Phase 2
N=12
Intravenous Iron Metabolism in Restless Legs Syndrome
Restless Legs
Bottom Line
View on ClinicalTrials.gov: NCT00685815 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Duration Off Treatment — 6; 3; 2; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ferric Carboxymaltose (FCM) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- American Regent, Inc.
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration Off Treatment |
6; 3; 2; 0; 0; 1 | — |
Summary
Double-blind, placebo-controlled, entitled: "Intravenous Iron Metabolism in Restless Legs Syndrome
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00685815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.