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

Restless Legs Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721279
• Other study ID #: 248.655
• Status: Completed
• Phase: N/A
• First received: July 23, 2008
• Last updated: May 19, 2014
• Start date: September 2007

Study information

• Verified date: May 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 549
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome

Intervention

Drug:
• Sifrol® (pramipexole dihydrochloride)

Locations

Country	Name	City	State
Austria	Boehringer Ingelheim Investigational Site	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	Bärnbach
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	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	Längenfeld
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	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	Schörfling
Austria	Boehringer Ingelheim Investigational Site	Schwaz
Austria	Boehringer Ingelheim Investigational Site	Schwechat
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	Völs
Austria	Boehringer Ingelheim Investigational Site	Vorchdorf
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	Weißkirchen
Austria	Boehringer Ingelheim Investigational Site	Weiz
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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)	No
Primary	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)	No
Primary	Frequency of Adverse Events	Frequency of patients with any adverse event, causally related adverse events and serious adverse events	Up to 16 weeks	No
Primary	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	No