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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 scale

Assessment of RLS severity on a 6-point rating scale

Secondary outcome:

Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale

Global 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

Page last updated: August 23, 2015

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