Restless Legs SyndromeNCT01170091

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

An observational study of Restless Legs Syndrome, run by Boehringer Ingelheim at 36 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Restless Legs Syndrome
How many people: 651 participants
Where: 36 sitesSouth Korea
Study dates: Dec 2007to Feb 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: General hospitals, primary care clinics

Who may be able to join

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

Who cannot join

Any contraindications according to Basic Product Information (Company Core Data Sheet) or local Labelling; hypersensitivity to pramipexole or to any of the excipients.
Ongoing treatment with Mirapex
Pregnant and breastfeeding women
Concomitant pharmacologic treatment with other dopaminergic drugs(including L-dopa)
Secondary RLS

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

South Korea36 sites

Boehringer Ingelheim Investigational Site 1
Busan
Boehringer Ingelheim Investigational Site 2
Busan
Boehringer Ingelheim Investigational Site 3
Busan
Boehringer Ingelheim Investigational Site 32
Daegu
Boehringer Ingelheim Investigational Site 33
Daegu
Boehringer Ingelheim Investigational Site 34
Daejeon
Boehringer Ingelheim Investigational Site 35
Daejeon
Boehringer Ingelheim Investigational Site 36
Deajeon
Boehringer Ingelheim Investigational Site 25
Gwangju
Boehringer Ingelheim Investigational Site 26
Gwangju
Boehringer Ingelheim Investigational Site 27
Gwangju
Boehringer Ingelheim Investigational Site 28
Gwangju
Boehringer Ingelheim Investigational Site 29
Gwangju
Boehringer Ingelheim Investigational Site 30
Gwangju
Boehringer Ingelheim Investigational Site 31
Gwangju
Boehringer Ingelheim Investigational Site 10
Seoul
Boehringer Ingelheim Investigational Site 11
Seoul
Boehringer Ingelheim Investigational Site 12
Seoul
Boehringer Ingelheim Investigational Site 13
Seoul
Boehringer Ingelheim Investigational Site 14
Seoul
Boehringer Ingelheim Investigational Site 15
Seoul
Boehringer Ingelheim Investigational Site 16
Seoul
Boehringer Ingelheim Investigational Site 17
Seoul
Boehringer Ingelheim Investigational Site 18
Seoul
Boehringer Ingelheim Investigational Site 19
Seoul
Boehringer Ingelheim Investigational Site 20
Seoul
Boehringer Ingelheim Investigational Site 21
Seoul
Boehringer Ingelheim Investigational Site 22
Seoul
Boehringer Ingelheim Investigational Site 23
Seoul
Boehringer Ingelheim Investigational Site 24
Seoul
Boehringer Ingelheim Investigational Site 4
Seoul
Boehringer Ingelheim Investigational Site 5
Seoul
Boehringer Ingelheim Investigational Site 6
Seoul
Boehringer Ingelheim Investigational Site 7
Seoul
Boehringer Ingelheim Investigational Site 8
Seoul
Boehringer Ingelheim Investigational Site 9
Seoul

Other trials in South Korea

About this study

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

Read the detailed description

Study Design:

Conditions: Restless Legs Syndrome
Medical subject headings: Restless Legs Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01170091
Study group	Role	What they receive
Pramipexole		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Reported Adverse Events
If there is a dose titration, another 4 weeks should be followed up
Measured: Up to 4 weeks

Secondary outcomes (3)

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
Measured: 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."
Measured: 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."
Measured: before and after the treatment with Mirapex (at least 4 weeks after the end of titration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Feb 2011

First posted27 Jul 2010 (estimated)
Study startDec 2007
Primary completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 651 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01170091
Sponsor's protocol ID: 248.653
Status last verified: Mar 2014
First submitted: 26 Jul 2010
Last updated: 11 Apr 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)

All Restless Legs Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS
ClinicalTrials.gov ID: NCT01170091
Acronym / sponsor ID: 248.653
Conditions: Restless Legs Syndrome
Study type: Observational
Recruitment status: Completed
Enrolment: 651 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Feb 2011 (actual)
First posted: 27 Jul 2010 (estimated)
Results: Posted 11 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study Design:

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Pramipexole	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: General hospitals, primary care clinics

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

Any contraindications according to Basic Product Information (Company Core Data Sheet) or local Labelling; hypersensitivity to pramipexole or to any of the excipients.
Ongoing treatment with Mirapex
Pregnant and breastfeeding women
Concomitant pharmacologic treatment with other dopaminergic drugs(including L-dopa)
Secondary RLS

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Reported Adverse Events
Time frame: Up to 4 weeks
If there is a dose titration, another 4 weeks should be followed up

3 secondary outcomes

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)
Patient-Global Impressions (PGI-I)
Time frame: 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)

Results and safety

Results posted to the registry on 11 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mirapex	651	627

Primary outcome: Number of Reported Adverse Events

Time frame: Up to 4 weeks. Number. Unit: cases

Measure	Mirapex n = 651
Gastrointestinal disorders	8
Nervous system disorders	1
General disorders and admin site conditions	2
Psychiatric disorders	1

Population analysed: Patients with RLS who took at least one dose of Mirapex - Safety Analysis Set

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks (28 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Restless Legs Syndrome (RLS)	0 of 651 (0%)	0 of 651 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Restless Legs Syndrome

RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

36 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Restless Legs Syndrome, run by Boehringer Ingelheim at 36 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Reported Adverse Events (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01170091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2014.