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NCT06631300: PrRLS
A Randomized, Placebo-controlled Trial of Prednisone in Refractory Restless Legs Syndrome: a Pilot Study
Phase 1, PHASE2 trial testing Prednisone in Restless Legs Syndrome in 50 participants. Not yet recruiting.
1 June 2025
Quick facts
| Lead sponsor | Scripps Health |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 October 2024 |
| Primary completion | 1 June 2025 |
| Estimated completion | 31 December 2025 |
Drugs / interventions tested
- Prednisone (prednisone) — full drug profile →
- Placebo
Conditions studied
- Restless Legs Syndrome — all drugs for Restless Legs Syndrome →
Sponsor
Scripps Health — full company profile →
Who can join
Adults 18 to 80, any sex, with Restless Legs Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06631300
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Restless Legs Syndrome
Currently open trials in the same condition.
- NCT06889324 — Efficacy of Vibration Therapy on Restless Legs Syndrome and Sleep Disturbances Among Patients Undergoing Hemodialysis · NA · active not recruiting
- NCT06866132 — Response to an Investigational Device in Patients With Restless Legs Syndrome · NA · active not recruiting
- NCT06684782 — Prevalence and Characteristics of Restless Leg Syndrome in Thai Patients With Parkinson's Disease · recruiting
- NCT06806891 — Restless Leg Syndrome: Is There a Response to Buddhist Walking Meditation in Hemodialysis · NA · recruiting
- NCT06570941 — Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome · Phase 1, PHASE2 · active not recruiting
Other Scripps Health trials
Trials by the same sponsor.
- NCT06590285 — Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation · NA · recruiting
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- NCT05611749 — Duloxetine Impact on Postoperative Pain Control and Outcomes · Phase 2 · terminated
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06631300 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Scripps Health
- Last refreshed: 8 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06631300.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing