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:
Boehringer Ingelheim Identifier:
First received: July 23, 2008
Last updated: May 18, 2012
Last verified: May 2012

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
Parkinson's Disease
Restless Legs Syndrome
Drug: Pramipexole immediate release

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:
  • International Restless Legs Rating Scale [ Time Frame: Baseline and final visit (week12) ]
    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

  • Global Clinical Impression - Improvement (CGI-I) Scale [ Time Frame: baseline and final visit (week 12) ]
    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

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
Please refer to this study by its identifier: NCT00721279

  Show 127 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, 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 18, 2012
Health Authority: Austria: Federal Office for Safety in Health Care
United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Sleep Disorders, Intrinsic
Sleep Disorders
Mental Disorders
Psychomotor Disorders
Restless Legs Syndrome
Psychomotor Agitation
Neurologic Manifestations
Neurobehavioral Manifestations
Signs and Symptoms
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses processed this record on April 16, 2014