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 Overview

• Status: Completed
• Conditions: Restless Legs Syndrome

Detailed Description

Study Design:

• Study Type: Observational
• Enrollment (Actual): 651

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, 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
  • Daegu, Korea, Republic of
    • Boehringer Ingelheim Investigational Site 32
  • Daegu, Korea, Republic of
    • Boehringer Ingelheim Investigational Site 33
  • Daejeon, Korea, Republic of
    • Boehringer Ingelheim Investigational Site 34
  • Daejeon, Korea, Republic of
    • Boehringer Ingelheim Investigational Site 35
  • Deajeon, Korea, Republic of
    • Boehringer Ingelheim Investigational Site 36
  • 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 27
  • Gwangju, Korea, Republic of
    • Boehringer Ingelheim Investigational Site 28
  • Gwangju, 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
  • 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 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 4
  • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

General hospitals, primary care clinics

Description

Inclusion criteria:

1. Moderate to severe Primary Restless Legs Syndrome
2. Male or female patients aged at least 18 years

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pramipexole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Reported Adverse Events	If there is a dose titration, another 4 weeks should be followed up	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment	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	before and after the treatment with Mirapex (at least 4 weeks after the end of titration)
Patient-Global Impressions (PGI-I)	PGI comprises of 7 categories including "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse" and "very much worse."	before and after the treatment with Mirapex (at least 4 weeks after the end of titration)
Clinical Global Impressions-Global Improvement (CGI-I)	CGI-I comprises of 7 categories including "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse" and "very much worse."	before and after the treatment with Mirapex (at least 4 weeks after the end of titration)

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 26, 2010
• First Posted (Estimate): July 27, 2010

Study Record Updates

• Last Update Posted (Estimate): April 11, 2014
• Last Update Submitted That Met QC Criteria: March 14, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Restless Legs Syndrome
• Other Study ID Numbers: 248.653