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NCT02826681 · ClinicalTrials.gov registry record · Phase 2
Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia
A Phase 2 study, sponsored by American Regent.
- Terminated
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT02826681: Clinical Trial Phase 2 study, sponsored by American Regent.
NCT02826681 is a Phase 2 study that was terminated before completion, run by American Regent. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02826681, a Phase 2 study, was terminated before completion, sponsored by American Regent.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study 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.
Primary Outcome
IRLSS (International Restless Legs Syndrome Severity Scale) score change from baseline to Day 42 with comparison between FCM (Ferric Carboxymaltose) vs. Placebo.
Interventions
- DRUG Placebo (Normal Saline)
- DRUG Injectafer® (Ferric Carboxymaltose - FCM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2017-07-10 |
| Est. Completion | 2022-07-01 |
| Phase | Phase 2 |
Why NCT02826681 stopped before completion
NCT02826681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo (Normal Saline) is the first listed.
NCT02826681 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02826681 about?
NCT02826681 is a clinical study titled "Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia". 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 trea...
What is the current status of trial NCT02826681?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2017-07-10. Estimated completion is 2022-07-01.
What interventions are being tested in trial NCT02826681?
The interventions under investigation include: Placebo (Normal Saline) (DRUG), Injectafer® (Ferric Carboxymaltose - FCM) (DRUG).
Who is sponsoring clinical trial NCT02826681?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02826681's enrollment target sits among peer trials
70 937th of 2000 higher than 1,036 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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