change in IRLS at end of titration and at final visit
| percentage of patients | Overall |
|---|---|
| End of titration - Deterioration (n=517) | 0.0 |
| End of titration - No change (n=517) | 19.7 |
| End of titration - Improvement (n=517) | 80.3 |
| Final Visit - Deterioration | 0.2 |
| Final Visit - No change | 5.4 |
| Final Visit - Improvement | 94.5 |
Collected over Up to 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| De-novo Patients | — | 0/452 (0%) | 0/452 (0%) |
| Pre-treated Patients | — | 2/97 (2.1%) | 0/97 (0%) |
| Event | De-novo Patients | Pre-treated Patients |
|---|---|---|
| EpilepsyNervous system disorders | 0/452 | 1/97 |
| ConfusionPsychiatric disorders | 0/452 | 1/97 |
| Suicidal TendencyPsychiatric disorders | 0/452 | 1/97 |
| DepressionPsychiatric disorders | 0/452 | 1/97 |
SAF - Safety Analysis Set
| Age, Continuous(years) | De-novo Patients | Pre-treated Patients | Total |
|---|---|---|---|
| Mean | 66.48 ± 12.87 | 67.81 ± 12.61 | 66.69 ± 12.82 |
| Sex/Gender, Customized(participants) | De-novo Patients | Pre-treated Patients | Total |
|---|---|---|---|
| Female | 317 | 66 | 383 |
| Male | 131 | 23 | 154 |
| missing | 4 | 8 | 12 |
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This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim