Non-interventional Observational Study of Pramipexole in Restless Legs Syndrome: Impact on Quality of Life

Completed

• Conditions: Restless Legs Syndrome

• Registration Number: NCT00539461
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

In this German non-interventional observational study 1980 patients diagnosed with Restless Legs Syndrome (RLS) will be investigated by 990 General Practitioners across all federal states in Germany. Both moderate to severe RLS patients, with or without previous RLS treatment, suffering from RLS symptoms like a desire to move the extremities usually associated with some discomfort, motor restlessness and worsening of symptoms at rest with at least temporary relief by activity, worsening of symptoms later in the day or at night, are eligible for this study, if it is planned to initiate therapy with pramipexole or to add pramipexole to a previously given, insufficient therapy. Three visits are planned to be documented in this PMS study, one baseline visit, visit two after the end of pramipexole titration and visit three after 12 weeks of treatment. Evaluations and visits are to be carried out and documented only if part of routine medical practice. The main goal of observational studies is to determine how pramipexole treatment works when applied in actual practice and thus maximise external validity. In actual practice patients who have been excluded in the clinical registration trials of PPX in moderate to severe primary RLS (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will be treated with PPX. Thus in addition during this observational study information on the efficacy and safety of PPX in those patients will be obtained. The objectives of this PMS study are:

* To evaluate the treatment effect of pramipexole on RLS severity and general improvement as measured by IRLS and CGI-I.

* To evaluate quality of life of RLS patients as measured by the Restless Legs Syndrome Quality of Life questionnaire (RLS-QoL).

* To evaluate the safety profile of PPX in a natural study population.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-09-28
• Study First Submitted QC: 2007-10-02
• Study First Posted: 2007-10-04
• Primary Completion: 2007-11
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2023

Inclusion Criteria

1. Diagnosis of primary RLS
2. Indication for RLS treatment with Sifrol® (pramipexole)
3. Male or female patients aged at least 18 years.

Exclusion Criteria

1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
2. Ongoing treatment with Sifrol® (pramipexole).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to reach maintenance dose	12 weeks
Change from baseline in RLS-QoL total score after 12 weeks	12 weeks
CGI-I responder rate after 12 weeks	12 weeks
Change from baseline in IRLS total score after 12 weeks	12 weeks

Secondary Outcome Measures

Name	Time	Method
Final dose distribution	12 weeks
Number of premature discontinuations	12 weeks
Change in IRLS items after 12 weeks	12 weeks
Change from baseline in IRLS score after 1-4 weeks	4 weeks
Incidence, relationship and seriousness of adverse events	12 weeks

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇩🇪 Hellenthal, Germany