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

NCT ID: NCT02397057

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-01-31

Brief Summary

This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 12 months. The subject's participation in the study will be for approximately 1 year from Day 0.

Detailed Description

This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 12 months. Subjects will visit the clinic on Days 0 and 5 for treatment, and then on Days 14, 42, 168, and 365. In between the clinic visits subjects will be contacted remotely on Days 84, 126, 210, 252, 294, and 336. The subject's participation in the study will be for approximately 1 year from Day 0.

Conditions

Restless Legs Syndrome (RLS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Injectafer

Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.

Group Type: ACTIVE_COMPARATOR

Injectafer

Intervention Type: DRUG

Normal Saline

IV Placebo (15ml of Normal Saline) IV push at 2ml/minute

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Injectafer

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Other Intervention Names

Ferinject®; Iroprem®; Renegy®; Normal Saline

Eligibility Criteria

Inclusion Criteria

1. Male or female subject's ≥18 years of age, willing and able to give informed consent to the study.

2. RLS symptoms affirming diagnosis. The IRLS Diagnostic Criteria must be met:

1. An urge (distressing need) to move the legs usually associated with painful or uncomfortable sensations in the legs. The urge to move may be present without the uncomfortable sensations. The arms or other body parts may be involved in addition to the legs.

2. The urge to move or unpleasant sensations are worse or exclusively present at rest or inactivity, such as lying down or sitting.

3. The urge to move or unpleasant sensations are partially/temporarily relieved with walking or moving the legs.

4. The urge to move or unpleasant sensations are worse in the evening or night than during 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 previously present.

3. Subjects should be on monotherapy for RLS. Treatment should be stable for at least 8 weeks prior to screening (See approved RLS Therapies/Regimen in Appendix III).

4. A score ≥15 on the IRLS Rating Scale at screening and on Day 0 prior to dosing.

5. Subjects on anti-depressants and sleep medications must be on a stable dose for at least 6 months.

6. Subject has regular sleep hours between 9 pm and 9 am.

7. Subjects at risk for pregnancy must have a negative pregnancy test at baseline 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. 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 or Dementia).

3. Stage 4 - 5 CKD, subjects on dialysis or anticipated to start dialysis while participating in this study.

4. Any pain related (e.g., frequent muscle cramps, myalgia, fibromyalgia) or sleep related disorders (e.g. sleep apnea, unless on stable Continuous Positive Airway Pressure [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® (Ferric Carboxymaltose).

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 tract infection

13. Malignancy (other than basal or squamous cell skin cancer or the subject has been cancer 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 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 the upper limit of normal).

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 per the investigator may put the subject at risk if they participate in the study.

26. Subject unable or unwilling to comply with the study requirements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Regent, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Falone, MD

Role: STUDY_DIRECTOR

American Regent, Inc.

Locations

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Synergy San Diego

National City, California, United States

Desert Valley Research

Rancho Mirage, California, United States

Anderson Clinical Research

Redlands, California, United States

Neurology Offices of South FL

Boca Raton, Florida, United States

Elite Research Institute

Miami, Florida, United States

MidAmmerica Neuroscience Institute

Lenexa, Kansas, United States

Central Kentucky Research Assoc., Inc.

Lexington, Kentucky, United States

Neuromedical Clinical of Central Louisiana

Alexandria, Louisiana, United States

Ctr for Brain & Neuro Care, LLC

Fulton, Maryland, United States

Massachusetts General Hospital, Sleep Disorders Clinical Research Program

Boston, Massachusetts, United States

Desert Neurology

Las Vegas, Nevada, United States

Neurology Center of Las Vegas

Las Vegas, Nevada, United States

Guilford Neurologic Associates

Greensboro, North Carolina, United States

Metrolina Neurological Associates

Old Point Station, South Carolina, United States

Saad Upstate Neurology

Spartanburg, South Carolina, United States

Tri-State Mountain Neurology Associates

Johnson City, Tennessee, United States

Egret Bay Neurology

Houston, Texas, United States

The Polyclinic, Madison Center

Seattle, Washington, United States

Countries

United States

References

Earley CJ, Garcia-Borreguero D, Falone M, Winkelman JW. Clinical efficacy and safety of intravenous ferric carboxymaltose for treatment of restless legs syndrome: a multicenter, randomized, placebo-controlled clinical trial. Sleep. 2024 Jul 11;47(7):zsae095. doi: 10.1093/sleep/zsae095.

Reference Type: DERIVED

PMID: 38625730 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1VIT14037

Identifier Type: -

Identifier Source: org_study_id