Mode
Text Size
Log in / Sign up
Phase 2 N=12 Randomized Double-blind Treatment

Intravenous Iron Metabolism in Restless Legs Syndrome

Restless Legs

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search