Disturbance of ConsciousnessMETA-GCANCT06911515
Evaluation of Essential Metal Metabolism
An observational study of Disturbance of Consciousness and Alteration of Metabolism, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Disturbance of consciousness (DoC) is a state in which consciousness is altered following brain damage and can manifest in several conditions that result from the loss of regulation of the neural function of the two components of consciousness, alertness and awareness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disturbance of Consciousness, Alteration of Metabolism, Essential Metals
- What is being tested?
- peripheral venous blood samples, these will be performed in order to measure the biological markers in the serum
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 17 Mar 2025to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients of both sexes with DoC being treated at the U.O.C. of High Intensity Neurorehabilitation, Fondazione Policlinico Universitario Gemelli IRCCS of Rome
Who may be able to join
- Patients who have been in a coma state, documented with a GCS ≤ 8 for at least 24 hours;
- Presence of a disturbance of consciousness, identified through the Coma Recovery Scale-revised (CRS-r) and classified as coma, vegetative state or minimally conscious state;
- Latency of the acute event between 15 days and 6 months;
- Ability of the caregiver/guardian to understand and sign the informed consent.
Who cannot join
- Age <18 years;
- Psychiatric or other pathologies;
- Inflammatory state related to ongoing infections;
- Refusal or inability to sign the written informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Italy1 site
UOC Neuroriabilitazione ad alta intensità , Policlinico "A. Gemelli"
Roma, RM, 00168
About this study
Official title: Evaluation of Essential Metal Metabolism in Patients With Disorders of Consciousness
Disturbance of consciousness (DoC) is a state in which consciousness is altered following brain damage and can manifest in several conditions that result from the loss of regulation of the neural function of the two components of consciousness, alertness and awareness.
It is known that the main causes of disorders of consciousness have important effects on the disruption of essential metal homeostasis.
Read more
In particular, myocardial infarction and heart failure, ischemic and hemorrhagic stroke and head trauma trigger phenomena of diffuse axonal damage, hypoxia and re-perfusion that profoundly alter the metabolism of cerebral O2 that reacts with essential metals , in Fenton-type reactions whose predominant effect is an extensive production of reactive oxygen species (ROS) and pro-oxidant molecules.
Fe, Cu and zinc (Zn) are essential metals for life: two thirds of the proteins in our body use these metals that play a crucial role as catalysts or structural elements of proteins in various biological processes, such as cellular respiration in mitochondria, the production and maturation of red and white blood cells, the elasticity of connective tissue, the production of myelin and the production of some neurotransmitters. For this reason, the biology of essential metals has a major impact on our health and the disruption of their homeostasis inexorably leads to disease.
These metals are very important for the metabolism of the Central Nervous System (CNS) and Cu, in particular, even in adults, is involved in the production of myelin and in the production of some neurotransmitters of the diffuse modulatory systems . Cu is a cofactor of the enzymes dopamine β-hydroxylase, and monoamine oxidase involved in the balance of catecholamines , and is altered in some disorders of Cu metabolism.
- Being tested
- peripheral venous blood samples, these will be performed in order to measure the biological markers in the serum
- Keywords
- patients with disturbance of consciousness, essential metal, metabolism status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral venous blood samples, these will be performed in order to measure the biological markers in the serumOther
peripheral venous blood samples, these will be performed in order to measure the biological markers in the serum
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Gruop A | Difference in metal concentrations (7 metals) in GCA subjects compared to those in previously acquired sera of healthy controls. Receives: Other: peripheral venous blood samples, these will be performed in order to measure the biological markers in the serum | |
| Experimental: Group B: Differences and Correlation | Differences in essential metal concentrations at 30 days compared to baseline in GCA patients.
* Baseline differences in essential metal metabolism in subcategories of patients with impaired consciousness (coma/VS vs MCS, traumatic brain injury vs non-traumatic brain injury).
* Correlation between clinical scales and essential metal metabolism Receives: Other: peripheral venous blood samples, these will be performed in order to measure the biological markers in the serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concetration of essential metal in patients with acquired brain injury
Quantification of blood essential metal levels in peripheral venous blood samples in patients with acquired brain injury (Fe, range: Men: 65-178 µg/dL, Women: 50-170 µg/dL; Zn, range: 75- 110 µg/dL; Cu, range: Men: 60-160 µg/dL, Women: 80-155 µg/dL;non-Cp Cu, range: less than 5 µg/dL) compared to healthy patients.
Measured: Changes from baseline (T0), after 30 days of treatment (T1)
Secondary outcomes (5)
Differences in essential metal blood concentration in subcategories of patients with impaired consciousness
Baseline differences in essential metal metabolism in subcategories of patients with disturbance of consciousness (coma/VS vs MCS using CRS-r scale range: 0 to 23).
Measured: At baseline (T0) and 30 days (T1)
Differences in essential metal blood concentration in subcategories of patients with acquired brain injury (traumatic vs non-traumatic)
Baseline differences in essential metal blood concentration in subcategories of patients with acquired brain injury ( etiology: traumatic vs non-traumatic).
Measured: At baseline (T0) and 30 days (T1)
Correlation between clinical outcome related to autonomy and disability and essential metal blood concentration
The clinical evaluation will be carried out using the following evaluation scales: Barthel Index (mBI) (range 0 to 100), the Disability Rating Scale (DRS) (range 0 to 29). As regards peripheral venous blood sampling, these will be performed in order to measure the following biological markers on serum: Fe, range men 65 and 178 µg/dL, women 50 and 170 µg/dL; Zn, range 75 -110 µg/dL; Cu, range men 60-160 µg/dL, women: 80-155 µg/dL; Ferr, range men 20-200 ng/mL, women 20-120 ng/mL; Tf, range men: 215-365 mg/dL, women: 250-380 mg/dL; Cp, range 20-50 mg/dL: Non-Cp Cu, range less than 5 µg/dL.
Measured: At baseline (T0) and 30 days (T1)
Correlation between clinical outcome related to motor performance and essential metal blood concentration
The clinical evaluation will be carried out using the following evaluation scales: Motricity Index (range 0 to 100 points). As regards peripheral venous blood sampling, these will be performed in order to measure the following biological markers on serum: Fe, range men 65 and 178 µg/dL, women 50 and 170 µg/dL; Zn, range 75 -110 µg/dL; Cu, range men 60-160 µg/dL, women: 80-155 µg/dL; Ferr, range men 20-200 ng/mL, women 20-120 ng/mL; Tf, range men: 215-365 mg/dL, women: 250-380 mg/dL; Cp, range 20-50 mg/dL: Non-Cp Cu, range less than 5 µg/dL.
Measured: At baseline (T0) and 30 days (T1)
Correlation between clinical outcome related to state of consciousness and cognitive level and essential metal blood concentration
The clinical evaluation will be carried out using the following evaluation scales: Coma Recovery Scale - Journal (CRS-r) (range 0 to 23), the Level of Cognitive Functioning (LCF) (range10 levels) and the Full Outline of UnResponsiveness (FOUR-Score) (range 0 to 16). As regards peripheral venous blood sampling, these will be performed in order to measure the following biological markers on serum: Fe, range men 65 and 178 µg/dL, women 50 and 170 µg/dL; Zn, range 75 -110 µg/dL; Cu, range men 60-160 µg/dL, women: 80-155 µg/dL; Ferr, range men 20-200 ng/mL, women 20-120 ng/mL; Tf, range men: 215-365 mg/dL, women: 250-380 mg/dL; Cp, range 20-50 mg/dL: Non-Cp Cu, range less than 5 µg/dL.
Measured: At baseline (T0) and 30 days (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start17 Mar 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Disturbance of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Other
- Time perspective
- Other
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PADUA LUCA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Stefano mr Bonomi, MD,, Study chair, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911515
- Sponsor's protocol ID
- 6279
- Acronym
- META-GCA
- Status last verified
- Apr 2025
- First submitted
- 17 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grassi M, Palluzzi F, Tarantino B. SEMgraph: an R package for causal network inference of high-throughput data with structural equation models. Bioinformatics. 2022 Oct 14;38(20):4829-4830. doi: 10.1093/bioinformatics/btac567.
PubMed 36040154Nicoletti VG, Pajer K, Calcagno D, Pajenda G, Nogradi A. The Role of Metals in the Neuroregenerative Action of BDNF, GDNF, NGF and Other Neurotrophic Factors. Biomolecules. 2022 Jul 22;12(8):1015. doi: 10.3390/biom12081015.
PubMed 35892326Giacino JT, Kalmar K. Diagnostic and prognostic guidelines for the vegetative and minimally conscious states. Neuropsychol Rehabil. 2005 Jul-Sep;15(3-4):166-74. doi: 10.1080/09602010443000498.
PubMed 16350959Squitti R, Ventriglia M, Simonelli I, Bonvicini C, Costa A, Perini G, Binetti G, Benussi L, Ghidoni R, Koch G, Borroni B, Albanese A, Sensi SL, Rongioletti M. Copper Imbalance in Alzheimer's Disease: Meta-Analysis of Serum, Plasma, and Brain Specimens, and Replication Study Evaluating ATP7B Gene Variants. Biomolecules. 2021 Jun 29;11(7):960. doi: 10.3390/biom11070960.
PubMed 34209820Squitti R, Faller P, Hureau C, Granzotto A, White AR, Kepp KP. Copper Imbalance in Alzheimer's Disease and Its Link with the Amyloid Hypothesis: Towards a Combined Clinical, Chemical, and Genetic Etiology. J Alzheimers Dis. 2021;83(1):23-41. doi: 10.3233/JAD-201556.
PubMed 34219710Cheng L, Cortese D, Monti MM, Wang F, Riganello F, Arcuri F, Di H, Schnakers C. Do Sensory Stimulation Programs Have an Impact on Consciousness Recovery? Front Neurol. 2018 Oct 2;9:826. doi: 10.3389/fneur.2018.00826. eCollection 2018.
PubMed 30333789Squitti R, Reale G, Tondolo V, Crescenti D, Bellini S, Moci M, Caliandro P, Padua L, Rongioletti M. Imbalance of Essential Metals in Traumatic Brain Injury and Its Possible Link with Disorders of Consciousness. Int J Mol Sci. 2023 Apr 6;24(7):6867. doi: 10.3390/ijms24076867.
PubMed 37047843Dolce G, Lucca LF, Riganello F, Arcuri F, Quintieri M, Cortese MD, Pignolo L. Advances in the neurorehabilitation of severe disorder of consciousness. Ann Ist Super Sanita. 2014;50(3):234-40. doi: 10.4415/ANN_14_03_06.
PubMed 25292271von Wild K, Laureys ST, Gerstenbrand F, Dolce G, Onose G. The vegetative state--a syndrome in search of a name. J Med Life. 2012 Feb 22;5(1):3-15. Epub 2012 Mar 5.
PubMed 22574081Laureys S, Celesia GG, Cohadon F, Lavrijsen J, Leon-Carrion J, Sannita WG, Sazbon L, Schmutzhard E, von Wild KR, Zeman A, Dolce G; European Task Force on Disorders of Consciousness. Unresponsive wakefulness syndrome: a new name for the vegetative state or apallic syndrome. BMC Med. 2010 Nov 1;8:68. doi: 10.1186/1741-7015-8-68.
PubMed 21040571Davis T, Ings A; National Institute of Health and Care Excellence. Head injury: triage, assessment, investigation and early management of head injury in children, young people and adults (NICE guideline CG 176). Arch Dis Child Educ Pract Ed. 2015 Apr;100(2):97-100. doi: 10.1136/archdischild-2014-306797. Epub 2014 Oct 21. No abstract available.
PubMed 25335757
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Essential Metal Metabolism in Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT06911515
- Acronym / sponsor ID
- META-GCA / 6279
- Keywords
- patients with disturbance of consciousness, essential metal, metabolism status
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 4 Apr 2025 (actual)
- 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.
Disturbance of consciousness (DoC) is a state in which consciousness is altered following brain damage and can manifest in several conditions that result from the loss of regulation of the neural function of the two components of consciousness, alertness and awareness.
It is known that the main causes of disorders of consciousness have important effects on the disruption of essential metal homeostasis.
In particular, myocardial infarction and heart failure, ischemic and hemorrhagic stroke and head trauma trigger phenomena of diffuse axonal damage, hypoxia and re-perfusion that profoundly alter the metabolism of cerebral O2 that reacts with essential metals , in Fenton-type reactions whose predominant effect is an extensive production of reactive oxygen species (ROS) and pro-oxidant molecules.
Fe, Cu and zinc (Zn) are essential metals for life: two thirds of the proteins in our body use these metals that play a crucial role as catalysts or structural elements of proteins in various biological processes, such as cellular respiration in mitochondria, the production and maturation of red and white blood cells, the elasticity of connective tissue, the production of myelin and the production of some neurotransmitters. For this reason, the biology of essential metals has a major impact on our health and the disruption of their homeostasis inexorably leads to disease.
These metals are very important for the metabolism of the Central Nervous System (CNS) and Cu, in particular, even in adults, is involved in the production of myelin and in the production of some neurotransmitters of the diffuse modulatory systems . Cu is a cofactor of the enzymes dopamine β-hydroxylase, and monoamine oxidase involved in the balance of catecholamines , and is altered in some disorders of Cu metabolism.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Gruop A | – | Other: peripheral venous blood samples, these will be performed in order to measure the biological markers in the serumDifference in metal concentrations (7 metals) in GCA subjects compared to those in previously acquired sera of healthy controls. |
| Experimental: Group B: Differences and Correlation | – | Other: peripheral venous blood samples, these will be performed in order to measure the biological markers in the serumDifferences in essential metal concentrations at 30 days compared to baseline in GCA patients. * Baseline differences in essential metal metabolism in subcategories of patients with impaired consciousness (coma/VS vs MCS, traumatic brain injury vs non-traumatic brain injury). * Correlation between clinical scales and essential metal metabolism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both sexes with DoC being treated at the U.O.C. of High Intensity Neurorehabilitation, Fondazione Policlinico Universitario Gemelli IRCCS of Rome
Key inclusion criteria (4 listed)
- Patients who have been in a coma state, documented with a GCS ≤ 8 for at least 24 hours;
Key exclusion criteria (4 listed)
- Age <18 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 |
|---|---|---|
| peripheral venous blood samples, these will be performed in order to measure the biological markers in the serumperipheral venous blood samples, these will be performed in order to measure the biological markers in the serum | Other | Experimental: Group B: Differences and Correlation, Experimental: Gruop A |
Primary outcome
Blood concetration of essential metal in patients with acquired brain injury
Time frame: Changes from baseline (T0), after 30 days of treatment (T1)
Quantification of blood essential metal levels in peripheral venous blood samples in patients with acquired brain injury (Fe, range: Men: 65-178 µg/dL, Women: 50-170 µg/dL; Zn, range: 75- 110 µg/dL; Cu, range: Men: 60-160 µg/dL, Women: 80-155 µg/dL;non-Cp Cu, range: less than 5 µg/dL) compared to healthy patients.
5 secondary outcomes
Differences in essential metal blood concentration in subcategories of patients with impaired consciousness
Time frame: At baseline (T0) and 30 days (T1)
Differences in essential metal blood concentration in subcategories of patients with acquired brain injury (traumatic vs non-traumatic)
Time frame: At baseline (T0) and 30 days (T1)
Correlation between clinical outcome related to autonomy and disability and essential metal blood concentration
Time frame: At baseline (T0) and 30 days (T1)
Correlation between clinical outcome related to motor performance and essential metal blood concentration
Time frame: At baseline (T0) and 30 days (T1)
Correlation between clinical outcome related to state of consciousness and cognitive level and essential metal blood concentration
Time frame: At baseline (T0) and 30 days (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 36040154Grassi M, Palluzzi F, Tarantino B. SEMgraph: an R package for causal network inference of high-throughput data with structural equation models. Bioinformatics. 2022 Oct 14;38(20):4829-4830. doi: 10.1093/bioinformatics/btac567.
- Background: PubMed 35892326Nicoletti VG, Pajer K, Calcagno D, Pajenda G, Nogradi A. The Role of Metals in the Neuroregenerative Action of BDNF, GDNF, NGF and Other Neurotrophic Factors. Biomolecules. 2022 Jul 22;12(8):1015. doi: 10.3390/biom12081015.
- Background: PubMed 16350959Giacino JT, Kalmar K. Diagnostic and prognostic guidelines for the vegetative and minimally conscious states. Neuropsychol Rehabil. 2005 Jul-Sep;15(3-4):166-74. doi: 10.1080/09602010443000498.
- Background: PubMed 34209820Squitti R, Ventriglia M, Simonelli I, Bonvicini C, Costa A, Perini G, Binetti G, Benussi L, Ghidoni R, Koch G, Borroni B, Albanese A, Sensi SL, Rongioletti M. Copper Imbalance in Alzheimer's Disease: Meta-Analysis of Serum, Plasma, and Brain Specimens, and Replication Study Evaluating ATP7B Gene Variants. Biomolecules. 2021 Jun 29;11(7):960. doi: 10.3390/biom11070960.
- Background: PubMed 34219710Squitti R, Faller P, Hureau C, Granzotto A, White AR, Kepp KP. Copper Imbalance in Alzheimer's Disease and Its Link with the Amyloid Hypothesis: Towards a Combined Clinical, Chemical, and Genetic Etiology. J Alzheimers Dis. 2021;83(1):23-41. doi: 10.3233/JAD-201556.
- Background: PubMed 30333789Cheng L, Cortese D, Monti MM, Wang F, Riganello F, Arcuri F, Di H, Schnakers C. Do Sensory Stimulation Programs Have an Impact on Consciousness Recovery? Front Neurol. 2018 Oct 2;9:826. doi: 10.3389/fneur.2018.00826. eCollection 2018.
- Background: PubMed 37047843Squitti R, Reale G, Tondolo V, Crescenti D, Bellini S, Moci M, Caliandro P, Padua L, Rongioletti M. Imbalance of Essential Metals in Traumatic Brain Injury and Its Possible Link with Disorders of Consciousness. Int J Mol Sci. 2023 Apr 6;24(7):6867. doi: 10.3390/ijms24076867.
- Background: PubMed 25292271Dolce G, Lucca LF, Riganello F, Arcuri F, Quintieri M, Cortese MD, Pignolo L. Advances in the neurorehabilitation of severe disorder of consciousness. Ann Ist Super Sanita. 2014;50(3):234-40. doi: 10.4415/ANN_14_03_06.
- Background: PubMed 22574081von Wild K, Laureys ST, Gerstenbrand F, Dolce G, Onose G. The vegetative state--a syndrome in search of a name. J Med Life. 2012 Feb 22;5(1):3-15. Epub 2012 Mar 5.
- Background: PubMed 21040571Laureys S, Celesia GG, Cohadon F, Lavrijsen J, Leon-Carrion J, Sannita WG, Sazbon L, Schmutzhard E, von Wild KR, Zeman A, Dolce G; European Task Force on Disorders of Consciousness. Unresponsive wakefulness syndrome: a new name for the vegetative state or apallic syndrome. BMC Med. 2010 Nov 1;8:68. doi: 10.1186/1741-7015-8-68.
- Background: PubMed 25335757Davis T, Ings A; National Institute of Health and Care Excellence. Head injury: triage, assessment, investigation and early management of head injury in children, young people and adults (NICE guideline CG 176). Arch Dis Child Educ Pract Ed. 2015 Apr;100(2):97-100. doi: 10.1136/archdischild-2014-306797. Epub 2014 Oct 21. No abstract available.
- Individual participant dataSharing planned: No
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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.
Stefano mr Bonomi, MD, study chair
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disturbance of Consciousness and Alteration of Metabolism, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 9 Apr 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Blood concetration of essential metal in patients with acquired brain injury (time frame: Changes from baseline (T0), after 30 days of treatment (T1)). 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 NCT06911515, which also lists 11 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 9 Apr 2025.