Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: July 23, 2008
Last updated: May 19, 2014
Last verified: May 2014
The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical Impression - Improvement, to evaluate the time to reaching maintenance dose of pramipexole

Condition Intervention
Restless Legs Syndrome
Drug: Sifrol® (pramipexole dihydrochloride)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Sifrol Onset of Action and Impact: 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:
  • Frequency Analysis for Baseline Pattern of RLS Symptoms [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe.

  • Change in Total Scores of IRLS (International Restless Legs Rating Scale) [ Time Frame: Baseline and final visit (week12) ] [ Designated as safety issue: No ]

    The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS.

    The change from baseline was calculated as baseline minus the week 12 value.

  • Change in Global Clinical Impression - Improvement (CGI-I) Scale [ Time Frame: baseline and final visit (week 12) ] [ Designated as safety issue: No ]
    The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse

  • Frequency of Adverse Events [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    Frequency of patients with any adverse event, causally related adverse events and serious adverse events

  • Correlation of the Change in IRLS at End of Titration and at Final Visit [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Correlation of the change in IRLS at end of titration and at final visit

Enrollment: 549
Study Start Date: September 2007
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • Primary Restless Legs Syndrome (i.e. idiopathic RLS)
  • Indication for treatment with pramipexole
  • Male or female patients older than 18 years

Exclusion Criteria:

  • Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients
  • Current treatment with pramipexole
  Contacts and Locations
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Please refer to this study by its identifier: NCT00721279

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Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim Identifier: NCT00721279     History of Changes
Other Study ID Numbers: 248.655 
Study First Received: July 23, 2008
Results First Received: October 22, 2009
Last Updated: May 19, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychomotor Agitation
Restless Legs Syndrome
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Psychomotor Disorders
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Anti-Dyskinesia Agents
Antiparkinson Agents
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Protective Agents processed this record on May 26, 2016