Restless Legs SyndromePhase 3NCT00133198
Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)
A Phase 3 study testing Pramipexole in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 44 sites in United States.
Trial summary
A 12 week clinical trial was conducted in the United States in order to compare pramipexole (Mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in adult subjects. 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
- 345 participants
- Where
- 44 sitesUnited States
- Study dates
- Apr 2004to Feb 2005
- Phase
- Phase 3
- 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
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Lovelace Scientific Resources
Albuquerque, New Mexico, 87108
1500 N. Bearegard St, #300
Alexandria, Virginia, 22311
5671 Peachtree Dunwoody Road
Atlanta, Georgia, 30342
Atlanta Pulmonary Group, LLC
Atlanta, Georgia, 30342
Movement Disorders Clinic
Augusta, Georgia, 30912
Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana, 70808
PAB Clinical Research
Brandon, Florida, 33511
Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815
Attn: Dr. David Mayleben
Cincinnati, Ohio, 45219
Metrohealth Medical Center
Cleveland, Ohio, 44109
Boehringer Ingelheim Investigational Site
Columbia, South Carolina, 29201
Adult CF Center
Denver, Colorado, 80206
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Henry Ford Hospital - Sleep Disorders and Research Center
Detroit, Michigan, 48202
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
932 Morreene Road #264
Durham, North Carolina, 27705
CNI Movement Disorders Center
Englewood, Colorado, 80113
Boehringer Ingelheim Investigational Site
Fountain Valley, California, 92708
170 Thomas Johnson Dr, Suite 100
Frederick, Maryland, 21702
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa Health Care
Iowa City, Iowa, 52242-1053
Sleep Disorders Center
Jackson, Mississippi, 39216
Center For Sleep Medicine
Lafayette Hill, Pennsylvania, 19444
Mid America NeuroScience Institute
Lenexa, Kansas, 66214
Lynchburg Pulmonary Associates, Inc.
Lynchburg, Virginia, 24501
Sleepmed, Inc
Macon, Georgia, 31201
Winthrop Sleep Disorders Center
Mineola, New York, 11501
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Sleep Health Centers
Newton Center, Massachusetts, 02459
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Attn: Controller/Grants & Contracts Accounting
Oklahoma City, Oklahoma, 73190-3046
Broward Research Group
Pembroke Pines, Florida, 33026-1956
Pivotal Research Centers
Peoria, Arizona, 85381
The Arthritis Group
Philadelphia, Pennsylvania, 19152
Sleep Associates
Plano, Texas, 75093
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
HealthQuest Clinical Trials Research
San Diego, California, 92123
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259
Sleep Medicine Center
St Louis, Missouri, 63108
Clinical Research Group of St Petersburg
St. Petersburg, Florida, 33707
Stanford Sleep Clinic
Stanford, California, 94305-5730
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Cleveland Clinic Florida- Department of Neurology
Weston, Florida, 33331
Wilmington Health Associates
Wilmington, North Carolina, 28401
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Trial Comparing Fixed Doses of 0.25 mg, 0.50 mg and 0.75 mg Pramipexole (Mirapex®) Administered Orally to Investigate the Safety and Efficacy in Patients With Idiopathic Restless Legs Syndrome for 12 Weeks
A 12 week clinical trial was conducted in the United States in order to compare pramipexole (Mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in adult subjects.
- 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.
Change from baseline in the total score of RLSRS (Restless Legs Syndrome rating scale for severity) of the IRLSSG (International Restless Legs Syndrome Study Group)
Measured: week 12
CGI-I (CGI-Improvement)
Measured: week 12
Secondary outcomes (19)
RLSRS response (≥50% reduction from baseline in RLSRS)
Measured: at week 4, 6 and 12
CGI-I responder analysis
Measured: at week 4, 6 and 12
Change from baseline in CGI-Severity
Measured: at week 4, 6 and 12
CGI-therapeutic effect
Measured: at week 4, 6 and 12
CGI-Side effects
Measured: at week 4, 6 and 12
Patient Global Impression (PGI)
Measured: at week 1-4, 6 and 12
Visual analogue scales to assess RLS severity before sleep onset, during night and during day, and satisfaction with sleep
Measured: at week 4, 6 and 12
Change from baseline in Epworth sleepiness scale (ESS)
Measured: at week 4, 6 and 12
Change from baseline in RLS-QOL (Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire)
Measured: at week 6 and 12
Change from baseline in Augmentation Severity Rating Scale of IRLSSG
Measured: at week 6 and 12
Change in systolic and diastolic blood pressure (after 5 minutes supine and subsequently after 1 minute standing)
Measured: week 12
Change in pulse rate (palpation after 5 minute supine and subsequent after 1 minute standing)
Measured: week 12
Change in routine laboratory tests
Measured: week 12
Change in Physical examinations including eye examinations with ophthalmoscopic retinal eye examinations and a full skin dermatologic examination
Measured: week 12
Change in Electrocardiogram
Measured: 12 weeks
Incidence of Adverse evens (including withdrawal symptoms and rebound symptoms)
Measured: up to 93 days
Concomitant medication reporting
Measured: 12 weeks
Early withdrawal phenomena
Measured: 12 weeks
Assessment of sudden onset of sleep (SOOS)
Measured: up to 93 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startApr 2004
- Primary completionFeb 2005
- Study completionFeb 2005
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. Pharmaceuticals,Inc./Ridgefield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133198
- Sponsor's protocol ID
- 248.543
- Status last verified
- Nov 2013
- First submitted
- 22 Aug 2005
- Last updated
- 8 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Trial Comparing Fixed Doses of 0.25 mg, 0.50 mg and 0.75 mg Pramipexole (Mirapex®) Administered Orally to Investigate the Safety and Efficacy in Patients With Idiopathic Restless Legs Syndrome for 12 Weeks
- ClinicalTrials.gov ID
- NCT00133198
- Acronym / sponsor ID
- 248.543
- Conditions
- Restless Legs Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005
- First posted
- 23 Aug 2005 (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.
A 12 week clinical trial was conducted in the United States in order to compare pramipexole (Mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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
Change from baseline in the total score of RLSRS (Restless Legs Syndrome rating scale for severity) of the IRLSSG (International Restless Legs Syndrome Study Group)
Time frame: week 12
CGI-I (CGI-Improvement)
Time frame: week 12
19 secondary outcomes
RLSRS response (≥50% reduction from baseline in RLSRS)
Time frame: at week 4, 6 and 12
CGI-I responder analysis
Time frame: at week 4, 6 and 12
Change from baseline in CGI-Severity
Time frame: at week 4, 6 and 12
CGI-therapeutic effect
Time frame: at week 4, 6 and 12
CGI-Side effects
Time frame: at week 4, 6 and 12
Patient Global Impression (PGI)
Time frame: at week 1-4, 6 and 12
Visual analogue scales to assess RLS severity before sleep onset, during night and during day, and satisfaction with sleep
Time frame: at week 4, 6 and 12
Change from baseline in Epworth sleepiness scale (ESS)
Time frame: at week 4, 6 and 12
Change from baseline in RLS-QOL (Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire)
Time frame: at week 6 and 12
Change from baseline in Augmentation Severity Rating Scale of IRLSSG
Time frame: at week 6 and 12
Change in systolic and diastolic blood pressure (after 5 minutes supine and subsequently after 1 minute standing)
Time frame: week 12
Change in pulse rate (palpation after 5 minute supine and subsequent after 1 minute standing)
Time frame: week 12
Change in routine laboratory tests
Time frame: week 12
Change in Physical examinations including eye examinations with ophthalmoscopic retinal eye examinations and a full skin dermatologic examination
Time frame: week 12
Change in Electrocardiogram
Time frame: 12 weeks
Incidence of Adverse evens (including withdrawal symptoms and rebound symptoms)
Time frame: up to 93 days
Concomitant medication reporting
Time frame: 12 weeks
Early withdrawal phenomena
Time frame: 12 weeks
Assessment of sudden onset of sleep (SOOS)
Time frame: up to 93 days
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 8 Nov 2013.
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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 Coordinator study chair
B.I. Pharmaceuticals,Inc./Ridgefield
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pramipexole in people with Restless Legs Syndrome, run by Boehringer Ingelheim at 44 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?
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 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change from baseline in the total score of RLSRS (Restless Legs Syndrome rating scale for severity) of the IRLSSG (International Restless Legs Syndrome Study Group) (time frame: week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2013.