Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 404 people across two groups for a 26-week double-blind phase — 207 received a placebo (a dummy treatment) and 197 received a medication called ropinirole IR. Participants could not tell which they were receiving. The trial was mainly measuring changes in restless legs syndrome (RLS) symptom severity, using a standard 10-question scale called the IRLS, where scores range from 0 (no symptoms) to 40 (very severe symptoms). A lower score over time means fewer or less severe symptoms. After the double-blind phase, 269 participants moved into a 40-week open-label phase where everyone received ropinirole IR (meaning both participants and researchers knew what was being taken). The reported data shows that, at the 12-week mark, the placebo group's average IRLS score dropped by 12.1 points from where they started, while the ropinirole IR group's average score dropped by 14.2 points. At week 26, the reported drops were 13.4 points for the placebo group and 15.9 points for the ropinirole IR group. The reported data also shows changes across several secondary measures — including sleep quality (measured using a sleep scale called the MOS-12), quality of life related to RLS (using the Johns Hopkins RLS Quality of Life questionnaire), and general wellbeing (using the SF-36 health survey). In each of these measures, both groups showed changes from their starting scores at weeks 12 and 26, with the direction and size of change varying by measure. For example, reported sleep quantity increased by around 0.5 hours in the placebo group and 0.7 hours in the ropinirole IR group at both timepoints. Quality of life scores, where higher means better, rose in both groups across the measured timepoints. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 23938061) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 4 Restless Legs Syndrome Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Adults aged 18 to 79 years old, both men and women
- Women who either cannot get pregnant (including those who have gone through menopause), or who have a negative pregnancy test and agree to use an acceptable form of birth control during the study
- People who have been formally diagnosed with restless legs syndrome (RLS) using recognised diagnostic methods
- People who have had at least 15 RLS episodes in the past month, or (if previously on RLS medication) who experienced RLS symptoms on at least 4–5 nights during the last week of a medication-free period
- People whose RLS symptoms were present on at least 4 out of the last 7 nights before the study start date
- People whose RLS symptoms score at least 24 points on a standard RLS severity rating scale at the study start
- People whose RLS causes severe or very severe sleep disturbance, or severe or very severe discomfort in the limbs, as measured by a standard rating scale at the study start
- People who experience RLS symptoms at night-time that need treatment
- People who are willing and able to give written consent to take part in the study
Who may not be able to join:
- People who are currently experiencing a worsening of RLS symptoms caused by RLS medication (known as "augmentation"), or a return of symptoms after stopping RLS medication ("rebound"), at the study start
- People who have a history of augmentation in the past
- People who have previously had a bad reaction or intolerance to ropinirole or any similar medication (dopamine agonists)
- People who need treatment for RLS symptoms during the daytime (between 10:00am and 5:00pm)
- People whose RLS appears to be caused by another medical condition, such as kidney failure, iron deficiency anaemia, or pregnancy
- People with a very low blood iron storage level (ferritin below 10 mcg/L) at the screening visit
- People who have another sleep disorder (besides RLS) that could significantly affect their symptoms, such as narcolepsy, sleep terrors, sleepwalking, or a breathing-related sleep disorder
- People diagnosed with movement disorders such as Parkinson's disease, dyskinesias, or dystonias
- People with certain significant medical conditions that could affect the study results or raise safety concerns, including (but not limited to) diabetes, nerve damage, rheumatoid arthritis, fibromyalgia, low blood pressure on standing, severe heart disease, liver or kidney failure, lung scarring, or major psychiatric illness
- People with significantly abnormal blood test results, ECG (heart tracing), or physical exam findings that have not resolved by the study start date, including signs of heart problems on the ECG
- People with blood pressure readings that are too high or too low at the screening or study start visit (confirm with trial site for exact numbers)
- People with a history of alcohol or drug misuse within the past year
- People who are still taking certain medications that cause drowsiness, affect RLS, or affect sleep — and who have not stopped these medications before the study start; these include antipsychotics, anti-seizure drugs, opioid painkillers, anxiety medications, sleeping tablets, lithium, stimulants, dopamine-related drugs, levodopa, clonidine, and sedating antihistamines, among others
- People who have recently started, stopped, or changed the dose of hormone replacement therapy (HRT) or certain other medications that affect a specific liver enzyme (CYP1A2) within 7 days before joining the study (those already on stable doses may be eligible — confirm with trial site)
- People who work night shifts or have sleep schedules that are incompatible with the study, or who would need to significantly change their bedtime during the study
- People who have taken part in another clinical drug or device trial within one month before the study start date
- People who, in the opinion of the study doctor, are unlikely to follow the study schedule or procedures
- Women who have a positive pregnancy test or who are currently breastfeeding
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: GSK Clinical Trials, GlaxoSmithKline
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26; Number of Participants With Clinically Meaningful Augmentation and Early Morning Rebound (EMR) Cases
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.