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

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