Restless Legs SyndromePhase 2NCT02484768
IV Iron Treatment of Restless Legs Syndrome
A Phase 2 study testing Iron isomaltoside 1000 and Sodium Chloride 0.9% in people with Restless Legs Syndrome, run by Pharmacosmos A/S.
Trial summary
The purpose of this study is to to establish proof-of-concept for efficacy of iron isomaltoside 1000 in subjects with Restless Legs Syndrome. The study is a randomised, comparative, double-blind study with a 3 months extension. 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?
- Iron isomaltoside 1000 and Sodium Chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years
- Diagnosis of RLS based upon the CH-RLSq and HTDI
- IRLS score ≥ 15 at baseline evaluation when off RLS medications
- Willingness to participate and signing the informed consent form
Who cannot join
- S-ferritin > 300 ng/mL and/or TfS > 50 %
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemo-siderosis)
- Known hypersensitivity to IV iron or any excipients in the investigational drug prod-ucts
- Pregnant or nursing women. In order to avoid pregnancy, women of childbearing po-tential have to use adequate contraception (e.g. intrauterine devices, hormonal contra-ceptives, or double barrier method) during the whole study period and 7 days after the last dosing
- History of active asthma within the last 5 years
- Decompensated liver cirrhosis or active hepatitis (defined as ASAT or ALAT > 3 times upper limit of normal)
Show all 15Show fewer
- Active acute or chronic infections (assessed by clinical judgement supplied with WBC and CRP)
- Rheumatoid arthritis with symptoms or signs of active inflammation
- Pregnant or nursing women
- Previous IV iron treatment for RLS
- IV iron treatment within 1 year prior to screening
- Blood transfusion within 4 weeks prior to screening
- Planned elective surgery during the study
- Participation in any other interventional study where the study drug has not passed 5 half-lives prior to the screening
- Any other medical condition that, in the opinion of the Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. history of multiple allergies, a malignancy, uncon-trolled hypertension, unstable ischaemic heart disease, or uncontrolled diabetes melli-tus
About this study
Official title: A Phase II, Six-week, Randomised, Comparative, Double-blind Study of Intravenous Iron Isomaltoside 1000 Versus Placebo in Subjects With Restless Leg Syndrome With a 3 Month Extension
The purpose of this study is to to establish proof-of-concept for efficacy of iron isomaltoside 1000 in subjects with Restless Legs Syndrome.
The study is a randomised, comparative, double-blind study with a 3 months extension. Subjects with restless leg syndrome (RLS) will be randomised 2:1 to one of the following treat-ment groups:
- Group A (42 subjects): 1000 mg iron isomaltoside 1000
- Group B (21 subjects): Placebo infusion
Furthermore, non-responders, who continue to meet entry requirements, will receive 1000 mg iron isomaltoside 1000 at week 6.
Read the detailed description
RLS is a disorder of sensation with a prevalence of around 2-5 % of the population. RLS is extremely responsive to dopaminergic agents, but a second issue is that iron deficiency states may precipitate RLS in as much as 25-30 % of subjects with iron deficiency. RLS appears to be related to deficits in brain iron content and metabolism. Magnetic resonance imaging (MRI) images demonstrate a decrease in substantia nigra and red nucleus iron content. The severity of this decrease in brain iron content is correlated with the severity of symptoms. A number of patients are quite resistant to dietary iron repletion but do resolve symptoms with high doses of intravenous (IV) iron.
For the individual subject, there will be 4 phases to the study which includes teleconferences (TCs) and 2 visits.
The treatment and treatment evaluation is the main study.
- Conditions
- Restless Legs Syndrome
- Being tested
- Iron isomaltoside 1000, Sodium Chloride 0.9%
- 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.
Iron isomaltoside 1000Drug
Also called Monofer
Intravenous treatment
Sodium Chloride 0.9%Drug
Intravenous treatment
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Infusion of 1000 mg iron isomaltoside 1000 at baseline. The infusion is diluted in 100 mL 0.9 % sodium chloride and given over approximately 15 min Receives: Drug: Iron isomaltoside 1000 |
| Group B | Placebo comparator | Infusion of 100 mL 0.9 % sodium chloride at baseline given over approximately 15 min Receives: Drug: Sodium Chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the change in RLS symptoms from baseline to week 6 measured by the clinical global impression (CGI) score
Measured: 6 weeks
Secondary outcomes (4)
Change in RLS symptoms from baseline to week 4 and month 2 and 3 measured by the CGI score
Measured: 3 months
Change in RLS symptoms from baseline to week 4 and 6 and month 2 and 3 measured by the International Restless Legs Scale (IRLS)
Measured: from baseline to t = 12 weeks
Time from baseline to start of RLS medication
Measured: from baseline to t = 6 weeks
Time from baseline to start of RLS medication or non-response (CGI ≥ 3 at week 6)
Measured: from baseline to t = 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: as per GCP sponsor/company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioStata, Laboratory Corporation of America
- Responsible party
- Sponsor
- Investigators
- Richard Allen, Assoc Prof, Principal investigator, Johns Hopkins University Asthma& Allergy Bldg 1B76b 5501 Hopkins Bayview Blvd Baltimore, MD 21224 USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484768
- Sponsor's protocol ID
- P-RLS-01
- Status last verified
- Jun 2015
- First submitted
- 30 Mar 2015
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Six-week, Randomised, Comparative, Double-blind Study of Intravenous Iron Isomaltoside 1000 Versus Placebo in Subjects With Restless Leg Syndrome With a 3 Month Extension
- ClinicalTrials.gov ID
- NCT02484768
- Acronym / sponsor ID
- P-RLS-01
- Conditions
- Restless Legs Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: as per GCP sponsor/company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Collaborators
- BioStata, Laboratory Corporation of America
- Study start
- Jan 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
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 is to to establish proof-of-concept for efficacy of iron isomaltoside 1000 in subjects with Restless Legs Syndrome.
The study is a randomised, comparative, double-blind study with a 3 months extension. Subjects with restless leg syndrome (RLS) will be randomised 2:1 to one of the following treat-ment groups:
- Group A (42 subjects): 1000 mg iron isomaltoside 1000
- Group B (21 subjects): Placebo infusion
Furthermore, non-responders, who continue to meet entry requirements, will receive 1000 mg iron isomaltoside 1000 at week 6.
Detailed description
RLS is a disorder of sensation with a prevalence of around 2-5 % of the population. RLS is extremely responsive to dopaminergic agents, but a second issue is that iron deficiency states may precipitate RLS in as much as 25-30 % of subjects with iron deficiency. RLS appears to be related to deficits in brain iron content and metabolism. Magnetic resonance imaging (MRI) images demonstrate a decrease in substantia nigra and red nucleus iron content. The severity of this decrease in brain iron content is correlated with the severity of symptoms. A number of patients are quite resistant to dietary iron repletion but do resolve symptoms with high doses of intravenous (IV) iron.
For the individual subject, there will be 4 phases to the study which includes teleconferences (TCs) and 2 visits.
The treatment and treatment evaluation is the main study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Iron isomaltoside 1000Infusion of 1000 mg iron isomaltoside 1000 at baseline. The infusion is diluted in 100 mL 0.9 % sodium chloride and given over approximately 15 min |
| Group B | Placebo comparator | Drug: Sodium Chloride 0.9%Infusion of 100 mL 0.9 % sodium chloride at baseline given over approximately 15 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Diagnosis of RLS based upon the CH-RLSq and HTDI
- IRLS score ≥ 15 at baseline evaluation when off RLS medications
- Willingness to participate and signing the informed consent form
Key exclusion criteria (15 listed)
- S-ferritin > 300 ng/mL and/or TfS > 50 %
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemo-siderosis)
- Known hypersensitivity to IV iron or any excipients in the investigational drug prod-ucts
- Pregnant or nursing women. In order to avoid pregnancy, women of childbearing po-tential have to use adequate contraception (e.g. intrauterine devices, hormonal contra-ceptives, or double barrier method) during the whole study period and 7 days after the last dosing
- History of active asthma within the last 5 years
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 |
|---|---|---|
| Iron isomaltoside 1000Also: MonoferIntravenous treatment | Drug | Group A |
| Sodium Chloride 0.9%Intravenous treatment | Drug | Group B |
Primary outcome
To measure the change in RLS symptoms from baseline to week 6 measured by the clinical global impression (CGI) score
Time frame: 6 weeks
4 secondary outcomes
Change in RLS symptoms from baseline to week 4 and month 2 and 3 measured by the CGI score
Time frame: 3 months
Change in RLS symptoms from baseline to week 4 and 6 and month 2 and 3 measured by the International Restless Legs Scale (IRLS)
Time frame: from baseline to t = 12 weeks
Time from baseline to start of RLS medication
Time frame: from baseline to t = 6 weeks
Time from baseline to start of RLS medication or non-response (CGI ≥ 3 at week 6)
Time frame: from baseline to t = 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
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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.
Richard Allen, Assoc Prof principal investigator
Johns Hopkins University Asthma& Allergy Bldg 1B76b 5501 Hopkins Bayview Blvd Baltimore, MD 21224 USA
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iron isomaltoside 1000 and Sodium Chloride 0.9% in people with Restless Legs Syndrome, run by Pharmacosmos A/S.
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 15 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: withdrawn, as of the sponsor's last update on 30 Jun 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To measure the change in RLS symptoms from baseline to week 6 measured by the clinical global impression (CGI) score (time frame: 6 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 30 Jun 2015.