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

Launched by SCRIPPS HEALTH · Oct 6, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether a medication called prednisone can help people with a condition known as refractory Restless Legs Syndrome (RLS). RLS is a common disorder that causes an uncomfortable urge to move your legs, often leading to poor sleep and affecting daily life. The study will compare the effects of prednisone, a type of steroid that reduces inflammation, to a placebo (a harmless sugar pill) to see if it can lessen RLS symptoms, improve sleep quality, and lower levels of a specific protein called hepcidin, which may be linked to RLS severity.

To participate in this trial, you must be an adult aged between 18 and 75 who has RLS that hasn't responded to standard treatments. This means you still have bothersome symptoms even after trying other medications. Unfortunately, individuals who are pregnant, have certain health conditions like diabetes or uncontrolled high blood pressure, or have had bad reactions to steroids in the past cannot join. If you take part, you’ll receive either the medication or placebo and be monitored for changes in your symptoms and any side effects. The findings from this study could lead to better treatments for those suffering from RLS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Outpatient
• • Refractory RLS defined as restless legs unresponsive to monotherapy with tolerable doses of first-line agents due to reduction in efficacy, augmentation, or adverse effects
• • IRLS score greater than 15
• Exclusion Criteria:
• • Pregnancy
• • Prescence of iron deficiency anemia
• • History of Diabetes Mellitus Type 1 and Type 2
• • History of uncontrolled hypertension
• • Presence of immunosuppression (HIV or currently taking immunosuppressants)
• • Any prior adverse reaction to glucocorticoids
• • History of dementia or major psychiatric diseases with psychosis
• • Lack of ability to understand the experimental protocol and to adequately communicate in English