TerminatedPhase 2

Effectiveness of Ropinirole and Gabapentin for the Treatment of RLS in Patients on Maintenance HD

Stopped: Recruitment suspended due to COVID-19 pandemic and will not resume.

Canada3 participantsStarted 2019-02-19

Plain-language summary

Restless legs syndrome (RLS) is a neurologic disorder characterized by 1) an urge to move the legs, 2) uncomfortable sensations in the legs, 3) symptoms that are often worse the evening or when at rest , and 4) may be temporarily relieved by physical activity. The overall prevalence of RLS in the general population is estimated to be around 10%, however, it is significantly in the end stage kidney disease (ESKD) population is significantly higher (approximately 30%). Studies have shown that RLS has a substantial negative impact on both the physical and the mental health dimensions of quality of life (QOL), such as depression, anxiety, pain, fatigue and sleep disorder. While non-pharmacological treatments should be considered for all patients, pharmacological management of RLS is indicated when the affects patient's sleep or quality of life. Gabapentin and dopamine agonists such as ropinirole are usually the first choices in treating RSL. Although these medications are also used in patients with renal impairment, few studies provide treatment data for the hemodialysis population. Treatment recommendations for this population are largely based on data obtained in the general population. This study aims to evaluate effectiveness of ropinirole and gabapentin for the treatment of restless legs syndrome in patients on maintenance hemodialysis.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: ESKD requiring hemodialysis A symptom severity score of at least 4/10 on the restless legs ESAS-r: Renal question for two consecutive reporting periods (i.e over two months) No RLS medication for two weeks prior to study period. Washout Period: Individuals that are receiving RLS medication but are still reporting a severity score of at least 4/10 on the restless legs ESAS-r: Renal they may be eligible if they discontinue their RLS medication for two weeks prior to baseline. At least 18 years of age Exclusion Criteria: Dialysis vintage less than 3 months Unstable medical conditions that prevents taking the study drugs or conditions that could affect efficacy treatment Pregnancy Previous adverse effects to gabapentin or ropinirole such as allergic reaction or augmentation History of drug/alcohol abuse Cognitive Impairment Unable to understand English

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate the effectiveness of ropinirole and gabapentin on the severity of RLS symptoms in the hemodialysis population.

Timeframe: up to 4 & 6 months after start of intervention.

Trial details

NCT IDNCT03708237

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-06

View on ClinicalTrials.gov More Restless Legs Syndrome trials