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

Sifrol® (Pramipexole) Impact on RLS: A 12-weeks Observational Study in Patients With Primary RLS

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02248142

Enrollment

1029

Registered

2014-09-25

Start date

2006-02-28

Completion date

Unknown

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Legs Syndrome

Brief 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)

Interventions

DRUGPramipexole

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Assessment of RLS symptoms (IRLS) on a 4-point rating scale	up to 12 weeks
Assessment of RLS severity on a 6-point rating scale	up to 12 weeks

Secondary

Measure	Time frame
Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale	up to 12 weeks
Global assessment of efficacy by investigator on a 5-point scale	after 12 weeks
Number of patients with adverse events	up to 12 weeks
Time to reach maintenance dose of pramipexole	up to 12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026