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Terminated Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT02826681

Public ClinicalTrials.gov record NCT02826681. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 7:40 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in Restless Legs Syndrome Patients With Iron-deficiency Anemia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02826681
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
American Regent, Inc.
Industry
Enrollment
70 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 10, 2017 (Actual)
Primary completion
Sep 4, 2021 (Actual)
Completion
Jul 1, 2022 (Actual)
Last update posted
Apr 11, 2025

2017 – 2022

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
Synergy San Diego Lemon Grove California 91945 —
Alliance for Multispeciality Research Fort Myers Florida 33912 —
CNS Healthcare Orlando Florida 32801 —
Johns Hopkins Bayview Medical Center Baltimore Maryland 21224-2780 —
Boston Neuro Research South Dartmouth Massachusetts 02169 —
Neurology Center of Las Vegas Las Vegas Nevada 89128 —
Clinical Trial Network Houston Texas 77074 —
The Polyclinic Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02826681, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 11, 2025 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02826681 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →