Restless Legs SyndromePhase 4NCT00375284

A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS

A Phase 4 study testing Pramipexole in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 52 sites in United States.

Completed

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

Official record

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Trial summary

This trial is a 6-week, double-blind, randomized, active and placebo-controlled parallel-group study with a primary objective of comparison of starting doses of pramipexole fixed-dose (0.25 mg daily) and pramipexole titrated-dose (0.125 mg qd for 1 week, then 0.25 mg qd for the remaining 5 weeks) with placebo to… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Restless Legs Syndrome
What is being tested?: Pramipexole
How many people: 404 participants
Where: 52 sitesUnited States
Study dates: Sep 2006to Jul 2007
Phase: Phase 4
Are there results?: None posted in the registry

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent consistent with ICH-GCP and local IRB/IEC requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments.
Male or female out-patients 18 to 80 years of age.
Diagnosis of idiopathic RLS according to the clinical RLS criteria revised by the IRLSSG in collaboration with the U.S.A. National Institutes of Health [P03-03355]. All four criteria must be present to fulfil the diagnosis of RLS:
An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs).
The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.

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The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present).
RLS symptoms present at least 2 to 3 days per week during the last 3 months.
IRLS rating scale score >15 at baseline (Visit 2).

Who cannot join

Women of child-bearing potential (i.e., premenopausal women, or postmenopausal women less than 6 months after last menses) who do not use during the clinical trial an adequate method of contraception such as: double barrier protection (e.g., diaphragm or condom and spermicide), intrauterine device, hormonal therapy (oral, injectable, or subcutaneous), or partners surgical sterilization.
Any women of child-bearing potential not having negative pregnancy test at screening.
Breastfeeding women.
Concomitant or previous pharmacologic therapy for RLS as follows:
Any intake of dopamine agonists within 14 days prior to baseline (Visit 2).
Any intake of L-dopa within 14 days prior to baseline (Visit 2).

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Any intake of L-dopa prior to baseline visit, if augmentation in RLS symptoms was observed.
Unsuccessful prior treatment with non-ergot dopamine agonists (e.g., pramipexole, ropinirole).
All treatment less than 14 days before baseline (Visit 2) or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms, e.g., dopaminergic (other than levodopa and dopamine agonists) or antidopaminergic drugs, non-selective MAO inhibitors, sympathomimetics, neuroleptics, antidepressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, ferrous salts, magnesium, folic acid, vitamin B12, antihistaminics, lithium, metoclopramide.
Withdrawal symptoms of any medication must not be present at baseline (Visit 2).
Previous pramipexole non-responders in other indications than RLS.
Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets.
Confirmed diagnosis of diabetes mellitus requiring insulin therapy.
Any of the following lab results at screening:
Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigators discretion.
Haemoglobin (Hb) below lower limit of normal (LLN).

Trial locations and contacts

52 sites in 1 country.

City, postcode or hospital

52 sites in 1 country

United States52 sites

248.616.021 Boehringer Ingelheim Investigational Site
Albany, New York
248.616.036 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
248.616.011 Boehringer Ingelheim Investigational Site
Alexandria, Virginia
248.616.049 Boehringer Ingelheim Investigational Site
Augusta, Georgia
248.616.060 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana
248.616.065 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
248.616.058 Boehringer Ingelheim Investigational Site
Brighton, Massachusetts
248.616.059 Boehringer Ingelheim Investigational Site
Chicago, Illinois
248.616.013 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
248.616.069 Boehringer Ingelheim Investigational Site
Clarks Summit, Pennsylvania
248.616.003 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
248.616.031 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado
248.616.008 Boehringer Ingelheim Investigational Site
Columbia, South Carolina
248.616.033 Boehringer Ingelheim Investigational Site
Columbus, Georgia
248.616.005 Boehringer Ingelheim Investigational Site
Dallas, Texas
248.616.043 Boehringer Ingelheim Investigational Site
DeLand, Florida
248.616.028 Boehringer Ingelheim Investigational Site
Dothan, Alabama
248.616.053 Boehringer Ingelheim Investigational Site
Dover, New Hampshire
248.616.009 Boehringer Ingelheim Investigational Site
Fayetteville, Arkansas
248.616.064 Boehringer Ingelheim Investigational Site
Florissant, Missouri
248.616.040 Boehringer Ingelheim Investigational Site
Foothill Ranch, California
248.616.062 Boehringer Ingelheim Investigational Site
Fullerton, California
248.616.004 Boehringer Ingelheim Investigational Site
Jackson, Mississippi
248.616.014 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
248.616.045 Boehringer Ingelheim Investigational Site
Lenexa, Kansas
248.616.057 Boehringer Ingelheim Investigational Site
Macon, Georgia
248.616.068 Boehringer Ingelheim Investigational Site
Marion, Ohio
248.616.035 Boehringer Ingelheim Investigational Site
Mesa, Arizona
248.616.024 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin
248.616.001 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota
248.616.020 Boehringer Ingelheim Investigational Site
Naples, Florida
248.616.055 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
248.616.012 Boehringer Ingelheim Investigational Site
Norman, Oklahoma
248.616.006 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
248.616.019 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
248.616.061 Boehringer Ingelheim Investigational Site
Olathe, Kansas
248.616.050 Boehringer Ingelheim Investigational Site
Pasadena, California
248.616.048 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
248.616.025 Boehringer Ingelheim Investigational Site
Peoria, Arizona
248.616.073 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
248.616.017 Boehringer Ingelheim Investigational Site
Pueblo, Colorado
248.616.070 Boehringer Ingelheim Investigational Site
Rockwall, Texas
248.616.039 Boehringer Ingelheim Investigational Site
San Marcos, Texas
248.616.066 Boehringer Ingelheim Investigational Site
Savannah, Georgia
248.616.072 Boehringer Ingelheim Investigational Site
Spring Hill, Florida
248.616.016 Boehringer Ingelheim Investigational Site
St Louis, Missouri
248.616.063 Boehringer Ingelheim Investigational Site
St Louis, Missouri
248.616.018 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
248.616.047 Boehringer Ingelheim Investigational Site
Stockbridge, Georgia
248.616.067 Boehringer Ingelheim Investigational Site
Tucson, Arizona
248.616.071 Boehringer Ingelheim Investigational Site
Wallingford, Connecticut
248.616.051 Boehringer Ingelheim Investigational Site
Wellesley Hills, Massachusetts

Other trials in United States

About this study

Official title: A Phase IV Randomised, Double-blind, Active and Placebo-controlled, 6-week Trial to Investigate the Efficacy and Safety of a Starting (and Fixed) Dose 0.25 mg Pramipexole (Mirapex®) in Patients With Idiopathic Restless Legs Syndrome

The secondary objectives of this study will be to assess the onset of action of symptomatic relief of RLS for pramipexole with daily assessment of PGI and modified IRLS during two intervals of the first 2 weeks (Days 2, 3 and 4 and Days 9, 10, and 11) and assessment of IRLS, PGI and CGI-I at Weeks 1, 2, 4 and 6 (CGI-I additionally on Day 3).

Conditions: Restless Legs Syndrome
Being tested: Pramipexole
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.

PramipexoleDrug

What is being measured

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

The co-primary endpoints are: Assessment of clinical response of treatment measured by the change from baseline in total IRLS score and CGI-I responder rate (at least much improved) after 6 weeks, 2 weeks and 1 week.
Measured: 6 weeks

Secondary outcomes (1)

Onset of action on Day 3 as measured by the CGI-I responder rate Onset of action as measured by PGI and modified IRLS score Clinical Global Impression of improvement Patient Global Impression IRLS as a responder rate VAS score for pain in limbs
Measured: 6 weeks

Timeline

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

Sep 2006Jul 2007

First posted12 Sep 2006 (estimated)
Study startSep 2006
Primary completionJul 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Intervention model: Parallel groups
Enrolment: 404 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00375284
Sponsor's protocol ID: 248.616
Status last verified: Oct 2013
First submitted: 11 Sep 2006
Last updated: 31 Oct 2013
Results posted: No

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

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All Restless Legs Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV Randomised, Double-blind, Active and Placebo-controlled, 6-week Trial to Investigate the Efficacy and Safety of a Starting (and Fixed) Dose 0.25 mg Pramipexole (Mirapex®) in Patients With Idiopathic Restless Legs Syndrome
ClinicalTrials.gov ID: NCT00375284
Acronym / sponsor ID: 248.616
Conditions: Restless Legs Syndrome
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 404 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Jul 2007 (actual)
First posted: 12 Sep 2006 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Intervention model: Parallel groups

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Written informed consent consistent with ICH-GCP and local IRB/IEC requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments.
Male or female out-patients 18 to 80 years of age.
Diagnosis of idiopathic RLS according to the clinical RLS criteria revised by the IRLSSG in collaboration with the U.S.A. National Institutes of Health [P03-03355]. All four criteria must be present to fulfil the diagnosis of RLS:
The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
RLS symptoms present at least 2 to 3 days per week during the last 3 months.

Key exclusion criteria (16 listed)

Women of child-bearing potential (i.e., premenopausal women, or postmenopausal women less than 6 months after last menses) who do not use during the clinical trial an adequate method of contraception such as: double barrier protection (e.g., diaphragm or condom and spermicide), intrauterine device, hormonal therapy (oral, injectable, or subcutaneous), or partners surgical sterilization.
Any women of child-bearing potential not having negative pregnancy test at screening.
Breastfeeding women.
Concomitant or previous pharmacologic therapy for RLS as follows:
All treatment less than 14 days before baseline (Visit 2) or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms, e.g., dopaminergic (other than levodopa and dopamine agonists) or antidopaminergic drugs, non-selective MAO inhibitors, sympathomimetics, neuroleptics, antidepressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, ferrous salts, magnesium, folic acid, vitamin B12, antihistaminics, lithium, metoclopramide.

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

Interventions

Intervention	Type	Arms
Pramipexole	Drug	–

Primary outcome

The co-primary endpoints are: Assessment of clinical response of treatment measured by the change from baseline in total IRLS score and CGI-I responder rate (at least much improved) after 6 weeks, 2 weeks and 1 week.
Time frame: 6 weeks

1 secondary outcome

Onset of action on Day 3 as measured by the CGI-I responder rate Onset of action as measured by PGI and modified IRLS score Clinical Global Impression of improvement Patient Global Impression IRLS as a responder rate VAS score for pain in limbs
Time frame: 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

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
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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pramipexole in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 52 sites in United States.

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 9 inclusion and 16 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 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The co-primary endpoints are: Assessment of clinical response of treatment measured by the change from baseline in total IRLS score and CGI-I responder rate (at least much improved) after 6 weeks, 2 weeks and 1 week. (time frame: 6 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 NCT00375284.

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 31 Oct 2013; AzTrials last refreshed its copy on 3 Nov 2026.