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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00539461
First received: September 28, 2007
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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
Restless Legs Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Sifrol® (Pramipexole) Impact on RLS Related Quality of Life: A 12-weeks Observational Study in Patients With Primary RLS

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change from baseline in IRLS total score after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • CGI-I responder rate after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Time to reach maintenance dose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in RLS-QoL total score after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in IRLS score after 1-4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in IRLS items after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Final dose distribution [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Incidence, relationship and seriousness of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of premature discontinuations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 2023
Study Start Date: February 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

RLS patients

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539461

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Hellenthal, Germany
Sponsors and Collaborators
Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00539461     History of Changes
Other Study ID Numbers: 248.638
Study First Received: September 28, 2007
Last Updated: October 31, 2013
Health Authority: Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinalprodukte

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on October 01, 2014