Non-interventional Observational Study of Pramipexole in Restless Legs Syndrome: Impact on Quality of Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00539461
Recruitment Status : Completed
First Posted : October 4, 2007
Last Update Posted : November 1, 2013
Information provided by:
Boehringer Ingelheim

Brief Summary:

In this German non-interventional observational study 1980 patients diagnosed with Restless Legs Syndrome (RLS) will be investigated by 990 General Practitioners across all federal states in Germany. Both moderate to severe RLS patients, with or without previous RLS treatment, suffering from RLS symptoms like a desire to move the extremities usually associated with some discomfort, motor restlessness and worsening of symptoms at rest with at least temporary relief by activity, worsening of symptoms later in the day or at night, are eligible for this study, if it is planned to initiate therapy with pramipexole or to add pramipexole to a previously given, insufficient therapy. Three visits are planned to be documented in this PMS study, one baseline visit, visit two after the end of pramipexole titration and visit three after 12 weeks of treatment. Evaluations and visits are to be carried out and documented only if part of routine medical practice. The main goal of observational studies is to determine how pramipexole treatment works when applied in actual practice and thus maximise external validity. In actual practice patients who have been excluded in the clinical registration trials of PPX in moderate to severe primary RLS (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will be treated with PPX. Thus in addition during this observational study information on the efficacy and safety of PPX in those patients will be obtained. The objectives of this PMS study are:

  • To evaluate the treatment effect of pramipexole on RLS severity and general improvement as measured by IRLS and CGI-I.
  • To evaluate quality of life of RLS patients as measured by the Restless Legs Syndrome Quality of Life questionnaire (RLS-QoL).
  • To evaluate the safety profile of PPX in a natural study population.

Condition or disease
Restless Legs Syndrome

Study Type : Observational
Actual Enrollment : 2023 participants
Time Perspective: Prospective
Official Title: Sifrol® (Pramipexole) Impact on RLS Related Quality of Life: A 12-weeks Observational Study in Patients With Primary RLS
Study Start Date : February 2007
Actual Primary Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Primary Outcome Measures :
  1. Change from baseline in IRLS total score after 12 weeks [ Time Frame: 12 weeks ]
  2. CGI-I responder rate after 12 weeks [ Time Frame: 12 weeks ]
  3. Time to reach maintenance dose [ Time Frame: 12 weeks ]
  4. Change from baseline in RLS-QoL total score after 12 weeks [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in IRLS score after 1-4 weeks [ Time Frame: 4 weeks ]
  2. Change in IRLS items after 12 weeks [ Time Frame: 12 weeks ]
  3. Final dose distribution [ Time Frame: 12 weeks ]
  4. Incidence, relationship and seriousness of adverse events [ Time Frame: 12 weeks ]
  5. Number of premature discontinuations [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
RLS patients

Inclusion Criteria:

  1. Diagnosis of primary RLS
  2. Indication for RLS treatment with Sifrol® (pramipexole)
  3. Male or female patients aged at least 18 years.

Exclusion Criteria:

  1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
  2. Ongoing treatment with Sifrol® (pramipexole).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00539461

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Sponsors and Collaborators
Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT00539461     History of Changes
Other Study ID Numbers: 248.638
First Posted: October 4, 2007    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents