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

NCT06631300 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB-24-8351
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Keywords

refractory rls; rls; restless legs syndrome

Outcome Measures

Primary Outcomes (2)

• International Restless Legs Syndrome Study Group rating scale (IRLS)

  Evaluates severity of restless legs syndrome symptoms

  Taken on Day 0, Day 14, and Day 21

• Clinical Global Impression (CGI)

  Participant quantifies overall severity of illness before and after intervention

  Taken on Day 0 and Day 21

Secondary Outcomes (5)

• Epworth Sleepiness Scale (ESS)

  Taken on Day 0 and Day 21

• Insomnia Severity Index (ISI)

  Taken on Day 0 and Day 21

• Hepcidin levels

  Taken on Day 0 and Day 21

• Fitbit Sleep Score

  Taken on Day 0 through Day 21

• Generic Assessment of Side Effects (GASE)

  Taken on Day 14, Day 21 and Day 35

Study Arms (2)

Prednisone group

EXPERIMENTAL

A prednisone taper will be given to the subjects.

Drug: Prednisone

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Prednisone 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.

Prednisone group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scripps Health: lead

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mark Esguerra, MD

  Scripps Health

  STUDY CHAIR

Central Study Contacts

Steven Poceta, MD

CONTACT

858-554-8895; poceta.steven@scrippshealth.org

Karen Lei, MD

CONTACT

lei.karen@scrippshealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 8, 2024
• Study Start: October 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share