Restless Legs Syndrome (RLS)Phase 3NCT00363857
A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome
A Phase 3 study testing Ropinirole in people with Restless Legs Syndrome (RLS) and Restless Legs Syndrome, run by GlaxoSmithKline at 49 sites in United States.
Trial summary
A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Restless Legs Syndrome (RLS), Restless Legs Syndrome
- What is being tested?
- Ropinirole
- How many people
- 360 participants
- Where
- 49 sitesUnited States
- Study dates
- Aug 2003to May 2004
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Restless Legs Syndrome (RLS) with symptoms such as: uncomfortable or "creepy-crawly" sensations in your legs, overwhelming urge to move your legs to relieve these sensations, sensations go away when you move your legs, or trouble falling asleep or staying asleep because of these symptoms.
- Patients must give written informed consent prior to any specific study procedures.
Who cannot join
- Patients who suffer from narcolepsy, sleep terror disorder, sleepwalking disorder, or a breathing related sleep disorder.
- Patients diagnosed with renal failure (end-stage renal disease) iron deficient anemia or pregnancy.
- Patients suffering from other movement disorders (i.e. Parkinson's Disease).
- Patients who have medical conditions such as diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome.
- Participation in any clinical drug or device trial in the last three months.
- Other inclusion or exclusion criteria to be evaluated by the physician.
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 sites
GSK Investigational Site
Alabaster, Alabama, 35007
GSK Investigational Site
Albuquerque, New Mexico, 87108
GSK Investigational Site
Alexandria, Virginia, 22311
GSK Investigational Site
Atlanta, Georgia, 30329
GSK Investigational Site
Augusta, Georgia, 30912
GSK Investigational Site
Aurora, Colorado, 80012
GSK Investigational Site
Austin, Texas, 78756
GSK Investigational Site
Berkeley, California, 94705
GSK Investigational Site
Birmingham, Alabama, 35294
GSK Investigational Site
Boca Raton, Florida, 33486
GSK Investigational Site
Chicago, Illinois, 60611
GSK Investigational Site
Columbia, South Carolina, 29201
GSK Investigational Site
Columbus, Ohio, 43210-1296
GSK Investigational Site
Concinnati, Ohio, 45219
GSK Investigational Site
Dallas, Texas, 75231
GSK Investigational Site
Danbury, Connecticut, 06810
GSK Investigational Site
Dublin, Ohio, 43017
GSK Investigational Site
Elk Grove Village, Illinois, 60007
GSK Investigational Site
Henderson, Nevada, 89052
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
La Jolla, California, 92037
GSK Investigational Site
Lafayette Hill, Pennsylvania, 19444
GSK Investigational Site
Largo, Florida, 33773
GSK Investigational Site
Lebanon, New Hampshire, 03766
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Louisville, Kentucky, 40217
GSK Investigational Site
Macon, Georgia, 31201
GSK Investigational Site
Nashville, Tennessee, 37205
GSK Investigational Site
Norfolk, Virginia, 23507
GSK Investigational Site
Northridge, California, 91325
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Oxnard, California, 93030
GSK Investigational Site
Pembroke Pines, Florida, 33026
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Phoenix, Arizona, 85032
GSK Investigational Site
Phoenix, Arizona, 85050
GSK Investigational Site
Plano, Texas, 75093
GSK Investigational Site
Portland, Oregon, 97201
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Redondo Beach, California, 90277
GSK Investigational Site
Santa Monica, California, 90404
GSK Investigational Site
Schenectady, New York, 12308
GSK Investigational Site
Southfield, Michigan, 48034
GSK Investigational Site
St. Petersburg, Florida, 33701
GSK Investigational Site
Stanford, California, 94305-5548
GSK Investigational Site
Tampa, Florida, 33606
GSK Investigational Site
Tampa, Florida, 33609
GSK Investigational Site
Tuscaloosa, Alabama, 35406
GSK Investigational Site
Walla Walla, Washington, 99362
About this study
Official title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering From Restless Legs Syndrome (RLS)
A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.
- Being tested
- Ropinirole
- Keywords
- fatigue, sleep, sleep disorder, Legs, RLS, Restless Legs Syndrome, Ropinirole
- Medical subject headings
- Restless Legs Syndrome, Fatigue, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopiniroleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in RLS severity rating scale at Week 12
Secondary outcomes (1)
Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2003
- Primary completionMay 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs Syndrome (RLS)Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363857
- Sponsor's protocol ID
- 101468/249
- Status last verified
- Oct 2016
- First submitted
- 11 Aug 2006
- Last updated
- 17 Oct 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering From Restless Legs Syndrome (RLS)
- ClinicalTrials.gov ID
- NCT00363857
- Acronym / sponsor ID
- 101468/249
- Keywords
- fatigue, sleep, sleep disorder, Legs, RLS, Restless Legs Syndrome, Ropinirole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 15 Aug 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.
A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with Restless Legs Syndrome (RLS) with symptoms such as: uncomfortable or "creepy-crawly" sensations in your legs, overwhelming urge to move your legs to relieve these sensations, sensations go away when you move your legs, or trouble falling asleep or staying asleep because of these symptoms.
- Patients must give written informed consent prior to any specific study procedures.
Key exclusion criteria (6 listed)
- Patients who suffer from narcolepsy, sleep terror disorder, sleepwalking disorder, or a breathing related sleep disorder.
- Patients diagnosed with renal failure (end-stage renal disease) iron deficient anemia or pregnancy.
- Patients suffering from other movement disorders (i.e. Parkinson's Disease).
- Patients who have medical conditions such as diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome.
- Participation in any clinical drug or device trial in the last three months.
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 |
|---|---|---|
| Ropinirole | Drug | – |
Primary outcome
Improvement in RLS severity rating scale at Week 12
1 secondary outcome
Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12.
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 17 Oct 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
49 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 Ropinirole in people with Restless Legs Syndrome (RLS) and Restless Legs Syndrome, run by GlaxoSmithKline at 49 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 2 inclusion and 6 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 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 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?
Improvement in RLS severity rating scale at Week 12. 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 17 Oct 2016.