Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS

Inclusion Criteria:

1. Male or female subject's ≥18 years of age, willing and able to give informed consentto the study.
2. RLS symptoms affirming diagnosis. The IRLS Diagnostic Criteria must be met:
3. An urge (distressing need) to move the legs usually associated with painful oruncomfortable sensations in the legs. The urge to move may be present without theuncomfortable sensations. The arms or other body parts may be involved inaddition to the legs.
4. The urge to move or unpleasant sensations are worse or exclusively present atrest or inactivity, such as lying down or sitting.
5. The urge to move or unpleasant sensations are partially/temporarily relieved withwalking or moving the legs.
6. The urge to move or unpleasant sensations are worse in the evening or night thanduring the day or only occur in the evening or night. When symptoms are severe,the worsening at night may not be noticeable but must have been previouslypresent.
7. Subjects should be on monotherapy for RLS. Treatment should be stable for at least 8weeks prior to screening (See approved RLS Therapies/Regimen in Appendix III).
8. A score ≥15 on the IRLS Rating Scale at screening and on Day 0 prior to dosing.
9. Subjects on anti-depressants and sleep medications must be on a stable dose for atleast 6 months.
10. Subject has regular sleep hours between 9 pm and 9 am.
11. Subjects at risk for pregnancy must have a negative pregnancy test at baseline and bepracticing an acceptable form of birth control: have had a hysterectomy or tuballigation, or otherwise be incapable of pregnancy, or have practiced any of thefollowing methods of contraception for at least one month prior to study entry:hormonal contraceptives, spermicide with barrier, intrauterine device, or partnersterility.

Exclusion Criteria:

1. RLS 2° to other disease or injury.
2. Disorders that require treatment with the same medications used for RLS include:peripheral neuropathy and neurodegenerative disorders (i.e. Parkinson's Disease orDementia).
3. Stage 4 - 5 CKD, subjects on dialysis or anticipated to start dialysis whileparticipating in this study.
4. Any pain related (e.g., frequent muscle cramps, myalgia, fibromyalgia) or sleeprelated disorders (e.g. sleep apnea, unless on stable Continuous Positive AirwayPressure [CPAP]) which may confound the outcome measures.
5. Subjects with multiple sclerosis.
6. History of neuroleptic akathisia.
7. Parenteral iron use within 6 weeks prior to screening.
8. History of >10 blood transfusions in the past 2 years.
9. Anticipated need for blood transfusion during the study.
10. Known hypersensitivity reaction to any component of Injectafer® (FerricCarboxymaltose).
11. Previously randomized to Injectafer® (FCM or VIT-45) in a clinical trial.
12. Current, active or acute or chronic infection other than viral upper respiratory tractinfection
13. Malignancy (other than basal or squamous cell skin cancer or the subject has beencancer free for ≥ 5 years).
14. Pregnant or lactating women.
15. Seizure disorder currently being treated with medication.
16. Baseline ferritin ≥300 ng/mL.
17. Baseline TSAT ≥45%.
18. History of hemochromatosis, hemosiderosis, or other iron storage disorders.
19. AST or ALT greater than 2 times the upper limit of normal (ULN).
20. Hemoglobin greater than the ULN.
21. Known positive hepatitis B antigen (HBsAg), unless positive test can be attributed toreceipt of hepatitis B vaccination in childhood or hepatitis C viral antibody (HCV)with evidence of active hepatitis (i.e., AST/ALT greater than the upper limit ofnormal).
22. Known positive HIV-1/HIV-2 antibodies (anti-HIV).
23. Received an investigational drug within 30 days before randomization.
24. Chronic alcohol or drug abuse within the past 6 months.
25. Any other pre-existing laboratory abnormality, medical condition or disease, which perthe investigator may put the subject at risk if they participate in the study.
26. Subject unable or unwilling to comply with the study requirements.