Restless Legs
Conditions
Keywords
IV Iron, Restless Legs Syndrome, RLS, Iron
Brief summary
Double-blind, placebo-controlled, entitled: Intravenous Iron Metabolism in Restless Legs Syndrome
Detailed description
To determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS) symptoms and brain concentrations of iron.
Interventions
500mg FCM in 250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4
DRUGPlacebo
250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4
Sponsors
National Institute on Aging (NIA)
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration Off Treatment | 2 weeks, 4 weeks, and 52 weeks | Number of weeks that patients were able to remain off treatment for RLS |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ferric Carboxymaltose (FCM) Intravenous Iron (FCM)
Ferric Carboxymaltose (FCM): 500mg FCM in 250cc NS IV over one hour, once on Day 3, once on Day 4 | 8 |
| Placebo Placebo
Placebo: 250cc NS IV over one hour, once on Day 3, once on Day 4 | 4 |
| Total | 12 |
Baseline characteristics
| Characteristic | Ferric Carboxymaltose (FCM) | Placebo | Total |
|---|---|---|---|
| Age, Customized 25 - 50 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Customized < 25 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Customized > 50 years | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 4 |
| other Total, other adverse events | 0 / 8 | 0 / 4 |
| serious Total, serious adverse events | 0 / 8 | 0 / 4 |
Outcome results
Primary
Duration Off Treatment
Number of weeks that patients were able to remain off treatment for RLS
Time frame: 2 weeks, 4 weeks, and 52 weeks
Population: Intent to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Duration Off Treatment | Duration - 2 weeks | 6 participants |
| Ferric Carboxymaltose (FCM) | Duration Off Treatment | Duration - 20 weeks | 2 participants |
| Ferric Carboxymaltose (FCM) | Duration Off Treatment | Duration - 52 weeks | 0 participants |
| Placebo | Duration Off Treatment | Duration - 2 weeks | 3 participants |
| Placebo | Duration Off Treatment | Duration - 20 weeks | 0 participants |
| Placebo | Duration Off Treatment | Duration - 52 weeks | 1 participants |