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Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01170091
First received: July 26, 2010
Last updated: August 9, 2012
Last verified: August 2012
History of Changes

July 26, 2010
August 9, 2012
December 2007
February 2011   (final data collection date for primary outcome measure)
Number of Reported Adverse Events [ Time Frame: Minimum 4 weeks ] [ Designated as safety issue: No ]
If there is a dose titration, another 4 weeks should be followed up
Not Provided
Complete list of historical versions of study NCT01170091 on ClinicalTrials.gov Archive Site
  • International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment [ Time Frame: before and after the treatment with Mirapex (at least 4 weeks after the end of titration) ] [ Designated as safety issue: No ]
    a change in 10-item scale rated by the patient on 5 levels with a minimum ("none") sum score of 0 to maximum ("very severe") sum score of 40
  • Patient-Global Impressions (PGI-I) [ Time Frame: before and after the treatment with Mirapex (at least 4 weeks after the end of titration) ] [ Designated as safety issue: No ]
    PGI comprises of 7 categories including "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse" and "very much worse."
  • Clinical Global Impressions-Global Improvement (CGI-I) [ Time Frame: before and after the treatment with Mirapex (at least 4 weeks after the end of titration) ] [ Designated as safety issue: No ]
    CGI-I comprises of 7 categories including "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse" and "very much worse."
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Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS
Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study

Study Design:
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

General hospitals, primary care clinics
Restless Legs Syndrome
Not Provided
Pramipexole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
651
Not Provided
February 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Moderate to severe Primary Restless Legs Syndrome
  2. Male or female patients aged at least 18 years
  3. Indication for RLS treatment with Mirapex

Exclusion criteria:

  1. Any contraindications according to Basic Product Information (Company Core Data Sheet) or local Labelling; hypersensitivity to pramipexole or to any of the excipients.
  2. Ongoing treatment with Mirapex
  3. Pregnant and breastfeeding women
  4. Concomitant pharmacologic treatment with other dopaminergic drugs(including L-dopa)
  5. Secondary RLS
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01170091
248.653
Not Provided
Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP