Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Restless Legs Syndrome
Intervention: Pramipexole (Drug)
Phase: N/A
Status: Completed
Sponsored by: Boehringer Ingelheim
Summary
The objectives of this Post Marketing Surveillance (PMS) are:
- Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS)
severity as measured by International Restless Legs Syndrome Scale (IRLS) and Clinical
Global Impression Improvement scale (CGI- I)
- Evaluation of the time to reaching maintenance dose of pramipexole
- Evaluation of work productivity impairment associated with RLS based on the Work
Productivity and Activity Impairment Questionnaire (WPAI) questionnaire
Clinical Details
Official title: Sifrol® Onset of Action and Impact on RLS: A 12-week Observational Study in Patients With Primary RLS
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Assessment of RLS symptoms (IRLS) on a 4-point rating scaleChange from Baseline in WPAI by means of a patient questionnaire
Secondary outcome: Number of patients with adverse drug reactionsGlobal assessment of efficacy by investigator on a 5-point scale Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale Time to reach pramipexol maintenance dose
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients suffering from primary RLS who are eligible for Pramipexol (PPX) treatment
could be included into the study
- Patients not pre-treated with any dopaminergic agent (de novo patients) or patients
pre-treated with dopaminergic medication
- Male of female patients of any age
Exclusion Criteria:
- The treating physicians are asked to consider the regulations described in the
Summary of Product Characteristics (SmPC) for the treatment with pramipexole
Locations and Contacts
Additional Information
Starting date: April 2006
Last updated: September 22, 2014
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