Restless Legs Syndrome (RLS)Phase 2NCT01382901
Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)
A Phase 2 study testing Ferric Carboxymaltose (FCM) in people with Restless Legs Syndrome (RLS), run by American Regent, Inc..
Trial summary
The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous (IV) iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless Legs Syndrome (RLS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome (RLS)
- What is being tested?
- Ferric Carboxymaltose (FCM)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Jul 2007
- 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
- Male or female subjects > or = to 18 years old, and able to give informed consent to the study.
- RLS signs and symptoms affirming diagnosis. The IRLS Diagnostic Criteria for RLS must be met.
- Subjects have RLS symptoms > or = to 5 nights per week for at least the past 3 months.
- A baseline score > or = to 15 on the IRLS Rating Scale.
- At least one leg with an average baseline Periodic Leg Movement while asleep (PLMS) > or = to 15 movements per hour and at least 3 days of baseline PLMS data is measurable in each leg.
- Subjects on anti-depressants, sleep medications, dopamine agonists, benzodiazepines, narcotics or other RLS treatments must be off therapy at least one week or 5 half lives, whichever is longer before any baseline RLS assessments and PLM measurements are obtained.
- Subject has regular sleep hours between 9 p.m. and 9 a.m.
- Subjects at risk for pregnancy must have a negative pregnancy test at baseline and be practicing an acceptable form of birth control.
Who cannot join
- RLS 2° to other CNS disease or injury. Such disorders include peripheral neuropathy, neurodegenerative disorders, and multiple sclerosis.
- RLS 2° to Chronic Kidney Disease.
- Any pain related or sleep related disorders (e.g. sleep apnea) which may confound the outcome measures.
- History of neuroleptic akathisia.
- Oral iron use (including multivitamins with iron) after screening.
- Parenteral iron use within 4 weeks prior to screening.
Show all 31Show fewer
- Parenteral iron use > 125 mg per week within 4 to 8 weeks prior to screening.
- History of > or = to 10 blood transfusions in the past 2 years.
- Anticipated need for blood transfusion during the study.
- Known hypersensitivity reaction to any component to FCM.
- Previously participated in an FCM clinical trial.
- Chronic or serious active severe infection.
- Malignancy (other than basal or squamous cell skin cancer or the subject has been cancer free for > 5 years).
- Active inflammatory arthritis (e.g. rheumatoid arthritis, SLE).
- Receiving prescription medication for the treatment of bronchospasm.
- Pregnant or lactating women.
- Severe peripheral vascular disease with significant skin changes.
- Seizure disorder currently being treated with medication.
- Baseline ferritin > 300 ng/mL.
- Baseline TSAT > or = to 45%.
- History of hemochromatosis or hemosiderosis or other iron storage disorders.
- AST or ALT greater than the upper limit of normal.
- Hemoglobin greater than the upper limit of normal.
- Calcium or phosphorous outside the normal range.
- Known positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis.
- Known positive HIV-1/HIV-2 antibodies (anti-HIV).
- Received an investigational drug within 30 days before randomization.
- Chronic alcohol or drug abuse within the past 6 months.
- Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) III or IV, or poorly controlled hypertension according to the judgment of the investigator.
- Any other pre-existing laboratory abnormality, medical condition or disease which in view of the investigator participation in this study may put the subject at risk.
- Subject unable to comply with study requirements.
About this study
Official title: A Phase 2a Study Evaluating the Efficacy and Safety of a Novel Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)
The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous (IV) iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless Legs Syndrome (RLS)
- Conditions
- Restless Legs Syndrome (RLS)
- Being tested
- Ferric Carboxymaltose (FCM), Placebo
- 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 VIT-45
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Intravenous (IV) Iron | Experimental | Not described Receives: Drug: Ferric Carboxymaltose (FCM) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Restless Legs Syndrome (IRLS) Total Score
The scale represents the patients symptoms of RLS. The patient rates his/her symptoms based on 10 questions with a maximum possible score of 40 representing the most severe symptoms while a score of 0 represents no symptoms at all.
Measured: Change from Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMar 2006
- Primary completionJul 2007
- Study completionJul 2007
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 Legs Syndrome (RLS)Studies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382901
- Sponsor's protocol ID
- 1VIT05009
- Status last verified
- Jan 2018
- First submitted
- 23 Feb 2011
- Last updated
- 20 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study Evaluating the Efficacy and Safety of a Novel Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)
- ClinicalTrials.gov ID
- NCT01382901
- Acronym / sponsor ID
- 1VIT05009
- Conditions
- Restless Legs Syndrome (RLS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 27 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous (IV) iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless Legs Syndrome (RLS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous (IV) Iron | Experimental | Drug: Ferric Carboxymaltose (FCM) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects > or = to 18 years old, and able to give informed consent to the study.
- RLS signs and symptoms affirming diagnosis. The IRLS Diagnostic Criteria for RLS must be met.
- Subjects have RLS symptoms > or = to 5 nights per week for at least the past 3 months.
- A baseline score > or = to 15 on the IRLS Rating Scale.
- At least one leg with an average baseline Periodic Leg Movement while asleep (PLMS) > or = to 15 movements per hour and at least 3 days of baseline PLMS data is measurable in each leg.
Key exclusion criteria (31 listed)
- RLS 2° to other CNS disease or injury. Such disorders include peripheral neuropathy, neurodegenerative disorders, and multiple sclerosis.
- RLS 2° to Chronic Kidney Disease.
- Any pain related or sleep related disorders (e.g. sleep apnea) which may confound the outcome measures.
- History of neuroleptic akathisia.
- Oral iron use (including multivitamins with iron) after screening.
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: VIT-45 | Drug | Intravenous (IV) Iron |
| Placebo | Drug | Placebo |
Primary outcome
International Restless Legs Syndrome (IRLS) Total Score
Time frame: Change from Baseline to Day 28
The scale represents the patients symptoms of RLS. The patient rates his/her symptoms based on 10 questions with a maximum possible score of 40 representing the most severe symptoms while a score of 0 represents no symptoms at all.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ferric Carboxymaltose (FCM) in people with Restless Legs Syndrome (RLS), run by American Regent, Inc..
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 8 inclusion and 31 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 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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 27 Jun 2011). 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?
International Restless Legs Syndrome (IRLS) Total Score (time frame: Change from Baseline to Day 28). 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 20 Feb 2018.