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

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: NCT00721279
Recruitment Status : Completed
First Posted : July 24, 2008
Results First Posted : January 8, 2010
Last Update Posted : June 4, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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 or disease Intervention/treatment
Restless Legs Syndrome Drug: Sifrol® (pramipexole dihydrochloride)

Study Type : Observational
Actual Enrollment : 549 participants
Time Perspective: Prospective
Official Title: Sifrol Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary RLS
Study Start Date : September 2007
Actual Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Primary Outcome Measures :
  1. Frequency Analysis for Baseline Pattern of RLS Symptoms [ Time Frame: Baseline ]
    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.

  2. Change in Total Scores of IRLS (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.

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

  3. Change in 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

  4. Frequency of Adverse Events [ Time Frame: Up to 16 weeks ]
    Frequency of patients with any adverse event, causally related adverse events and serious adverse events

  5. Correlation of the Change in IRLS at End of Titration and at Final Visit [ Time Frame: Up to 12 weeks ]
    Correlation of the change in IRLS at end of titration and at final visit

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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
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

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): NCT00721279

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

Responsible Party: Boehringer Ingelheim Identifier: NCT00721279     History of Changes
Other Study ID Numbers: 248.655
First Posted: July 24, 2008    Key Record Dates
Results First Posted: January 8, 2010
Last Update Posted: June 4, 2014
Last Verified: May 2014

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