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

NCT02826681 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 1VIT15042
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Restless Legs Syndrome (RLS)

Outcome Measures

Primary Outcomes (1)

• Treatment Phase I: IRLSS Score Change

  IRLSS (International Restless Legs Syndrome Severity Scale) score change from baseline to Day 42 with comparison between FCM (Ferric Carboxymaltose) vs. Placebo.

  Baseline to Day 42

Study Arms (2)

Injectafer

ACTIVE COMPARATOR

750 mg undiluted slow IVpush (100 mg/minute) of Injectafer® (Ferric Carboxymaltose - FCM)

Drug: Injectafer® (Ferric Carboxymaltose - FCM)

Normal Saline

PLACEBO COMPARATOR

Placebo (15 ml of Normal Saline \[NS\]) IV push at 2 ml/minute on Day 0 and 7.

Drug: Placebo (Normal Saline)

Interventions

Injectafer® (Ferric Carboxymaltose - FCM) DRUG

Intravenous Iron

Also known as: Ferinject®, Iroprem®, Renegy®

Injectafer

Placebo (Normal Saline) DRUG

Normal Saline Solution

Also known as: Normal Saline

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject ≥18 years of age who is able to give informed consent.
• Confirmed diagnosis of RLS based on the Cambridge-Hopkins Diagnostic Questionnaire (CHDQ) and the Hopkins-Hening Telephone Diagnostic Interview (HDTI).
• IRLSS score ≥15 plus RLS symptoms for at least 3 months and currently occurring ≥2 nights per week.
• Iron-deficiency anemia defined as an Hgb \<12 g/dl with a ferritin \<20 ng/mL, or ferritin \<100 when TSAT is \<18%.
• Subjects on sleep medication must be on a stable dose for at least 6 months prior screening.
• 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.

You may not qualify if:

• Disorders that require treatment with the same medications used for RLS include:
• peripheral neuropathy and neurodegenerative disorders (i.e. Parkinson's disease or dementia).
• 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.
• Any medical conditions contraindicated to MRI.
• Abnormal MRI at baseline that would confound the outcome measures.
• Secondary RLS due to neurological conditions or head trauma.
• History of hemochromatosis, hemosiderosis, other iron storage disorders or iron metabolism disorders.
• Women with clinically significant uterine bleeding (\>200 cc blood loss) during the six months prior to screening.
• Liver transaminases (AST or ALT) greater than two times the upper limit of normal (ULN).
• 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).
• Known positive HIV-1 or HIV-2 antibodies (anti-HIV).
• Active acute or known chronic infections.
• Rheumatoid arthritis with symptoms or signs of active inflammation.
• Pregnant and lactating women.
• Known hypersensitivity reaction to any component of Injectafer® (ferric carboxymaltose).

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (8)

Synergy San Diego

Lemon Grove, California, 91945, United States

Location

Alliance for Multispeciality Research

Fort Myers, Florida, 33912, United States

Location

CNS Healthcare

Orlando, Florida, 32801, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224-2780, United States

Location

Boston Neuro Research

South Dartmouth, Massachusetts, 02169, United States

Location

Neurology Center of Las Vegas

Las Vegas, Nevada, 89128, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

The Polyclinic

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

ferric carboxymaltose; Saline Solution

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Mark Falone
• Organization: American Regent, Inc.

mfalone@americanregent.com

631.772.3544

Study Officials

• Khaled Khechen, MD

  American Regent

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 11, 2016
• Study Start: July 10, 2017
• Primary Completion: September 4, 2021
• Study Completion: July 1, 2022
• Last Updated: April 11, 2025
• Results First Posted: September 14, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)