Multiple SclerosisNCT01973517
High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases
An observational study of Multiple Sclerosis, run by Stanford University at 2 sites in United States.
Trial summary
Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). In this project we hypothesize that Feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Feraheme and Gadolinium-based contrast
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Sep 2018
- Phase
- Observational
- 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
Study population: Population will be composed of patients with the diagnosis of relapsing remitting multiple sclerosis (MS) who are followed at the Stanford Neurosciences Clinic.
Who may be able to join
- Patients will be included if they are at least 18 years old and meet the revised diagnostic criteria for multiple sclerosis, relapsing remitting type.
- Patients will be included based on MR evidence of disease activity after Gadolinium (enhanced lesion) on a previous screening MR in the previous 3 weeks days before Feraheme administration.
Who cannot join
- Children (age < 18)
- Those who lack decision-making capability
- Contraindication to MRI such as pacemaker, other MR-incompatible metal implants or claustrophobia
- Known allergy to dextran or drugs containing iron salts or any previous history of severe allergic reactions
- Evidence of iron overload such as hemochromatosis or other hematologic disorders that imply iron level superior to the normal level.
- Pregnancy or breast feeding.
- History of renal disease or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) <40ml/min/1.73m?
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Richard M. Lucas Center for Imaging (of Stanford University)
Stanford, California, 94304
Stanford Hospitals and Clinics
Stanford, California, 94305
About this study
Official title: 7T MRI Ferumoxytol-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases
Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). In this project we hypothesize that Feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. We will explore this hypothesis taking advantage of ultra high field strength (7T) MRI to further increase the effectiveness of the contrast agent Feraheme at revealing inflammatory activity.
Read the detailed description
Multiple sclerosis (MS) is a neurological disorder that affects young adults world-wide. Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). After IV injection, the particles are taken up by the monocyte-macrophage system and can also be used to track macrophage infiltration by magnetic resonance imaging (MRI) after systemic injection owing to the strong image contrast of the iron-loaded macrophages. Approximately 24 hours after their IV injection, free particles are cleared from the circulation and MR signal alterations are thought to arise from the capture of particles by circulating phagocytic cells that are attracted to inflammatory lesions.
In this project we hypothesize that Feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. We will explore this hypothesis by taking advantage of ultra high field strength (7T) MRI to further increase the effectiveness of the contrast agent Feraheme at revealing inflammatory activity.
- Conditions
- Multiple Sclerosis
- Being tested
- Feraheme, Gadolinium-based contrast
- Keywords
- Multiple sclerosis, MRI, USPIO, Ferumoxytol, Feraheme
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerahemeDrug
Also called Ferumoxytol
Patients with relapsing remitting multiple sclerosis will be administered Feraheme 5mg/kg IV via slow push once and imaged under high-field MRI at least 24 hours following administration, to allow for adequate clearance of intravascular pharmaceutical.
Gadolinium-based contrastDrug
Also called Gadolinium
Patients with relapsing remitting multiple sclerosis will be administered gadolinium-based contrast at a dose of 0.1 mmol/kg IV once and imaged under high-field MRI immediately following administration.
| Study group | Role | What they receive |
|---|---|---|
| Relapsing Remitting MS | Patients with relapsing remitting multiple sclerosis will be imaged under high-field (7T) MRI prior to and following administration of gadolinium-based contrast (0.1 mmol/kg IV). Afterwards, they will be administered Feraheme 5mg/kg IV via slow push, and they will return 24 hours or later after pharmaceutical administration for post-Feraheme MR imaging. Receives: Drug: Feraheme; Drug: Gadolinium-based contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and location of enhancing brain lesions seen on 7 tesla MRI following Feraheme administration.
Magnetic resonance images of the brains of subjects will be evaluated independently by two expert readers blinded to the demographic and clinical data. The location and number of multiple sclerosis lesions that enhance following Feraheme administration will be recorded. These lesions will be compared with non-enhancing lesions and lesions that enhance with gadolinium-based contrast.
Measured: Baseline
Secondary outcomes (1)
Number and location of enhancing brain lesions seen on 7 tesla MRI following gadolinium-based contrast administration.
Magnetic resonance images of the brains of subjects will be evaluated independently by two expert readers blinded to the demographic and clinical data. The location and number of multiple sclerosis lesions that enhance following gadolinium-based contrast administration will be recorded. These lesions will be compared with non-enhancing lesions and lesions that enhance with Ferahame.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startApr 2014
- Primary completionSep 2018
- Study completionSep 2018
Why it stopped: Logistical factors affecting recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Zeineh, Stanford University
- Investigators
- Michael Zeineh, MD, PhD, Study director, Stanford UniversityBrian Rutt, PhD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973517
- Sponsor's protocol ID
- 27423-001
- Status last verified
- Sep 2018
- First submitted
- 16 Oct 2013
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Dousset V, Brochet B, Deloire MS, Lagoarde L, Barroso B, Caille JM, Petry KG. MR imaging of relapsing multiple sclerosis patients using ultra-small-particle iron oxide and compared with gadolinium. AJNR Am J Neuroradiol. 2006 May;27(5):1000-5.
PubMed 16687532Vellinga MM, Oude Engberink RD, Seewann A, Pouwels PJ, Wattjes MP, van der Pol SM, Pering C, Polman CH, de Vries HE, Geurts JJ, Barkhof F. Pluriformity of inflammation in multiple sclerosis shown by ultra-small iron oxide particle enhancement. Brain. 2008 Mar;131(Pt 3):800-7. doi: 10.1093/brain/awn009. Epub 2008 Feb 1.
PubMed 18245785Tourdias T, Roggerone S, Filippi M, Kanagaki M, Rovaris M, Miller DH, Petry KG, Brochet B, Pruvo JP, Radue EW, Dousset V. Assessment of disease activity in multiple sclerosis phenotypes with combined gadolinium- and superparamagnetic iron oxide-enhanced MR imaging. Radiology. 2012 Jul;264(1):225-33. doi: 10.1148/radiol.12111416.
PubMed 22723563Daldrup-Link HE, Rydland J, Helbich TH, Bjornerud A, Turetschek K, Kvistad KA, Kaindl E, Link TM, Staudacher K, Shames D, Brasch RC, Haraldseth O, Rummeny EJ. Quantification of breast tumor microvascular permeability with feruglose-enhanced MR imaging: initial phase II multicenter trial. Radiology. 2003 Dec;229(3):885-92. doi: 10.1148/radiol.2293021045. Epub 2003 Oct 23.
PubMed 14576446Metz S, Lohr S, Settles M, Beer A, Woertler K, Rummeny EJ, Daldrup-Link HE. Ferumoxtran-10-enhanced MR imaging of the bone marrow before and after conditioning therapy in patients with non-Hodgkin lymphomas. Eur Radiol. 2006 Mar;16(3):598-607. doi: 10.1007/s00330-005-0045-9. Epub 2005 Nov 12.
PubMed 16284770Pai AB, Nielsen JC, Kausz A, Miller P, Owen JS. Plasma pharmacokinetics of two consecutive doses of ferumoxytol in healthy subjects. Clin Pharmacol Ther. 2010 Aug;88(2):237-42. doi: 10.1038/clpt.2010.80. Epub 2010 Jun 30.
PubMed 20592725Provenzano R, Schiller B, Rao M, Coyne D, Brenner L, Pereira BJ. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009 Feb;4(2):386-93. doi: 10.2215/CJN.02840608. Epub 2009 Jan 28.
PubMed 19176796Schwenk MH. Ferumoxytol: a new intravenous iron preparation for the treatment of iron deficiency anemia in patients with chronic kidney disease. Pharmacotherapy. 2010 Jan;30(1):70-9. doi: 10.1592/phco.30.1.70.
PubMed 20030475Lu M, Cohen MH, Rieves D, Pazdur R. FDA report: Ferumoxytol for intravenous iron therapy in adult patients with chronic kidney disease. Am J Hematol. 2010 May;85(5):315-9. doi: 10.1002/ajh.21656.
PubMed 20201089Dousset V, Delalande C, Ballarino L, Quesson B, Seilhan D, Coussemacq M, Thiaudiere E, Brochet B, Canioni P, Caille JM. In vivo macrophage activity imaging in the central nervous system detected by magnetic resonance. Magn Reson Med. 1999 Feb;41(2):329-33. doi: 10.1002/(sici)1522-2594(199902)41:23.0.co;2-z.
PubMed 10080281Dousset V, Ballarino L, Delalande C, Coussemacq M, Canioni P, Petry KG, Caille JM. Comparison of ultrasmall particles of iron oxide (USPIO)-enhanced T2-weighted, conventional T2-weighted, and gadolinium-enhanced T1-weighted MR images in rats with experimental autoimmune encephalomyelitis. AJNR Am J Neuroradiol. 1999 Feb;20(2):223-7.
PubMed 10094342Floris S, Blezer EL, Schreibelt G, Dopp E, van der Pol SM, Schadee-Eestermans IL, Nicolay K, Dijkstra CD, de Vries HE. Blood-brain barrier permeability and monocyte infiltration in experimental allergic encephalomyelitis: a quantitative MRI study. Brain. 2004 Mar;127(Pt 3):616-27. doi: 10.1093/brain/awh068. Epub 2003 Dec 22.
PubMed 14691063Ladewig G, Jestaedt L, Misselwitz B, Solymosi L, Toyka K, Bendszus M, Stoll G. Spatial diversity of blood-brain barrier alteration and macrophage invasion in experimental autoimmune encephalomyelitis: a comparative MRI study. Exp Neurol. 2009 Nov;220(1):207-11. doi: 10.1016/j.expneurol.2009.08.027. Epub 2009 Sep 4.
PubMed 19733560Chin CL, Pai M, Bousquet PF, Schwartz AJ, O'Connor EM, Nelson CM, Hradil VP, Cox BF, McRae BL, Fox GB. Distinct spatiotemporal pattern of CNS lesions revealed by USPIO-enhanced MRI in MOG-induced EAE rats implicates the involvement of spino-olivocerebellar pathways. J Neuroimmunol. 2009 Jun 25;211(1-2):49-55. doi: 10.1016/j.jneuroim.2009.03.012. Epub 2009 Apr 5.
PubMed 19346009Petry KG, Boiziau C, Dousset V, Brochet B. Magnetic resonance imaging of human brain macrophage infiltration. Neurotherapeutics. 2007 Jul;4(3):434-42. doi: 10.1016/j.nurt.2007.05.005.
PubMed 17599709
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7T MRI Ferumoxytol-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases
- ClinicalTrials.gov ID
- NCT01973517
- Acronym / sponsor ID
- 27423-001
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, MRI, USPIO, Ferumoxytol, Feraheme
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Logistical factors affecting recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 31 Oct 2013 (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.
Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). In this project we hypothesize that Feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. We will explore this hypothesis taking advantage of ultra high field strength (7T) MRI to further increase the effectiveness of the contrast agent Feraheme at revealing inflammatory activity.
Detailed description
Multiple sclerosis (MS) is a neurological disorder that affects young adults world-wide. Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). After IV injection, the particles are taken up by the monocyte-macrophage system and can also be used to track macrophage infiltration by magnetic resonance imaging (MRI) after systemic injection owing to the strong image contrast of the iron-loaded macrophages. Approximately 24 hours after their IV injection, free particles are cleared from the circulation and MR signal alterations are thought to arise from the capture of particles by circulating phagocytic cells that are attracted to inflammatory lesions.
In this project we hypothesize that Feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. We will explore this hypothesis by taking advantage of ultra high field strength (7T) MRI to further increase the effectiveness of the contrast agent Feraheme at revealing inflammatory activity.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsing Remitting MS | – | Drug: Feraheme, Drug: Gadolinium-based contrastPatients with relapsing remitting multiple sclerosis will be imaged under high-field (7T) MRI prior to and following administration of gadolinium-based contrast (0.1 mmol/kg IV). Afterwards, they will be administered Feraheme 5mg/kg IV via slow push, and they will return 24 hours or later after pharmaceutical administration for post-Feraheme MR imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population will be composed of patients with the diagnosis of relapsing remitting multiple sclerosis (MS) who are followed at the Stanford Neurosciences Clinic.
Key inclusion criteria (2 listed)
- Patients will be included if they are at least 18 years old and meet the revised diagnostic criteria for multiple sclerosis, relapsing remitting type.
- Patients will be included based on MR evidence of disease activity after Gadolinium (enhanced lesion) on a previous screening MR in the previous 3 weeks days before Feraheme administration.
Key exclusion criteria (7 listed)
- Children (age < 18)
- Those who lack decision-making capability
- Contraindication to MRI such as pacemaker, other MR-incompatible metal implants or claustrophobia
- Known allergy to dextran or drugs containing iron salts or any previous history of severe allergic reactions
- Evidence of iron overload such as hemochromatosis or other hematologic disorders that imply iron level superior to the normal level.
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 |
|---|---|---|
| FerahemeAlso: FerumoxytolPatients with relapsing remitting multiple sclerosis will be administered Feraheme 5mg/kg IV via slow push once and imaged under high-field MRI at least 24 hours following administration, to allow for adequate clearance of intravascular pharmaceutical. | Drug | Relapsing Remitting MS |
| Gadolinium-based contrastAlso: GadoliniumPatients with relapsing remitting multiple sclerosis will be administered gadolinium-based contrast at a dose of 0.1 mmol/kg IV once and imaged under high-field MRI immediately following administration. | Drug | Relapsing Remitting MS |
Primary outcome
Number and location of enhancing brain lesions seen on 7 tesla MRI following Feraheme administration.
Time frame: Baseline
Magnetic resonance images of the brains of subjects will be evaluated independently by two expert readers blinded to the demographic and clinical data. The location and number of multiple sclerosis lesions that enhance following Feraheme administration will be recorded. These lesions will be compared with non-enhancing lesions and lesions that enhance with gadolinium-based contrast.
1 secondary outcome
Number and location of enhancing brain lesions seen on 7 tesla MRI following gadolinium-based contrast administration.
Time frame: Baseline
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 10 Sep 2018.
- Background: PubMed 16687532Dousset V, Brochet B, Deloire MS, Lagoarde L, Barroso B, Caille JM, Petry KG. MR imaging of relapsing multiple sclerosis patients using ultra-small-particle iron oxide and compared with gadolinium. AJNR Am J Neuroradiol. 2006 May;27(5):1000-5.
- Background: PubMed 18245785Vellinga MM, Oude Engberink RD, Seewann A, Pouwels PJ, Wattjes MP, van der Pol SM, Pering C, Polman CH, de Vries HE, Geurts JJ, Barkhof F. Pluriformity of inflammation in multiple sclerosis shown by ultra-small iron oxide particle enhancement. Brain. 2008 Mar;131(Pt 3):800-7. doi: 10.1093/brain/awn009. Epub 2008 Feb 1.
- Background: PubMed 22723563Tourdias T, Roggerone S, Filippi M, Kanagaki M, Rovaris M, Miller DH, Petry KG, Brochet B, Pruvo JP, Radue EW, Dousset V. Assessment of disease activity in multiple sclerosis phenotypes with combined gadolinium- and superparamagnetic iron oxide-enhanced MR imaging. Radiology. 2012 Jul;264(1):225-33. doi: 10.1148/radiol.12111416.
- Background: PubMed 14576446Daldrup-Link HE, Rydland J, Helbich TH, Bjornerud A, Turetschek K, Kvistad KA, Kaindl E, Link TM, Staudacher K, Shames D, Brasch RC, Haraldseth O, Rummeny EJ. Quantification of breast tumor microvascular permeability with feruglose-enhanced MR imaging: initial phase II multicenter trial. Radiology. 2003 Dec;229(3):885-92. doi: 10.1148/radiol.2293021045. Epub 2003 Oct 23.
- Background: PubMed 16284770Metz S, Lohr S, Settles M, Beer A, Woertler K, Rummeny EJ, Daldrup-Link HE. Ferumoxtran-10-enhanced MR imaging of the bone marrow before and after conditioning therapy in patients with non-Hodgkin lymphomas. Eur Radiol. 2006 Mar;16(3):598-607. doi: 10.1007/s00330-005-0045-9. Epub 2005 Nov 12.
- Background: PubMed 20592725Pai AB, Nielsen JC, Kausz A, Miller P, Owen JS. Plasma pharmacokinetics of two consecutive doses of ferumoxytol in healthy subjects. Clin Pharmacol Ther. 2010 Aug;88(2):237-42. doi: 10.1038/clpt.2010.80. Epub 2010 Jun 30.
- Background: PubMed 19176796Provenzano R, Schiller B, Rao M, Coyne D, Brenner L, Pereira BJ. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009 Feb;4(2):386-93. doi: 10.2215/CJN.02840608. Epub 2009 Jan 28.
- Background: PubMed 20030475Schwenk MH. Ferumoxytol: a new intravenous iron preparation for the treatment of iron deficiency anemia in patients with chronic kidney disease. Pharmacotherapy. 2010 Jan;30(1):70-9. doi: 10.1592/phco.30.1.70.
- Background: PubMed 20201089Lu M, Cohen MH, Rieves D, Pazdur R. FDA report: Ferumoxytol for intravenous iron therapy in adult patients with chronic kidney disease. Am J Hematol. 2010 May;85(5):315-9. doi: 10.1002/ajh.21656.
- Background: PubMed 10080281Dousset V, Delalande C, Ballarino L, Quesson B, Seilhan D, Coussemacq M, Thiaudiere E, Brochet B, Canioni P, Caille JM. In vivo macrophage activity imaging in the central nervous system detected by magnetic resonance. Magn Reson Med. 1999 Feb;41(2):329-33. doi: 10.1002/(sici)1522-2594(199902)41:23.0.co;2-z.
- Background: PubMed 10094342Dousset V, Ballarino L, Delalande C, Coussemacq M, Canioni P, Petry KG, Caille JM. Comparison of ultrasmall particles of iron oxide (USPIO)-enhanced T2-weighted, conventional T2-weighted, and gadolinium-enhanced T1-weighted MR images in rats with experimental autoimmune encephalomyelitis. AJNR Am J Neuroradiol. 1999 Feb;20(2):223-7.
- Background: PubMed 14691063Floris S, Blezer EL, Schreibelt G, Dopp E, van der Pol SM, Schadee-Eestermans IL, Nicolay K, Dijkstra CD, de Vries HE. Blood-brain barrier permeability and monocyte infiltration in experimental allergic encephalomyelitis: a quantitative MRI study. Brain. 2004 Mar;127(Pt 3):616-27. doi: 10.1093/brain/awh068. Epub 2003 Dec 22.
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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.
Michael Zeineh, MD, PhD study director
Stanford University
Brian Rutt, PhD study director
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Stanford University at 2 sites 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 2 inclusion and 7 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 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Number and location of enhancing brain lesions seen on 7 tesla MRI following Feraheme administration. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01973517, which also lists 15 linked publications.
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 10 Sep 2018.