Who is sponsoring NCT02826681?

NCT02826681 is sponsored by American Regent, Inc..

What drugs are being tested in NCT02826681?

Interventions in NCT02826681: Injectafer® (Ferric Carboxymaltose - FCM), Placebo (Normal Saline).

What condition does NCT02826681 study?

NCT02826681 studies Restless Legs Syndrome (RLS).

Is NCT02826681 still recruiting?

NCT02826681 is currently terminated. Last updated 11 April 2025.

Are results published for NCT02826681?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-04-11 · How we verify

NCT02826681

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Results posted Last updated 11 April 2025

What this trial tests

Phase 2 trial testing Injectafer® (Ferric Carboxymaltose - FCM) in Restless Legs Syndrome (RLS) in 70 participants. Terminated before completion.

Timeline

10 July 2017

Primary endpoint
4 September 2021

1 July 2022

Quick facts

Lead sponsor	American Regent, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	70
Start date	10 July 2017
Primary completion	4 September 2021
Estimated completion	1 July 2022
Sites	8 locations across United States

Drugs / interventions tested

Injectafer® (Ferric Carboxymaltose - FCM) — full drug profile →
Placebo (Normal Saline)

Conditions studied

Restless Legs Syndrome (RLS) — all drugs for Restless Legs Syndrome (RLS) →

Sponsor

American Regent, Inc. — full company profile →

Who can join

18 and older, any sex, with Restless Legs Syndrome (RLS). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Treatment Phase I: IRLSS Score Change Primary · Baseline to Day 42

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

Group	Value	95% CI
Injectafer	12
Normal Saline	12

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Iron for the treatment of restless legs syndrome.
Trotti LM, Becker LA. · · 2019 · cited 27× · PMID 30609006 · DOI 10.1002/14651858.cd007834.pub3

Verify or expand the search:

Other American Regent, Inc. trials

Trials by the same sponsor.

NCT05661682 — Tralement Versus a Fixed-dose Trace Element Combination Product to Evaluate Manganese Safety · Phase 4 · withdrawn
NCT04968379 — Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia · Phase 2 · withdrawn
NCT04269707 — Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfa · Phase 3 · completed
NCT03523117 — Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA · Phase 3 · completed
NCT03037931 — Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02826681 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by American Regent, Inc.
Last refreshed: 11 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02826681.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing