NCT06631300

A Randomized, Placebo-controlled Trial of Prednisone in Refractory Restless Legs Syndrome: a Pilot Study

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Scripps Health · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Prednisone	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.
DRUG	Placebo	A placebo taper will be given to match the same number of pills administered in each stage of the prednisone taper.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-06-01
• Completion: 2025-12-31
• First posted: 2024-10-08
• Last updated: 2024-10-08

Regulatory

• FDA-regulated drug study