Intravenous Iron Metabolism in Restless Legs Syndrome

Restless Legs Clinical Trial

Official title:

Intravenous Iron Metabolism in Restless Legs Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685815
• Other study ID #: AG0117
• Secondary ID: 3P01AG0211901VIT
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2008
• Last updated: May 9, 2017
• Start date: November 2006
• Est. completion date: December 2012

Study information

• Verified date: May 2017
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS) symptoms and brain concentrations of iron.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Restless Legs Syndrome (RLS).

• Presence of increased 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 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, SLE). This is to exclude conditions which will potentially alter iron metabolism.

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs
• Restless Legs Syndrome

Intervention

Drug:
• Ferric Carboxymaltose (FCM)
500mg FCM in 250cc NS IV over one hour, once on Day 3, once on Day 4
• Placebo
250cc NS IV over one hour, once on Day 3, once on Day 4

Locations

Country	Name	City	State
United States	The Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's subjective report of significant RLS symptoms, obtained in a standard clinical interview		at 2 and 4 weeks after IV iron, and monthly thereafter for 2 years or until oral meds resumed