Intravenous Iron Metabolism in Restless Legs Syndrome

NCT00685815 | Completed Phase 2 Results DMC

• 3 other identifiers: AG01173P01AG0211901VIT06013
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Double-blind, placebo-controlled, entitled: "Intravenous Iron Metabolism in Restless Legs Syndrome

Conditions

Restless Legs

Keywords

IV Iron; Restless Legs Syndrome; RLS; Iron

Outcome Measures

Primary Outcomes (1)

• Duration Off Treatment

  Number of weeks that patients were able to remain off treatment for RLS

  2 weeks, 4 weeks, and 52 weeks

Study Arms (2)

Ferric carboxymaltose (FCM)

EXPERIMENTAL

Intravenous iron (FCM)

Drug: Ferric Carboxymaltose (FCM)

Placebo

PLACEBO COMPARATOR

normal saline

Drug: Placebo

Interventions

Ferric Carboxymaltose (FCM) DRUG

500mg FCM in 250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4

Also known as: Injectafer

Ferric carboxymaltose (FCM)

Placebo DRUG

250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4

Placebo

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of Restless Legs Syndrome (RLS).
• Presence of increased periodic leg movements of sleep (PLMS) before receiving treatment.
• Patient sleep times are between 9pm and 9am.
• Patient's RLS symptoms would occur daily if you were not on medication.

You may not qualify if:

• RLS secondary to other medical disorders as determined by history and physical/neurological examination.
• On a treatment (e.g., psychiatric medication) that might significantly alter RLS symptoms or study results and who cannot discontinue medication for the extended period of the study.
• History of multiple adverse drug reactions or specifically an allergy to IV iron.
• Currently experiencing a serious medical condition (chronic organ failure, active inflammation or infection, congestive heart failure, etc.) that might alter iron metabolism, would place them at risk, or interfere with study participation.
• An magnetic resonance imaging (MRI) is not possible because of medical reasons (Pacemaker; loose iron in the tissue) or concern about severe claustrophobia.
• Any condition that is likely to increase iron loss (chronic bleeding, excluding menstruation; medically necessary phlebotomy) or consumption (pregnancy).
• Serum ferritin \>300mg/L or percent iron saturation \>50%. This is to exclude subjects with probable hemochromatosis.
• Significant medical (e.g., inflammatory bowel syndrome; bowel dysmotility syndromes) or surgical (e.g., gastrojejunal bypass, colectomy) GI tract problems; and active chronic inflammatory processes (e.g., active hepatitis, rheumatoid arthritis, systemic lupus erythematosus). This is to exclude conditions which will potentially alter iron metabolism.

Sponsors & Collaborators

• American Regent, Inc.: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Angie Butcher
• Organization: Luitpold Pharmaceuticals, Inc.

abutcher@lpicrd.com

610-650-4200

Study Officials

• Christopher J. Earley, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2008
• First Posted: May 28, 2008
• Study Start: November 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2012
• Last Updated: May 6, 2025
• Results First Posted: May 6, 2025

Record last verified: 2020-08

Locations

US (1)