An observational study in Restless Legs Syndrome, sponsored by Boehringer Ingelheim. Completed at 785 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-27.
Sponsored by Boehringer Ingelheim · Observational
The main goal of this open-label, prospective, non-controlled, non-interventional post marketing surveillance study is to evaluate how pramipexole treatment works when applied in actual practice. In actual practice patients who would have been excluded in the clinical registration studies of pramipexole in moderate to severe primary Restless Legs Syndrome (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will also be treated with pramipexole. Thus, during this post marketing surveillance study additional information on the efficacy and safety of pramipexole in those patients will be obtained. The objectives of this post marketing surveillance study are:
Study Design:
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 1,504 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.
RLS patients
Exclusion criteria:
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Time frame: Baseline to Visit 3
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by General Practitioner
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Time frame: Baseline to Visit 3
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by Neurologist
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Time frame: Baseline to Visit 3
Summary of Change From Baseline in Restless Legs Syndrome Severity Scale With 6 Questions to Visit 3
Change in RLS-6 at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 20 (worst) A negative change is an improvement of RLS-6, a positive change a worsening of RLS-6.
Time frame: Baseline to Visit 3
Summary of Change From Baseline in International Restless Legs Syndrome Scale for Severity to Visit 3
Change in IRLS at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 40 (worst) A negative change is an improvement of IRLS, a positive change a worsening of IRLS.
Time frame: Baseline to Visit 3
Behavioural Changes During Treatment
Number of patients with occurence of behavioural changes in terms of impulse control disorders
Time frame: Baseline to Visit 3
| Milestone | Pramipexole |
|---|---|
| Started | 1504 |
| Completed | 1409 |
| Not completed | 95 |
| Withdrew: Lack of efficacy | 14 |
| Withdrew: Adverse event | 27 |
| Withdrew: Withdrawal by subject | 26 |
| Withdrew: Lost to follow-up | 8 |
| Withdrew: Other | 20 |
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
| Scores on scale | Pramipexole |
|---|---|
| Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 | -14.48 ± 9.69 |
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
| Scores on scale | Pramipexole |
|---|---|
| Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by General Practitioner | -15.87 ± 9.39 |
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
| Scores on scale | Pramipexole |
|---|---|
| Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by Neurologist | -12.13 ± 9.73 |
Change in RLS-6 at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 20 (worst) A negative change is an improvement of RLS-6, a positive change a worsening of RLS-6.
| Scores on scale | Pramipexole |
|---|---|
| Summary of Change From Baseline in Restless Legs Syndrome Severity Scale With 6 Questions to Visit 3 | -1.63 ± 0.98 |
Change in IRLS at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 40 (worst) A negative change is an improvement of IRLS, a positive change a worsening of IRLS.
| Scores on scale | Pramipexole |
|---|---|
| Summary of Change From Baseline in International Restless Legs Syndrome Scale for Severity to Visit 3 | -17.71 ± 8.86 |
Number of patients with occurence of behavioural changes in terms of impulse control disorders
| participants | Pramipexole |
|---|---|
| Behavioural Changes During Treatment | 8 |
Collected over 14 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pramipexole | — | 6/1,504 (0.4%) | 0/1,504 (0%) |
| Event | Pramipexole |
|---|---|
| DeathGeneral disorders | 2/1504 |
| Muscoloskeletal chest painMusculoskeletal and connective tissue disorders | 1/1504 |
| Hepatic neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/1504 |
| Gallbladder operationSurgical and medical procedures | 1/1504 |
| HospitalizationSurgical and medical procedures | 1/1504 |
| Age, Continuous(Years) | Pramipexole |
|---|---|
| Mean | 65.0 ± 13.0 |
| Gender(participants) | Pramipexole |
|---|---|
| Female | 1008 |
| Male | 490 |
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This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim