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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
  Purpose

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


Condition
Restless Legs Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

Resource links provided by NLM:

MedlinePlus related topics: Restless Legs
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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."


Enrollment: 651
Study Start Date: December 2007
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pramipexole

Detailed Description:

Study Design:

  Eligibility

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

General hospitals, primary care clinics

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170091

Locations
Korea, Republic of
Boehringer Ingelheim Investigational Site 1
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 2
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 3
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 32
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 33
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 34
Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 35
Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 36
Deajeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 29
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 30
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 31
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 28
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 27
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 25
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 26
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 16
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 17
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 18
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 19
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 20
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 21
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 22
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 23
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 24
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 5
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 6
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 7
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 8
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 9
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 10
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 11
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 12
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 13
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 14
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 15
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 4
Seoul, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01170091     History of Changes
Other Study ID Numbers: 248.653
Study First Received: July 26, 2010
Results First Received: June 27, 2012
Last Updated: August 9, 2012
Health Authority: Korea, Republic of: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Restless Legs Syndrome
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Pramipexol
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 17, 2012