Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)

Restless Legs Syndrome Clinical Trial

Official title:

Sifrol® Onset of Action and Impact on RLS: A 12-week Observational Study in Patients With Primary RLS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248155
• Other study ID #: 248.618
• Status: Completed
• Phase: N/A
• First received: September 22, 2014
• Last updated: September 22, 2014
• Start date: April 2006

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2644
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome

Intervention

Drug:
• Pramipexole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of RLS symptoms (IRLS) on a 4-point rating scale		up to 12 weeks	No
Primary	Change from Baseline in WPAI by means of a patient questionnaire		Baseline, 12 weeks	No
Secondary	Number of patients with adverse drug reactions		up to 12 weeks	No
Secondary	Global assessment of efficacy by investigator on a 5-point scale		after 12 weeks	No
Secondary	Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale		up to 12 weeks	No
Secondary	Time to reach pramipexol maintenance dose		up to 12 weeks	No

External Links

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