Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631300
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-06
Brief Title:
A Randomized Placebo-controlled Trial of Prednisone in Refractory Restless Legs Syndrome a Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Placebo-controlled Trial of Prednisone in Refractory Restless Legs Syndrome a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PrRLS
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None