Restless Legs Syndrome (RLS)Phase 4(CR-RLS)NCT00373542
12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome
A Phase 4 study testing ropinirole CR-RLS in people with Restless Legs Syndrome (RLS) and Restless Legs Syndrome, run by GlaxoSmithKline at 45 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep. 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 CR-RLS
- How many people
- 39 participants
- Where
- 45 sitesUnited States
- Study dates
- Oct 2006to Jun 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- provided written informed consent.
- Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS 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.
- Sleep efficiency <85% OR Latency to persistent sleep >20 minutes.
Who cannot join
- Secondary RLS
- Primary sleep disorder
- Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
- Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
- Use of any prohibited medication.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
GSK Investigational Site
Anaheim, California, 92801
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Auburn, Maine, 04210
GSK Investigational Site
Austell, Georgia, 30106
GSK Investigational Site
Baton Rouge, Louisiana, 70808
GSK Investigational Site
Brandon, Florida, 33511
GSK Investigational Site
Brighton, Massachusetts, 02135
GSK Investigational Site
Charlotte, North Carolina, 28204
GSK Investigational Site
Cincinnati, Ohio, 45246
GSK Investigational Site
Cleveland, Ohio, 44195
GSK Investigational Site
Columbia, South Carolina, 29201
GSK Investigational Site
Corvallis, Oregon, 97330
GSK Investigational Site
Crestview Hills, Kentucky, 41017
GSK Investigational Site
Dallas, Texas, 75213
GSK Investigational Site
Danville, Indiana, 46122
GSK Investigational Site
Dublin, Ohio, 43017
GSK Investigational Site
Duncansville, Pennsylvania, 16635
GSK Investigational Site
Elk Grove Village, Illinois, 60007
GSK Investigational Site
Greenville, North Carolina, 27835
GSK Investigational Site
Greenwood, Colorado, 80111
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
Lafayette, Louisiana, 70503
GSK Investigational Site
Lafayette Hill, Pennsylvania, 19444
GSK Investigational Site
Las Vegas, Nevada, 89104
GSK Investigational Site
Lenexa, Kansas, 66214
GSK Investigational Site
Lexington, Kentucky, 40509
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Louisville, Kentucky, 40217
GSK Investigational Site
Macon, Georgia, 31201
GSK Investigational Site
Normal, Illinois, 61761
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Pembroke Pines, Florida, 33026
GSK Investigational Site
Phoenix, Arizona, 85006
GSK Investigational Site
Portland, Oregon, 97219
GSK Investigational Site
Portland, Oregon, 97239
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92108
GSK Investigational Site
St Louis, Missouri, 63143
GSK Investigational Site
St. Petersburg, Florida, 33707
GSK Investigational Site
Toms River, New Jersey, 08755
GSK Investigational Site
Topeka, Kansas, 66606
GSK Investigational Site
Tulsa, Oklahoma, 74104
GSK Investigational Site
Tuscaloosa, Alabama, 35406
GSK Investigational Site
Walla Walla, Washington, 99362
GSK Investigational Site
Wheat Ridge, Colorado, 80033
About this study
Official title: A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients With Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep
The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.
- Being tested
- ropinirole CR-RLS
- Keywords
- Restless Legs Syndrome, ropinirole, polysomnography, RLS, PSG
- 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 CR-RLSDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12.
Measured: 12 Weeks
Secondary outcomes (1)
Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.
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 posted8 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2007
- Study completionJun 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 39 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
- NCT00373542
- Sponsor's protocol ID
- RRL103660
- Acronym
- (CR-RLS)
- Status last verified
- Oct 2016
- First submitted
- 7 Sep 2006
- Last updated
- 28 Oct 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 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients With Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep
- ClinicalTrials.gov ID
- NCT00373542
- Acronym / sponsor ID
- (CR-RLS) / RRL103660
- Keywords
- Restless Legs Syndrome, ropinirole, polysomnography, RLS, PSG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 8 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.
The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.
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 (4 listed)
- provided written informed consent.
- Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS 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.
- Sleep efficiency <85% OR Latency to persistent sleep >20 minutes.
Key exclusion criteria (5 listed)
- Secondary RLS
- Primary sleep disorder
- Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
- Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
- Use of any prohibited medication.
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 CR-RLS | Drug | – |
Primary outcome
Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12.
Time frame: 12 Weeks
1 secondary outcome
Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.
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 28 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
45 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 ropinirole CR-RLS in people with Restless Legs Syndrome (RLS) and Restless Legs Syndrome, run by GlaxoSmithKline at 45 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 4 inclusion and 5 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 28 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 45 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?
Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency 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 28 Oct 2016.