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NCT01170091 Clinical Trial

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

Restless Legs Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01170091
Other study ID # 248.653
Secondary ID
Status Completed
Phase N/A
First received July 26, 2010
Last updated March 14, 2014
Start date December 2007

Study information
Verified date March 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Korea, Republic of: Korea Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial Summary

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

Description:

Study Design:

Recruitment information / eligibility
Status Completed
Enrollment 651
Est. completion date
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
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 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 Gwangju
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 Seoul

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Reported Adverse Events If there is a dose titration, another 4 weeks should be followed up Up to 4 weeks No
Secondary 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) No
Secondary 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) No
Secondary 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) No
See also
  Status Clinical Trial Phase
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Completed NCT00530530 - ASP8825 - Study in Patients With Restless Legs Syndrome Phase 2
Completed NCT00721279 - Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome N/A
Completed NCT00375284 - A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS Phase 4
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