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

May 19, 2014 updated by: Boehringer Ingelheim

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

549

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Absam, Austria
        • Boehringer Ingelheim Investigational Site
      • Absdorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Afritz, Austria
        • Boehringer Ingelheim Investigational Site
      • Alkoven, Austria
        • Boehringer Ingelheim Investigational Site
      • Altenmarkt/Zauchensee, Austria
        • Boehringer Ingelheim Investigational Site
      • Anif, Austria
        • Boehringer Ingelheim Investigational Site
      • Au, Austria
        • Boehringer Ingelheim Investigational Site
      • Bad Goisern, Austria
        • Boehringer Ingelheim Investigational Site
      • Bad Schallerbach, Austria
        • Boehringer Ingelheim Investigational Site
      • Bad Vöslau, Austria
        • Boehringer Ingelheim Investigational Site
      • Baden, Austria
        • Boehringer Ingelheim Investigational Site
      • Bleiburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Bludenz, Austria
        • Boehringer Ingelheim Investigational Site
      • Bregenz, Austria
        • Boehringer Ingelheim Investigational Site
      • Bruck a.d. Mur, Austria
        • Boehringer Ingelheim Investigational Site
      • Bärnbach, Austria
        • Boehringer Ingelheim Investigational Site
      • Deutschkreutz, Austria
        • Boehringer Ingelheim Investigational Site
      • Deutschlandsberg, Austria
        • Boehringer Ingelheim Investigational Site
      • Dornbirn, Austria
        • Boehringer Ingelheim Investigational Site
      • Ebensee, Austria
        • Boehringer Ingelheim Investigational Site
      • Faak am See, Austria
        • Boehringer Ingelheim Investigational Site
      • Ferlach, Austria
        • Boehringer Ingelheim Investigational Site
      • Fieberbrunn, Austria
        • Boehringer Ingelheim Investigational Site
      • Filzmoos, Austria
        • Boehringer Ingelheim Investigational Site
      • Fischamend, Austria
        • Boehringer Ingelheim Investigational Site
      • Fonsdorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Fritzens, Austria
        • Boehringer Ingelheim Investigational Site
      • Gallizien, Austria
        • Boehringer Ingelheim Investigational Site
      • Gallspach, Austria
        • Boehringer Ingelheim Investigational Site
      • Gaspoldshofen, Austria
        • Boehringer Ingelheim Investigational Site
      • Gerasdorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Gloggnitz, Austria
        • Boehringer Ingelheim Investigational Site
      • Gmunden, Austria
        • Boehringer Ingelheim Investigational Site
      • Grafenstein, Austria
        • Boehringer Ingelheim Investigational Site
      • Graz, Austria
        • Boehringer Ingelheim Investigational Site
      • Groß Klein, Austria
        • Boehringer Ingelheim Investigational Site
      • Grünbach, Austria
        • Boehringer Ingelheim Investigational Site
      • Haid, Austria
        • Boehringer Ingelheim Investigational Site
      • Halbturn, Austria
        • Boehringer Ingelheim Investigational Site
      • Hall in Tirol, Austria
        • Boehringer Ingelheim Investigational Site
      • Hart, Austria
        • Boehringer Ingelheim Investigational Site
      • Heidenreichstein, Austria
        • Boehringer Ingelheim Investigational Site
      • Hornstein, Austria
        • Boehringer Ingelheim Investigational Site
      • Innsbruck, Austria
        • Boehringer Ingelheim Investigational Site
      • Jenbach, Austria
        • Boehringer Ingelheim Investigational Site
      • Judenburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Kapfenberg, Austria
        • Boehringer Ingelheim Investigational Site
      • Kematen, Austria
        • Boehringer Ingelheim Investigational Site
      • Klagenfurt, Austria
        • Boehringer Ingelheim Investigational Site
      • Kleinzell, Austria
        • Boehringer Ingelheim Investigational Site
      • Klosterneuburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Krems, Austria
        • Boehringer Ingelheim Investigational Site
      • Kufstein, Austria
        • Boehringer Ingelheim Investigational Site
      • Laakirchen, Austria
        • Boehringer Ingelheim Investigational Site
      • Langenwang, Austria
        • Boehringer Ingelheim Investigational Site
      • Lavamünd, Austria
        • Boehringer Ingelheim Investigational Site
      • Leibnitz, Austria
        • Boehringer Ingelheim Investigational Site
      • Leoben, Austria
        • Boehringer Ingelheim Investigational Site
      • Leopoldsdorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Linz, Austria
        • Boehringer Ingelheim Investigational Site
      • Litschau, Austria
        • Boehringer Ingelheim Investigational Site
      • Litzelsdorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Lofer, Austria
        • Boehringer Ingelheim Investigational Site
      • Längenfeld, Austria
        • Boehringer Ingelheim Investigational Site
      • Marbach, Austria
        • Boehringer Ingelheim Investigational Site
      • Mattersburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Meiningen, Austria
        • Boehringer Ingelheim Investigational Site
      • Melk, Austria
        • Boehringer Ingelheim Investigational Site
      • Micheldorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Michelhausen, Austria
        • Boehringer Ingelheim Investigational Site
      • Mödling, Austria
        • Boehringer Ingelheim Investigational Site
      • Münzbach, Austria
        • Boehringer Ingelheim Investigational Site
      • Neufelden, Austria
        • Boehringer Ingelheim Investigational Site
      • Neunkirchen, Austria
        • Boehringer Ingelheim Investigational Site
      • Ottenheim, Austria
        • Boehringer Ingelheim Investigational Site
      • Pabneukirchen, Austria
        • Boehringer Ingelheim Investigational Site
      • Parndorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Passail, Austria
        • Boehringer Ingelheim Investigational Site
      • Pernegg, Austria
        • Boehringer Ingelheim Investigational Site
      • Pinggau, Austria
        • Boehringer Ingelheim Investigational Site
      • Pischelsdorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Poysdorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Reichental, Austria
        • Boehringer Ingelheim Investigational Site
      • Ried im Innkreis, Austria
        • Boehringer Ingelheim Investigational Site
      • Roppen, Austria
        • Boehringer Ingelheim Investigational Site
      • Rüstorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Salzburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Sandl, Austria
        • Boehringer Ingelheim Investigational Site
      • Sankt Florian, Austria
        • Boehringer Ingelheim Investigational Site
      • Sankt Gertraud, Austria
        • Boehringer Ingelheim Investigational Site
      • Sankt Pölten, Austria
        • Boehringer Ingelheim Investigational Site
      • Satteins, Austria
        • Boehringer Ingelheim Investigational Site
      • Schattendorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Schwaz, Austria
        • Boehringer Ingelheim Investigational Site
      • Schwechat, Austria
        • Boehringer Ingelheim Investigational Site
      • Schörfling, Austria
        • Boehringer Ingelheim Investigational Site
      • Soielberg, Austria
        • Boehringer Ingelheim Investigational Site
      • Spielberg, Austria
        • Boehringer Ingelheim Investigational Site
      • St. Andrä, Austria
        • Boehringer Ingelheim Investigational Site
      • St. Peter, Austria
        • Boehringer Ingelheim Investigational Site
      • St. Valentin, Austria
        • Boehringer Ingelheim Investigational Site
      • St. Veit an der Glan, Austria
        • Boehringer Ingelheim Investigational Site
      • Steinbrunn, Austria
        • Boehringer Ingelheim Investigational Site
      • Stockerau, Austria
        • Boehringer Ingelheim Investigational Site
      • Strallegg, Austria
        • Boehringer Ingelheim Investigational Site
      • Telfs, Austria
        • Boehringer Ingelheim Investigational Site
      • Veitsch, Austria
        • Boehringer Ingelheim Investigational Site
      • Villach, Austria
        • Boehringer Ingelheim Investigational Site
      • Vorchdorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Völs, Austria
        • Boehringer Ingelheim Investigational Site
      • Wagna, Austria
        • Boehringer Ingelheim Investigational Site
      • Walding, Austria
        • Boehringer Ingelheim Investigational Site
      • Wals, Austria
        • Boehringer Ingelheim Investigational Site
      • Wartberg, Austria
        • Boehringer Ingelheim Investigational Site
      • Wattens, Austria
        • Boehringer Ingelheim Investigational Site
      • Weer, Austria
        • Boehringer Ingelheim Investigational Site
      • Weiz, Austria
        • Boehringer Ingelheim Investigational Site
      • Weißkirchen, Austria
        • Boehringer Ingelheim Investigational Site
      • Wels, Austria
        • Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • Boehringer Ingelheim Investigational Site
      • Wiener Neudorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Wieselburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Wilhelmsburg, Austria
        • Boehringer Ingelheim Investigational Site
      • Windhaag, Austria
        • Boehringer Ingelheim Investigational Site
      • Wolkersdorf, Austria
        • Boehringer Ingelheim Investigational Site
      • Wr. Neustadt, Austria
        • Boehringer Ingelheim Investigational Site
      • Zirl, Austria
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with idiopathic RLS

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency Analysis for Baseline Pattern of RLS Symptoms
Time Frame: 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.
Baseline
Change in Total Scores of IRLS (International Restless Legs Rating Scale)
Time Frame: 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.
Baseline and final visit (week12)
Change in Global Clinical Impression - Improvement (CGI-I) Scale
Time Frame: 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
baseline and final visit (week 12)
Frequency of Adverse Events
Time Frame: Up to 16 weeks
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
Time Frame: Up to 12 weeks
Correlation of the change in IRLS at end of titration and at final visit
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

July 23, 2008

First Submitted That Met QC Criteria

July 23, 2008

First Posted (Estimate)

July 24, 2008

Study Record Updates

Last Update Posted (Estimate)

June 4, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.655

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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