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OpenTrials
Completed

NCT Number: NCT02248142

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

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)

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

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

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

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. Assessment of RLS severity on a 6-point rating scale

    Time frame: up to 12 weeks

Secondary outcomes

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

    Time frame: up to 12 weeks

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

    Time frame: after 12 weeks

  3. Number of patients with adverse events

    Time frame: up to 12 weeks

  4. Time to reach maintenance dose of pramipexole

    Time frame: up to 12 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
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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