Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Treatment Phase I and II Primary Objective: To evaluate the efficacy and safety of FCM (750 mg dose x 2) for treatment of Restless Legs Syndrome (RLS) in patients with iron-deficiency anemia (IDA).

Long-Term Extension Phase III Primary Objective: To evaluate the duration of effect of prior FCM treatment and to determine the effectiveness of further iron repletion with FCM when RLS symptoms worsen or reoccur.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Ferric Compounds

Criteria

Inclusion Criteria:

1. Male or female subject ≥18 years of age who is able to give informed consent.

2. Confirmed diagnosis of RLS based on the Cambridge-Hopkins Diagnostic Questionnaire (CHDQ) and the Hopkins-Hening Telephone Diagnostic Interview (HDTI).

3. IRLSS score ≥15 plus RLS symptoms for at least 3 months and currently occurring ≥2 nights per week.

4. Iron-deficiency anemia defined as an Hgb <12 g/dl with a ferritin <20 ng/mL, or ferritin <100 when TSAT is <18%.

5. Subjects on sleep medication must be on a stable dose for at least 6 months prior screening.

6. Subjects at risk for pregnancy must have a negative pregnancy test at screening and be practicing an acceptable form of birth control, have had a hysterectomy or tubal ligation, or otherwise be incapable of pregnancy, or have practiced any of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide with barrier, intrauterine device, or partner sterility.

Exclusion Criteria:

1. Disorders that require treatment with the same medications used for RLS include:

peripheral neuropathy and neurodegenerative disorders (i.e. Parkinson's disease or dementia).

2. Current (past 4 weeks) use of drugs that may cause or treat RLS, e.g. opioids, calcium channel alpha-2-delta ligands, anti-depressants, dopaminergic agonist or antagonists, or centrally-acting antihistamines.

3. Any medical conditions contraindicated to MRI.

4. Abnormal MRI at baseline that would confound the outcome measures.

5. Secondary RLS due to neurological conditions or head trauma.

6. History of hemochromatosis, hemosiderosis, other iron storage disorders or iron metabolism disorders.

7. Women with clinically significant uterine bleeding (>200 cc blood loss) during the six months prior to screening.

8. Liver transaminases (AST or ALT) greater than two times the upper limit of normal (ULN).

9. Known positive Hepatitis B antigen (HBs Ag), unless positive test can be attributed to receipt of Hepatitis B vaccination in childhood or Hepatitis C viral antibody (HCV) with evidence of active hepatitis (i.e., AST/ALT greater than two times the ULN).

10. Known positive HIV-1 or HIV-2 antibodies (anti-HIV).

11. Active acute or known chronic infections.

12. Rheumatoid arthritis with symptoms or signs of active inflammation.

13. Pregnant and lactating women.

14. Known hypersensitivity reaction to any component of Injectafer® (ferric carboxymaltose).

15. Previously randomized to Injectafer® (FCM or VIT-45) in a clinical trial.

16. Previous IV iron treatment for RLS.

17. Parenteral iron, erythropoiesis stimulating agent use or blood transfusion within six weeks prior to the screening visit.

18. Planned elective surgery during the study year.

19. Chronic alcohol or drug abuse within the past six months.

20. Any other pre-existing laboratory abnormality, medical condition, or disease that, in the opinion of Investigator, may cause the subject to be unsuitable for the study or place the subject at potential risk from being in the study, e.g. a malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus.

21. Subject is unwilling or has conditions that would prohibit them from complying with the study requirements.