Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome

Study Overview
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Brief Summary
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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

Official Title
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Sifrol Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary RLS

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Drug: Sifrol® (pramipexole dihydrochloride)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary Restless Legs Syndrome (i.e. idiopathic RLS) Indication for treatment with pramipexole Male or female patients older than 18 years Exclusion Criteria: Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients Current treatment with pramipexole

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sifrol® (pramipexole dihydrochloride)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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 | 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 | Up to 12 weeks |