A Phase 1/2 interventional study of Prednisone and Placebo in Restless Legs Syndrome, sponsored by Scripps Health. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Scripps Health · Phase 1/2, Interventional, and Treatment
Restless legs syndrome is a common sleep-related movement disorder that affects up to 15% of the population in North America, characterized by an uncomfortable urge to move the legs. This has been associated with poor quality of sleep and overall decreased quality of life. Chronic inflammation has been implicated as a key mediator of the low intracranial iron stores that characterize restless legs syndrome (RLS). Current medications for RLS target concomitant low serum iron levels or the dopaminergic pathway, but none target the inflammatory pathway. A novel therapy that focuses on inflammation would allow for additional research into the role of inflammation and cytokines in the development of RLS, and potentially unlock a new class of medications to treat patients with RLS. A small amount of prior evidence suggest that RLS symptoms improve with steroids, with associated improved quality of life, and with decreasing hepcidin levels as a biomarker of symptom severity. This pilot study, using an RCT design, serves to assess the efficacy of glucocorticoids in the alleviation of RLS symptoms, which would further anchor the association between RLS, inflammation, and one of its potential mediators - hepcidin. By giving a prednisone taper versus placebo, this study primarily aims to assess the effect of glucocorticoids on 1) decreasing RLS symptom severity. This study also aims to measure 2) objectively measured improvement in sleep, 3) changes in baseline and post-treatment hepcidin levels, and 4) prevalence of adverse events including psychosis and weight gain. RLS can be a debilitating disease and several non-traditional medications have been tested but with unequivocal results. Glucocorticoids may be an easily accessible and affordable key to better quality of life for RLS patients, especially those with refractory RLS.
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's planned enrollment of 50 is below the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →Scripps Health is the lead sponsor of 45 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
A prednisone taper will be given to the subjects.
Drug: Prednisone
A placebo taper will be given to match the number of pills being tapered in the prednisone group.
Drug: Placebo
A prednisone taper will be given to the subjects as follows: prednisone 40mg for 3 days, prednisone 30mg for 3 days, prednisone 20mg for 3 days, prednisone 10mg for 3 days, prednisone 5mg for 3 days, then off for a total of 15 days.
A placebo taper will be given to match the same number of pills administered in each stage of the prednisone taper.
International Restless Legs Syndrome Study Group rating scale (IRLS)
Evaluates severity of restless legs syndrome symptoms
Time frame: Taken on Day 0, Day 14, and Day 21
Clinical Global Impression (CGI)
Participant quantifies overall severity of illness before and after intervention
Time frame: Taken on Day 0 and Day 21
Epworth Sleepiness Scale (ESS)
Subjective measure of participant's sleepiness
Time frame: Taken on Day 0 and Day 21
Insomnia Severity Index (ISI)
Quantifies participant's perception of insomnia severity
Time frame: Taken on Day 0 and Day 21
Hepcidin levels
Measures serum hepcidin levels
Time frame: Taken on Day 0 and Day 21
Fitbit Sleep Score
Composite of sleep duration, sleep quality, and restoration as measured on Fitbit device based on heart rate variability
Time frame: Taken on Day 0 through Day 21
Generic Assessment of Side Effects (GASE)
Monitors for study related complications
Time frame: Taken on Day 14, Day 21 and Day 35
No study locations are listed for this record.
Plan to share: No — IPD will not be shared to protect patient privacy and confidentiality.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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