Restless leg syndorme
Conditions
Interventions
Trade Name: Monofer 100mg/ml
Lösung zur Injektion und Infusion
Pharmaceutical Form: Infusion
INN or Proposed INN: Ferric derisomaltose
Other descriptive name: Monofer 100mg/ml solution for injection/i
Sponsors
Medical University of Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. RLS diagnosed according to the current IRLSSG criteria Essential diagnostic criteria (all must be met): - An urge to move the legs usually but not always accompanied by, or felt to be caused by, uncomfortable and unpleasant sensations in the legs. - The urge to move the legs and any accompanying unpleasant sensations begin or worsen during periods of rest or inactivity such as lying down or sitting. - The urge to move the legs and any accompanying unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues. - The urge to move the legs and any accompanying unpleasant sensations during rest or inactivity only occur or are worse in the evening or night than during the day. - The occurrence of the above features is not solely accounted for as symptoms primary to another medical or a behavioral condition (e.g. myalgia, venous stasis, leg edema, arthritis, leg cramps, positional discomfort, habitual foot tapping). 2. Female and male participants aged = 18 years 3. Negative urine/serum pregnancy test in women of childbearing potential (WOCBP, see section 7.6). WOCBP who are sexually active, agree to use highly effective means of contraception during the study and for at least 1 month post-study treatment. Allowed are accepted and effective hormonal/non-hormonal methods of contraception and sexual abstinence or vasectomised partners (> 3 months previously). Vasectomy has to be confirmed by two negative semen analyses. 4. Written, signed and dated informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Secondary RLS 2. Sporadic RLS 3. Dialysis-dependent renal failure (eGFR 200 mg/dL or Transferrin Saturation over 45% 11. Phosphate levels below the lower limit normal before study drug initiation. 12. Contraindications for performing a MRI (for example claustrophobia, pacemakers, metal implants). 13. Body weight < 50 kg 14. Known Hypersensitivity to the active substance or any of its excipients (Sodium hydroxide/Hydrochloric acid) 15. Participating in another interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives are to investigate the effect of iron supplementation a. on clinical RLS symptoms measured by other validated scales, b. on the mitochondrial respiration and serological biomarkers, and c. on iron content in the substantia nigra.;Primary end point(s): - Changes in RLS severity as detected by the IRLS ;Timepoint(s) of evaluation of this end point: at the end of trial;Main Objective: Primary objective of this study is to investigate the effect of iron supplementation or placebo (in combination or not with dopaminergic therapy) on clinical RLS symptoms measured by the IRLS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Changes in RLS severity as detected by the sIRLS, RLS-6 and CGI 2. Changes in blood count, iron, Tf, TSAT, ferritin, sTfR, hepcidin-25, creatinine (GFR), GPT, GOT, LDH, CRP, electrolytes (Na, K, P, Ca), PTH, LCN2, dopamine, 1,25-(OH)2 vitamin D, 25-OH vitamin D, EPO, ERFE, PDGF-BB, LCN2 and metabolites (ATP, NADH/NAD, Lactate, Succinate, Citrate, Pyruvate, free fatty acids) 3. Changes in mitochondrial iron and Krebs cycle metabolism gene expression in monocytes detected by RT-PCR 4. Changes in mitochondrial respiration of selected and randomly assigned patients measured with OROBOROS respirometry 5. Changes in iron content in the substantia nigra detected by an MRI in a subgroup of 80 patients (20 dopaminergic therapy/iron, 20 dopaminergic therapy/placebo, 20 no previous treatment/iron and 20 no previous treatment/placebo);Timepoint(s) of evaluation of this end point: at the end of trial | — |
Countries
Austria
Contacts
Public ContactKompetenzzentrum Klinische Studien
Medical University
Outcome results
None listed