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

Completed

• Conditions: Restless Legs Syndrome

• Registration Number: NCT00721279
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-24
• Primary Completion: 2008-10
• Results First Submitted: 2009-10-22
• Results First Submitted QC: 2009-12-07
• Results First Posted: 2010-01-08
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-19
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 549

Inclusion Criteria

• Primary Restless Legs Syndrome (i.e. idiopathic RLS)
• Indication for treatment with pramipexole
• Male or female patients older than 18 years

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency Analysis for Baseline Pattern of RLS Symptoms	Baseline	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.
Change in Total Scores of IRLS (International Restless Legs Rating Scale)	Baseline and final visit (week12)	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.
Change in Global Clinical Impression - Improvement (CGI-I) Scale	baseline and final visit (week 12)	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
Frequency of Adverse Events	Up to 16 weeks	Frequency of patients with any adverse event, causally related adverse events and serious adverse events
Correlation of the Change in IRLS at End of Titration and at Final Visit	Up to 12 weeks	Correlation of the change in IRLS at end of titration and at final visit

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇦🇹 Zirl, Austria