Restless Legs SyndromePhase 2NCT00895232
Iron Sucrose In The Treatment of Restless Legs Syndrome: Safety of Three Dose Regimens as Evaluated by Clinical Assessments
A Phase 2 study testing Cohort I, Cohort II and Cohort III in people with Restless Legs Syndrome, run by American Regent, Inc..
Trial summary
Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS were assigned to 1 of 3 treatment cohorts. The first cohort received one 500 mg IV iron sucrose infusion in 500 mL normal sterile saline (NSS) administered over four hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Cohort I, Cohort II and Cohort III
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Nov 2005
- 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
- Signed consent.
- Male or female subjects > 18 yrs. old.
- RLS signs and symptoms affirming diagnosis.
- A baseline score > or = to 15 is required on the International RLS Study Group Rating Scale (IRLSSG).
- At least one leg with an average baseline Periodic Leg Movement (PLM) while asleep > or = to 15 movements per hour by actigraphy.
- Subjects on dopa-adrenergic therapy or other RLS treatments must be off therapy at least one week before any baseline RLS assessments and actigraphy measurement 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
- Known intolerance to Venofer.
- RLS which is ascribed to renal disease.
- RLS 2° to other CNS disease or injury.
- Any pain related or sleep related disorders which may confound the outcome measures.
- History of neuroleptic akinesia.
- Concurrent use of oral iron supplement.
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- Parenteral iron use within the past 6 months.
- Active infection.
- Currently being treated for asthma.
- Severe peripheral vascular disease with significant skin changes.
- Seizure disorder currently being treated with medication.
- Serum ferritin level > 300 ng/mL or a TSAT > or = to 45% at baseline or a history of hemochromatosis.
- Significant cardiovascular or hepatic disease or any other pre-existing medical condition or disease which in the view of the investigator participation in this study would put the subject's disease management at risk or the subject would be unable to comply with the study requirements.
About this study
Official title: Iron Sucrose In The Treatment of Restless Legs Syndrome (RLS): The Safety of Three Dose Regimens as Evaluated by Clinical Assessments
Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS were assigned to 1 of 3 treatment cohorts. The first cohort received one 500 mg IV iron sucrose infusion in 500 mL normal sterile saline (NSS) administered over four hours. The second cohort received two 500 mg IV iron sucrose infusions in 500mL of NSS administered over four to six hours on two separate dates, separated by two to seven days. The third cohort received two 500 mg IV iron sucrose infusions in at least 500 mL of NSS over six hours within 30 hours of the start of the first infusion. Cohorts were enrolled and treated subsequently.
- Conditions
- Restless Legs Syndrome
- Being tested
- Cohort I, Cohort II, Cohort III
- 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.
Cohort IDrug
Also called iron sucrose injection - Venofer
Cohort IIDrug
Also called iron sucrose injection - Venofer
Cohort IIIDrug
Also called iron sucrose injection - Venofer
| Study group | Role | What they receive |
|---|---|---|
| Cohort I | Experimental | 500 mg dose Venofer over 4 hours Receives: Drug: Cohort I |
| Cohort II | Experimental | 500 mg Venofer infusion over 4-6 hours on Day 0 and repeated on Day 2 to 7 Receives: Drug: Cohort II |
| Cohort III | Experimental | 500 mg Venofer over 6 hours, followed within 24 hours by 500 mg Venofer over 6 hours Receives: Drug: Cohort III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale
Validated rating scale of RLS symptoms (Range 1 [mild] - 40 [severe])
Measured: Baseline to Day 84
Secondary outcomes (1)
Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's)
Quantifies amount of leg movement
Measured: Baseline to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startNov 2003
- Primary completionAug 2005
- Study completionNov 2005
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 SyndromeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895232
- Sponsor's protocol ID
- 1VEN03032
- Status last verified
- Nov 2024
- First submitted
- 7 May 2009
- Last updated
- 7 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Sucrose In The Treatment of Restless Legs Syndrome (RLS): The Safety of Three Dose Regimens as Evaluated by Clinical Assessments
- ClinicalTrials.gov ID
- NCT00895232
- Acronym / sponsor ID
- 1VEN03032
- Conditions
- Restless Legs Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Aug 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 8 May 2009 (estimated)
- Results
- Posted 10 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS were assigned to 1 of 3 treatment cohorts. The first cohort received one 500 mg IV iron sucrose infusion in 500 mL normal sterile saline (NSS) administered over four hours. The second cohort received two 500 mg IV iron sucrose infusions in 500mL of NSS administered over four to six hours on two separate dates, separated by two to seven days. The third cohort received two 500 mg IV iron sucrose infusions in at least 500 mL of NSS over six hours within 30 hours of the start of the first infusion. Cohorts were enrolled and treated subsequently.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort I | Experimental | Drug: Cohort I500 mg dose Venofer over 4 hours |
| Cohort II | Experimental | Drug: Cohort II500 mg Venofer infusion over 4-6 hours on Day 0 and repeated on Day 2 to 7 |
| Cohort III | Experimental | Drug: Cohort III500 mg Venofer over 6 hours, followed within 24 hours by 500 mg Venofer over 6 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed consent.
- Male or female subjects > 18 yrs. old.
- RLS signs and symptoms affirming diagnosis.
- A baseline score > or = to 15 is required on the International RLS Study Group Rating Scale (IRLSSG).
- At least one leg with an average baseline Periodic Leg Movement (PLM) while asleep > or = to 15 movements per hour by actigraphy.
Key exclusion criteria (13 listed)
- Known intolerance to Venofer.
- RLS which is ascribed to renal disease.
- RLS 2° to other CNS disease or injury.
- Any pain related or sleep related disorders which may confound the outcome measures.
- History of neuroleptic akinesia.
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 |
|---|---|---|
| Cohort IAlso: iron sucrose injection - Venofer | Drug | Cohort I |
| Cohort IIAlso: iron sucrose injection - Venofer | Drug | Cohort II |
| Cohort IIIAlso: iron sucrose injection - Venofer | Drug | Cohort III |
Primary outcome
Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale
Time frame: Baseline to Day 84
Validated rating scale of RLS symptoms (Range 1 [mild] - 40 [severe])
1 secondary outcome
Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's)
Time frame: Baseline to Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- 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 Cohort I, Cohort II and Cohort III in people with Restless Legs Syndrome, 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 13 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 7 Nov 2024. 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. 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 10 Jun 2015). 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?
Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale (time frame: Baseline to Day 84). 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 7 Nov 2024.