Restless Legs SyndromePhase 3NCT00197080
Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome
A Phase 3 study testing Ropinirole Extended Release (XR) in people with Restless Legs Syndrome, run by GlaxoSmithKline at 70 sites in 2 countries.
Trial summary
The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS). 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 Extended Release (XR)
- How many people
- 380 participants
- Where
- 70 sitesin 2 countries
- Study dates
- Jun 2005to Jan 2006
- 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
- Diagnosed with RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS Rating Scale.
- Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.
Who cannot join
- Have secondary RLS.
- Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
Trial locations and contacts
70 sites in 2 countries.
70 sites in 2 countries
United States60 sites
GSK Investigational Site
Alabaster, Alabama, 35007
GSK Investigational Site
Albany, New York, 12205
GSK Investigational Site
Albuquerque, New Mexico, 87108
GSK Investigational Site
Alexandria, Virginia, 22311
GSK Investigational Site
Anaheim, California, 92801
GSK Investigational Site
Atlanta, Georgia, 30338
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Austell, Georgia, 30106
GSK Investigational Site
Baton Rouge, Louisiana, 70808
GSK Investigational Site
Bellingham, Washington, 98226
GSK Investigational Site
Charlottesville, Virginia, 22911
GSK Investigational Site
Cincinnati, Ohio, 45236
GSK Investigational Site
Cleveland, Ohio, 44130
GSK Investigational Site
Colorado Springs, Colorado, 80909
GSK Investigational Site
Columbia, South Carolina, 29201
GSK Investigational Site
Dallas, Texas, 75231
GSK Investigational Site
Dawsonville, Georgia, 30534
GSK Investigational Site
Denver, Colorado, 80212
GSK Investigational Site
Dublin, Ohio, 43017
GSK Investigational Site
Endwell, New York, 13760
GSK Investigational Site
Jackson, Tennessee, 38305
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
Kingston, New York, 12401
GSK Investigational Site
Lafayette Hill, Pennsylvania, 19444
GSK Investigational Site
Largo, Florida, 33773
GSK Investigational Site
Las Vegas, Nevada, 89119
GSK Investigational Site
Lenexa, Kansas, 66214
GSK Investigational Site
Louisville, Kentucky, 40217
GSK Investigational Site
Macon, Georgia, 31201
GSK Investigational Site
Mesa, Arizona, 85201
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
Newton, Massachusetts, 02459
GSK Investigational Site
Northbrook, Illinois, 60062
GSK Investigational Site
Northridge, California, 91325
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Oxnard, California, 93030
GSK Investigational Site
Pasadena, California, 91105
GSK Investigational Site
Pembroke Pines, Florida, 33026
GSK Investigational Site
Peoria, Arizona, 85381 - 4828
GSK Investigational Site
Phoenix, Arizona, 85032
GSK Investigational Site
Portland, Oregon, 97219
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Redondo Beach, California, 90277
GSK Investigational Site
Renton, Washington, 98055
GSK Investigational Site
Salt Lake City, Utah, 84102
GSK Investigational Site
Salt Lake City, Utah, 84121
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92103
GSK Investigational Site
Santa Monica, California, 90404
GSK Investigational Site
Schenectady, New York, 12308
GSK Investigational Site
Spokane, Washington, 99204
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Stuart, Florida, 34996
GSK Investigational Site
Sun City, Arizona, 85351
GSK Investigational Site
Topeka, Kansas, 66606
GSK Investigational Site
Walla Walla, Washington, 99362
GSK Investigational Site
Wenatchee, Washington, 98801
GSK Investigational Site
Westerville, Ohio, 43081
GSK Investigational Site
Wheat Ridge, Colorado, 80033
GSK Investigational Site
Woodstock, Georgia, 30189
Canada10 sites
GSK Investigational Site
Ajax, Ontario, L1S 2J5
GSK Investigational Site
Coquitlam, British Columbia, V3K 3P4
GSK Investigational Site
Edmonton, Alberta, T6G 2C8
GSK Investigational Site
Halifax, Nova Scotia, B3J 3T1
GSK Investigational Site
Langley, British Columbia, V3A 4H9
GSK Investigational Site
Montreal, Quebec, H2T 2N6
GSK Investigational Site
Montreal, Quebec, H4J 1C5
GSK Investigational Site
Regina, Saskatchewan, S4P 0W5
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1
GSK Investigational Site
Trois-Rivières, Quebec, G8Z 4K4
About this study
Official title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients With Restless Legs Syndrome
The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).
- Conditions
- Restless Legs Syndrome
- Being tested
- Ropinirole Extended Release (XR)
- Keywords
- Restless Legs Syndrome, RLS
- 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.
Ropinirole Extended Release (XR)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12.
Measured: 12 Weeks
Secondary outcomes (1)
Assess safety, tolerability, and patient-reported outcomes, including changes in the Clinical Global Impression Scale Scores and changes in the Medical Outcomes Study Sleep Scale at Week 12.
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 posted20 Sep 2005 (estimated)
- Study startJun 2005
- Study completionJan 2006
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
- 380 participants
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
- NCT00197080
- Sponsor's protocol ID
- 101468/205
- Status last verified
- Sep 2016
- First submitted
- 13 Sep 2005
- Last updated
- 23 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 23 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 Ropinirole XR (Extended Release) in Patients With Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT00197080
- Acronym / sponsor ID
- 101468/205
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless Legs Syndrome, RLS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Jan 2006 (actual)
- First posted
- 20 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.
The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).
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)
- Diagnosed with RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS Rating Scale.
- Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.
Key exclusion criteria (2 listed)
- Have secondary RLS.
- Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
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 Extended Release (XR) | Drug | – |
Primary outcome
The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12.
Time frame: 12 Weeks
1 secondary outcome
Assess safety, tolerability, and patient-reported outcomes, including changes in the Clinical Global Impression Scale Scores and changes in the Medical Outcomes Study Sleep Scale at Week 12.
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 23 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
70 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropinirole Extended Release (XR) in people with Restless Legs Syndrome, run by GlaxoSmithKline at 70 sites in 2 countries.
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 2 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 23 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 70 sites in United States, Canada. 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?
The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12. (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 23 Sep 2016.