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NCT02248142 Clinical Trial

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

Restless Legs Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02248142
Other study ID # 248.623
Secondary ID
Status Completed
Phase N/A
First received September 22, 2014
Last updated September 22, 2014
Start date February 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

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)

Recruitment information / eligibility
Status Completed
Enrollment 1029
Est. completion date
Est. primary completion date January 2007
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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 Assessment of RLS severity on a 6-point rating scale up to 12 weeks No
Secondary Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale up to 12 weeks No
Secondary Global assessment of efficacy by investigator on a 5-point scale after 12 weeks No
Secondary Number of patients with adverse events up to 12 weeks No
Secondary Time to reach maintenance dose of pramipexole up to 12 weeks No
See also
  Status Clinical Trial Phase
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Completed NCT01455012 - Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome Phase 4
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Completed NCT00721279 - Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome N/A
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Completed NCT01528462 - Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
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