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

March 14, 2014 updated by: Boehringer Ingelheim
Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Study Design:

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
651

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Pramipexole

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Reported Adverse Events
Time Frame: Up to 4 weeks
If there is a dose titration, another 4 weeks should be followed up
Up to 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
Time Frame: before and after the treatment with Mirapex (at least 4 weeks after the end of titration)
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)
Time Frame: before and after the treatment with Mirapex (at least 4 weeks after the end of titration)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 248.653

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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