Status:

COMPLETED

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

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Restless Legs Syndrome

Eligibility:

All Genders

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)

Eligibility Criteria

Inclusion

  • 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

  • Treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SPC) for the treatment with pramipexole

Key Trial Info

Start Date :

February 1 2006

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

1029 Patients enrolled

Trial Details

Trial ID

NCT02248142

Start Date

February 1 2006

Last Update

September 25 2014

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