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
Study to evaluate treatment effect of pramipexole on RLS severity as measured by IRLS, CGI-I
and RLS-6 and to evaluate the time needed to reach maintenance dose of Pramipexole (PPX)
Clinical Details
Official title: Sifrol® (Pramipexole) Impact on RLS: A 12-weeks 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 scaleAssessment of RLS severity on a 6-point rating scale
Secondary outcome: Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scaleGlobal assessment of efficacy by investigator on a 5-point scale Number of patients with adverse events Time to reach maintenance dose of pramipexole
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients suffering from primary RLS who are planned to be initiated on treatment with
pramipexole as part of the routine care could be included into the study
- Patients not pre-treated with any dopaminergic agent (de novo patients) or patients
pretreated with dopaminergic medication
- Male or female patients of any age
Exclusion Criteria:
- Treating physicians are asked to consider the regulations described in the Summary of
Product Characteristics (SPC) for the treatment with pramipexole
Locations and Contacts
Additional Information
Starting date: February 2006
Last updated: September 22, 2014
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