Non-interventional Observational Study on the Influence of Pramipexole on Sensory Symptoms of Restless Legs Syndrome (RLS)

Study Overview
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Brief Summary
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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: To investigate the influence of Sifrol® (pramipexole) treatment on unpleasant sensory symptoms of Restless Legs Syndrome as measured with the short form of the McGill Pain Questionnaire. To assess if improvement of sensory symptoms correlates with overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) and with secondary symptoms like sleeping problems and daytime tiredness (items 1 & 6 from Restless Legs Syndrome-6). To evaluate if the treatment effect of Sifrol on overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) differs between patients with high pain scores and patients with lower pain scores. To compare General Practitioner and neurologist sites patient populations in terms of demographics, Restless Legs Syndrome severity at Visit 1 and treatment outcomes at Visit 3. To evaluate the development of behavioural changes under pramipexole treatment.

Detailed Description
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Study Design:

Official Title
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Non-interventional Observational Study on the Influence of Pramipexole (PPX) on Sensory Symptoms of Restless Legs Syndrome (RLS)

Conditions
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Restless Legs Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosis of primary moderate to severe Restless Legs Syndrome. Patients who are planned to be treated with Sifrol® (pramipexole) and where the decision of treatment is made independent of the patients' inclusion into this post marketing surveillance study. Male or female patients aged at least 18 years. Written informed consent by the patient for study participation. Exclusion criteria: Any contraindications according to the Summary of Product Characteristics: hypersensitivity to pramipexole or to any of the excipients. Previous or ongoing treatment with Sifrol® (pramipexole). Previous or ongoing treatment with dopamine receptor agonists.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline to Visit 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline to Visit 3 | 
| Behavioural Changes During Treatment | Number of patients with occurence of behavioural changes in terms of impulse control disorders | Baseline to Visit 3 |