Restless Legs Syndrome
Conditions
Keywords
refractory rls, rls, restless legs syndrome
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.
Interventions
DRUGPrednisone
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.
DRUGPlacebo
A placebo taper will be given to match the same number of pills administered in each stage of the prednisone taper.
Sponsors
Scripps Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Restless Legs Syndrome Study Group rating scale (IRLS) | Taken on Day 0, Day 14, and Day 21 | Evaluates severity of restless legs syndrome symptoms |
| Clinical Global Impression (CGI) | Taken on Day 0 and Day 21 | Participant quantifies overall severity of illness before and after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hepcidin levels | Taken on Day 0 and Day 21 | Measures serum hepcidin levels |
| Epworth Sleepiness Scale (ESS) | Taken on Day 0 and Day 21 | Subjective measure of participant's sleepiness |
| Generic Assessment of Side Effects (GASE) | Taken on Day 14, Day 21 and Day 35 | Monitors for study related complications |
| Fitbit Sleep Score | Taken on Day 0 through Day 21 | Composite of sleep duration, sleep quality, and restoration as measured on Fitbit device based on heart rate variability |
| Insomnia Severity Index (ISI) | Taken on Day 0 and Day 21 | Quantifies participant's perception of insomnia severity |
Contacts
Primary ContactSteven Poceta, MD
Backup ContactKaren Lei, MD
Outcome results
None listed