Restless Legs Syndrome Clinical Trial
Official title:
Sifrol Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary RLS
NCT number | NCT00721279 |
Other study ID # | 248.655 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | July 23, 2008 |
Last updated | May 19, 2014 |
Start date | September 2007 |
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
Status | Completed |
Enrollment | 549 |
Est. completion date | |
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 |
Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Austria,
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 |
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