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

NCT02397057 | Completed Phase 3 Results

• 1 other identifier: 1VIT14037
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 19

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.

Conditions

Restless Legs Syndrome (RLS)

Outcome Measures

Primary Outcomes (2)

• International Restless Legs Syndrome (IRLS) Total Score Change From Baseline on Day 42

  Summary of the actual values of IRLS total score on baseline and Day 42, and the change from baseline to Day 42. Eligible subjects were to have met the following requirements prior to receiving additional treatment: A baseline score ≥ 15 on the International Restless Legs Syndrome (IRLS) Rating Scale. The minimum score is 15 with the maximum of 40. A score of less than 15 is not an indicator of RLS. However, a score of 15 or greater is an indicator of RLS. Further increase indicates more severe disease.

  Baseline and Day 42

• Proportion of Patients Rated as Much or Very Much Improved With the Clinical Global Impression (CGI) Performed by Investigator (CGI-I)

  Responder is defined as subjects rated as much or very much improved with the CGI-I on Day 42. Summary of the number (percentage) of CGI-I responder. Per the protocol, the he CGI is a 3-item observer-rated scale that measures illness severity (CGIS), global improvement or change (CGIC) and therapeutic response. The scale requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.

  Day 42

Secondary Outcomes (5)

• Clinical Global Impression-Improvement (CGI-S) by Subject

  Day 42

• Restless Legs Syndrome Quality of Life (RLS-QLI) Change From Baseline to Day 42.

  Baseline and Day 42

• Fatigue Linear Analog Scale Change From Baseline

  Baseline and Day 42

• Medical Outcomes Study(MOS) Sleep Scale Change From Baseline to Day 42

  Change from Baseline and Day 42.

• Time Off Pre-Enrollment Prescribed Restless Legs Syndrome (RLS) Medications

  Time from Day 5 to Day 365

Study Arms (2)

Injectafer

ACTIVE COMPARATOR

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

Drug: Injectafer

Normal Saline

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Injectafer DRUG

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

Injectafer

Placebo OTHER

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's ≥18 years of age, willing and able to give informed consent to the study.
• RLS symptoms affirming diagnosis. The IRLS Diagnostic Criteria must be met:
• 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.
• The urge to move or unpleasant sensations are worse or exclusively present at rest or inactivity, such as lying down or sitting.
• The urge to move or unpleasant sensations are partially/temporarily relieved with walking or moving the legs.
• 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.
• 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).
• A score ≥15 on the IRLS Rating Scale at screening and on Day 0 prior to dosing.
• Subjects on anti-depressants and sleep medications must be on a stable dose for at least 6 months.
• Subject has regular sleep hours between 9 pm and 9 am.
• 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.

You may not qualify if:

• RLS 2° to other disease or injury.
• Disorders that require treatment with the same medications used for RLS include: peripheral neuropathy and neurodegenerative disorders (i.e. Parkinson's Disease or Dementia).
• Stage 4 - 5 CKD, subjects on dialysis or anticipated to start dialysis while participating in this study.
• 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.
• Subjects with multiple sclerosis.
• History of neuroleptic akathisia.
• Parenteral iron use within 6 weeks prior to screening.
• History of \>10 blood transfusions in the past 2 years.
• Anticipated need for blood transfusion during the study.
• Known hypersensitivity reaction to any component of Injectafer® (Ferric Carboxymaltose).
• Previously randomized to Injectafer® (FCM or VIT-45) in a clinical trial.
• Current, active or acute or chronic infection other than viral upper respiratory tract infection
• Malignancy (other than basal or squamous cell skin cancer or the subject has been cancer free for ≥ 5 years).
• Pregnant or lactating women.
• Seizure disorder currently being treated with medication.

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (19)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Synergy San Diego

National City, California, 91950, United States

Location

Desert Valley Research

Rancho Mirage, California, 92270, United States

Location

Anderson Clinical Research

Redlands, California, 92374, United States

Location

Neurology Offices of South FL

Boca Raton, Florida, 33428, United States

Location

Elite Research Institute

Miami, Florida, 33169, United States

Location

MidAmmerica Neuroscience Institute

Lenexa, Kansas, 66214-1505, United States

Location

Central Kentucky Research Assoc., Inc.

Lexington, Kentucky, 40509, United States

Location

Neuromedical Clinical of Central Louisiana

Alexandria, Louisiana, 71301, United States

Location

Ctr for Brain & Neuro Care, LLC

Fulton, Maryland, 20759, United States

Location

Massachusetts General Hospital, Sleep Disorders Clinical Research Program

Boston, Massachusetts, 02114, United States

Location

Desert Neurology

Las Vegas, Nevada, 89119, United States

Location

Neurology Center of Las Vegas

Las Vegas, Nevada, 89128, United States

Location

Guilford Neurologic Associates

Greensboro, North Carolina, 27405, United States

Location

Metrolina Neurological Associates

Old Point Station, South Carolina, 29707, United States

Location

Saad Upstate Neurology

Spartanburg, South Carolina, 29307, United States

Location

Tri-State Mountain Neurology Associates

Johnson City, Tennessee, 37604, United States

Location

Egret Bay Neurology

Houston, Texas, 77058, United States

Location

The Polyclinic, Madison Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 38625730 DERIVED

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 A. Falone, MD MPH
• Organization: American Regent, Inc

mfalone@americanregent.com

6317723544

Study Officials

• Mark Falone, MD

  American Regent, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 24, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-10

Locations

US (19)