Restless LegsPhase 2RLSNCT00685815
Intravenous Iron Metabolism in Restless Legs Syndrome
A Phase 2 study testing Ferric Carboxymaltose (FCM) in people with Restless Legs, run by American Regent, Inc. at 1 site in United States.
Trial summary
Double-blind, placebo-controlled, entitled: "Intravenous Iron Metabolism in Restless Legs Syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs
- What is being tested?
- Ferric Carboxymaltose (FCM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Double-blind, placebo-controlled, entitled: "Intravenous Iron Metabolism in Restless Legs Syndrome
Read the detailed description
To determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS) symptoms and brain concentrations of iron.
- Conditions
- Restless Legs
- Being tested
- Ferric Carboxymaltose (FCM), Placebo
- Keywords
- IV Iron, Restless Legs Syndrome, RLS, Iron
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Carboxymaltose (FCM)Drug
Also called Injectafer
500mg FCM in 250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4
PlaceboDrug
250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4
| Study group | Role | What they receive |
|---|---|---|
| Ferric carboxymaltose (FCM) | Experimental | Intravenous iron (FCM) Receives: Drug: Ferric Carboxymaltose (FCM) |
| Placebo | Placebo comparator | normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration Off Treatment
Number of weeks that patients were able to remain off treatment for RLS
Measured: 2 weeks, 4 weeks, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startNov 2006
- Primary completionDec 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Restless LegsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Christopher J. Earley, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685815
- Sponsor's protocol ID
- AG0117
- Other IDs
- 3P01AG021190, 1VIT06013
- Acronym
- RLS
- Status last verified
- Aug 2020
- First submitted
- 23 May 2008
- Last updated
- 6 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Iron Metabolism in Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT00685815
- Acronym / sponsor ID
- RLS / AG0117
- Conditions
- Restless Legs
- Keywords
- IV Iron, Restless Legs Syndrome, RLS, Iron
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Nov 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 May 2008 (estimated)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric carboxymaltose (FCM) | Experimental | Drug: Ferric Carboxymaltose (FCM)Intravenous iron (FCM) |
| Placebo | Placebo comparator | Drug: Placebonormal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Carboxymaltose (FCM)Also: Injectafer500mg FCM in 250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4 | Drug | Ferric carboxymaltose (FCM) |
| Placebo250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4 | Drug | Placebo |
Primary outcome
Duration Off Treatment
Time frame: 2 weeks, 4 weeks, and 52 weeks
Number of weeks that patients were able to remain off treatment for RLS
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J. Earley, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ferric Carboxymaltose (FCM) in people with Restless Legs, run by American Regent, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration Off Treatment (time frame: 2 weeks, 4 weeks, and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.