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Completed

NCT Number: NCT02248155

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

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

Completed

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pramipexole

Drug

Other names: Sifrol®

Primary outcomes

  1. Assessment of RLS symptoms (IRLS) on a 4-point rating scale

    Time frame: up to 12 weeks

  2. Change from Baseline in WPAI by means of a patient questionnaire

    Time frame: Baseline, 12 weeks

Secondary outcomes

  1. Number of patients with adverse drug reactions

    Time frame: up to 12 weeks

  2. Global assessment of efficacy by investigator on a 5-point scale

    Time frame: after 12 weeks

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

    Time frame: up to 12 weeks

  4. Time to reach pramipexol maintenance dose

    Time frame: up to 12 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
First posted
Sep 25, 2014
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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