Restless Legs SyndromePhase 3NCT00225862
A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)
A Phase 3 study testing ropinirole in people with Restless Legs Syndrome, run by GlaxoSmithKline at 37 sites in United States.
Trial summary
A 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with 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
- What is being tested?
- ropinirole
- How many people
- 140 participants
- Where
- 37 sitesUnited States
- Study dates
- Jan 2005to Dec 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with a primary sleep disorder other than RLS.
- Patients with symptoms of secondary RLS (i.e., renal failure, iron deficient anemia, pregnancy) or other movement disorders (i.e., Parkinson's Disease).
- Other inclusion or exclusion criteria to be evaluated by the physician.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
GSK Investigational Site
Alabaster, Alabama, 35007
GSK Investigational Site
Albuquerque, New Mexico, 87106
GSK Investigational Site
Albuquerque, New Mexico, 87108
GSK Investigational Site
Amherst, New York, 14226
GSK Investigational Site
Austin, Texas, 78756
GSK Investigational Site
Baton Rouge, Louisiana, 70808
GSK Investigational Site
Bingham Farms, Michigan, 48025
GSK Investigational Site
Chicago, Illinois, 60611
GSK Investigational Site
Columbia, South Carolina, 29201
GSK Investigational Site
Concinnati, Ohio, 45219
GSK Investigational Site
Edison, New Jersey, 08818
GSK Investigational Site
Elk Grove Village, Illinois, 60007
GSK Investigational Site
Fairfield, Connecticut, 06824
GSK Investigational Site
Flossmoor, Illinois, 60422
GSK Investigational Site
Frederick, Maryland, 21702
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
Lafayette Hill, Pennsylvania, 19444
GSK Investigational Site
Largo, Florida, 33773
GSK Investigational Site
New Hyde Park, New York, 11040
GSK Investigational Site
Newton, Massachusetts, 02459
GSK Investigational Site
Newton Center, Massachusetts, 02459
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
Peoria, Arizona, 85381 - 4828
GSK Investigational Site
Phoenix, Arizona, 85032
GSK Investigational Site
Plano, Texas, 75093
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Redondo Beach, California, 90277
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Santa Monica, California, 90404
GSK Investigational Site
St. Petersburg, Florida, 33701
GSK Investigational Site
Tampa, Florida, 33606
GSK Investigational Site
Topeka, Kansas, 66606
GSK Investigational Site
Walla Walla, Washington, 99362
GSK Investigational Site
Wenatchee, Washington, 98801
About this study
Official title: A 12-week, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Intermittent Dosing of Ropinirole in Patients With Restless Legs Syndrome (RLS)
A 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS in the United States.
- Conditions
- Restless Legs Syndrome
- Being tested
- ropinirole
- Keywords
- RLS, 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.
ropiniroleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase.
Measured: 12 Weeks
Secondary outcomes (1)
Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startJan 2005
- Study completionDec 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 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
- 140 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
- NCT00225862
- Sponsor's protocol ID
- 100310
- Status last verified
- Sep 2016
- First submitted
- 30 Jun 2005
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- 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 15 Sep 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 Intermittent Dosing of Ropinirole in Patients With Restless Legs Syndrome (RLS)
- ClinicalTrials.gov ID
- NCT00225862
- Acronym / sponsor ID
- 100310
- Conditions
- Restless Legs Syndrome
- Keywords
- RLS, Restless Legs Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Study completion
- Dec 2005 (actual)
- First posted
- 26 Sep 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 research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with 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 (0 listed)
Key exclusion criteria (3 listed)
- Patients with a primary sleep disorder other than RLS.
- Patients with symptoms of secondary RLS (i.e., renal failure, iron deficient anemia, pregnancy) or other movement disorders (i.e., Parkinson's Disease).
- Other inclusion or exclusion criteria to be evaluated by the physician.
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
Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase.
Time frame: 12 Weeks
1 secondary outcome
Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication.
Time frame: 12 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 15 Sep 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
37 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, run by GlaxoSmithKline at 37 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 0 inclusion and 3 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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?
Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase. (time frame: 12 Weeks). 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 15 Sep 2016.