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

NCT ID: NCT06631300

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Prednisone group

A prednisone taper will be given to the subjects.

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

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.

Placebo group

A placebo taper will be given to match the number of pills being tapered in the prednisone group.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A placebo taper will be given to match the same number of pills administered in each stage of the prednisone taper.

Interventions

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.

Intervention Type: DRUG

Placebo

A placebo taper will be given to match the same number of pills administered in each stage of the prednisone taper.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scripps Health

OTHER

Sponsor Role: lead

Responsible Party

J STEVEN POCETA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Esguerra, MD

Role: STUDY_CHAIR

Scripps Health

Central Contacts

Steven Poceta, MD

Role: CONTACT

poceta.steven@scrippshealth.org

858-554-8895

Karen Lei, MD

Role: CONTACT

lei.karen@scrippshealth.org

Other Identifiers

IRB-24-8351

Identifier Type: -

Identifier Source: org_study_id