ComaPRECOMNCT05321459
Predictive Outcome in Comatose Patients
An observational study of Coma and Heart Arrest, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
Trial summary
Evaluating the prognosis of comatose patients after cardiac arrest (CA) in the intensive care unit (ICU) remains challenging. It requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations, (among them auditive evoked… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coma, Heart Arrest, Cardiopulmonary Resuscitation
- What is being tested?
- Neurological prognosis
- How many people
- 100 participants
- Where
- 7 sitesFrance
- Study dates
- 15 Nov 2023to 29 May 2028
- 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
- Adult, Older adult
Study population: Adult patients admitted to intensive care following a cardica arrest.
Who may be able to join
- Age above18 years old
- Patient affiliated to a French Heath Care Insurance
- Admitted in the intensive care unit (ICU) for coma post extra- or intra-hospital cardiac arrest (CA) with shockable or non-shockable rhythm
- Persistent coma on day 3 after post CA, defined by the inability to respond to a verbal command in an appropriate manner (motor Glasgow components ≤ 3) and at the time of neurophysiological recordings (D3-D7 ± week -end).
Who cannot join
- Decision to limit resuscitation therapies taken by the resuscitation team
- Inability to perform the auditory evoked potentials (AEP) (deafness, skin lesion or any condition preventing to record AEP).
- Opposition by the trusted person or by the patient once he/she wakes up
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 6 recruiting
- Recruiting
APHP Avicenne Hospital - Réanimation médico-chirurgicale
Bobigny, 93000
Johanna OZIEL, Ph, +33 1 48 95 52 41, johanna.oziel@aphp.fr
Johanna OZIEL, Ph
- Active, not recruiting
APHP Lariboisière Hospital, Clinical Physiology Department
Paris, 75010
- Recruiting
APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique
Paris, 75010
Bruno MEGARBANE, MD, PhD, +33 (0)1 49 95 64 91, bruno.megarbane@aphp.fr
Bruno MEGARBANE, Md, PhD
- Recruiting
APHP Cochin Hospital - médecine intensive-réanimation
Paris, 75014
Sarah BENGHANEM, Ph, +33 1 58 41 25 33, sarah.benghanem@aphp.fr
Sarah BENGHANEM, Ph
- Recruiting
APHP HEGP hospital - Réanimation médicale
Paris, 75015
Jean-Luc DIEHL, Md,PhD, jean-luc.diehl@aphp.fr
Jean-Luc DIEHL, Md,PhD
- Recruiting
APHP Bichat Hospital -Médecine intensive - réanimation infectieuse
Paris, 75018
Marc DOMAN, Ph, +33 1 40 25 79 24, marc.doman@aphp.fr
Marc DOMAN, Ph
- Recruiting
Delafontaine Hospital - médecine intensive-réanimation
Saint-Denis, 93200
Daniel DA SILVA, Md, daniel.silva@ch-stdenis.mssante.fr
Daniel DA SILVA, Md
About this study
Official title: New Predictive Tool of Awakening in Comatose Patients in the Intensive Care Unit
Evaluating the prognosis of comatose patients after cardiac arrest (CA) in the intensive care unit (ICU) remains challenging. It requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations, (among them auditive evoked potentials or AEP) but none has a sufficient sensitivity/specificity. In a preliminary study, the investigators developed an algorithm from the signal collected with AEP, and generated a probability map to visually classify the participants after the algorithm processing. Participants could be classified either with a good neurological prognosis or with bad neurological prognosis or death.
The investigators hypothesize that the "PRECOM" tool, applied blindly to a large prospective multicenter cohort of patients admitted to intensive care for coma in the aftermath of CA will predict neurological prognosis at 3 months with high sensitivity and specificity.
Read the detailed description
Evaluating the prognosis of comatose participants after cardiac arrest (CA) in the intensive care unit remains challenging. It requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations: 1 / the electroencephalogram, bad prognosis assessed when the electroencephalogram (EEG) is discontinuous, areactive, monotone,…), 2 / somesthetic evoked potentials, the absence of the N20 cortical wave has a specificity of poor prognosis of 68-100% and 3 / auditory evoked potentials (AEP), the presence of mismatchnegativity (MMN) would be of good prognosis with a specificity up to 90% but rarely performed in current practice. Routinely, these examinations are sometimes difficult to interpret in sedated participants, in an intensive care unit environment that generates numerous artefacts. Above all, all these techniques require the presence of a neurophysiology unit, with few experts available.
In a preliminary study, in collaboration with the applied mathematics laboratory of the ENS (Ecole Normale Supérieure), an algorithm was developed from the signal extracted from AEP. A probability map was generated with a software allowing to visually classify the participants after processing signal by the algorithm in a cluster of points with a high specificity into "good neurological prognosis" and "bad neurological prognosis". Neither artifacts or sedation prevented data analysis.
The investigators hypothesize that the "PRECOM" tool, applied blindly to a large prospective multicenter cohort of participants admitted to intensive care for coma in the aftermath of a caridiac arrest will predict the neurological prognosis of participants with high sensitivity and specificity. This tool, carried out during the first week of the coma, will be compared to a standardized procedure used routinely by the participating resuscitators.
- Conditions
- Coma, Heart Arrest, Cardiopulmonary Resuscitation
- Being tested
- Neurological prognosis
- Keywords
- Post cardiac arrest for comatose patients, Electroencephalography, Somatosensory evoked potentials, Auditory evoked potentials, Prognosis, Algorithms, Classification
- Medical subject headings
- Coma, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological prognosisOther
In usual practice, in intensive care unit, evaluating the neurological prognosis of comatose patients after cardiac arrest requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations (among them auditive evoked potentials or AEP).
An algorithm (PRECOM tool) which has been previously developed from the signal extracted from AEP allows to visually classify the patients after processing signal by the algorithm in a cluster of points with a high specificity into "good neurological prognosis" and "bad neurological prognosis".
The AEP signals recorded in the 1st and 2nd week of patient inclusion are to be collected by the neurophysiologist. At the end of the patient's participation in the study, these data will be encrypted, anonymized and transmitted to the mathematician to be processed by the PRECOM tool.
| Study group | Role | What they receive |
|---|---|---|
| Comatose patients in intensive care unit | Patient admitted in the intensive care unit (ICU) for post cardiac arrest (CA) coma, persistent for at least 3 days after CA. Receives: Other: Neurological prognosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awakening within 3 months
Awakening is defined as normal motor activity in response to the 3 instructions for the motor component M of the FOUR score (show your thumb, make the V for victory and show your fist; M = 4). This criterion will be collected by the doctor in charge of the patient at the time of the assessment and will be dated.
Measured: within 3 months ± 2 weeks after inclusion
Secondary outcomes (17)
CPC score within 3 months
CPC (Cerebral Performance Category) score is performed wether patient is still hospitalized or returned home. It is performed by phone call if patient returned home.
Range of values rates neurological status after cardiac arrest on a scale of 1 to 5 (1 for good cerebral performance up to 5 for brain death).
Measured: 3 months ± 2 weeks after inclusion
mRS score within 3 months
mRS (Modified Rankin Scale) scores is performed wether patient is still hospitalized or returned home. It is performed by phone call if patient returned home.
mRS (modified Rankin Scale) scale measures degree of disability/dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Score can be between 0 (no symptoms at all) and 5 (major disability : bedridden, incontinent and requiring constant nursing care and attention).
Measured: 3 months ± 2 weeks after inclusion
FOUR score within 3 months
FOUR (Full Outline of UnResponsiveness) score is performed only if patient is still hospitalized (being awake or not).
FOUR score is a grading scale for assessing the level of consciousness performed on patients with severe neurologic impairment..It addresses four domains of neurological functioning: Eye response; Motor response ; Brainstem score and Respiratory score.
Score is ranging from 0 to 16 where the lower the score, the greater the coma gravity.
Measured: 3 months ± 2 weeks after inclusion
GOSE score within 3 months
GOSE (Extended Glasgow Outcome Scale) score is performed wether patient is still hospitalized or returned home.
GOSE score classifies global outcomes in traumatic brain injury survivors. It rates patient status into one of eight categories ranging from 8 (Upper good recovery) to 1 (Dead).
Measured: 3 months ± 2 weeks after inclusion
CPC score within 6 months
CPC (Cerebral Performance Category) score is performed wether patient is still hospitalized or returned home. It is performed by phone call if patient returned home.
Range of values rates neurological status after cardiac arrest on a scale of 1 to 5 (1 for good cerebral performance up to 5 for brain death).
Measured: 6 months ± 2 weeks after inclusion
mRS score within 6 months
mRS (Modified Rankin Scale) scores is performed wether patient is still hospitalized or returned home. It is performed by phone call if patient returned home.
mRS (modified Rankin Scale) scale measures degree of disability/dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Score can be between 0 (no symptoms at all) and 5 (major disability : bedridden, incontinent and requiring constant nursing care and attention).
Measured: within 6 months ± 2 weeks after inclusion
GOSE score within 6 months
GOSE (Extended Glasgow Outcome Scale) score is performed wether patient is still hospitalized or returned home.
GOSE score classifies global outcomes in traumatic brain injury survivors. It rates patient status into one of eight categories ranging from 8 (Upper good recovery) to 1 (Dead).
Measured: within 6 months ± 2 weeks after inclusion
Awakening within 6 months ± 2 weeks
Awakening is defined as normal motor activity in response to the 3 instructions for the motor component M of the FOUR score (show your thumb, make the V for victory and show your fist; M = 4). This criterion will be collected by the doctor in charge of the patient at the time of the assessment and will be dated. The measurement takes place only if patient is still hospitalized.
Measured: within 6 months ± 2 weeks after inclusion
CRS-R score within 6 months
CRS-R (Coma Recovery Scale - Revised) is a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. The scale is intented to be used to establish diagnosis, monitor behavioral recovery and predict outcome. It is performed only if patient is still hospitalized.
The total score ranges between 0 (worst) and 23 (best).
Measured: within 6 months ± 2 weeks after inclusion
PRECOM tool - first week of coma
Comparison of the ability of the PRECOM tool using clinical and electrophysiological data at inclusion (the first week of coma), to classify patients with good prognosis, poor prognosis and indeterminate prognosis with respect to this same categorization using the usual evaluation criteria performed routinely by participating resuscitations (clinical examination and EEG for all and evoked potentials in addition for some).
Measured: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)
PRECOM tool - second week of coma
Comparison of the ability of the PRECOM tool using clinical and electrophysiological data the second week of coma, to classify patients with good prognosis, poor prognosis and indeterminate prognosis with respect to this same categorization using the usual evaluation criteria performed routinely by participating resuscitations (clinical examination and EEG for all and evoked potentials in addition for some).
Measured: One week visit (one week after inclusion visit +/- 2 days)
PRECOM tool - first and second week of coma
Comparison of the ability of the PRECOM tool using combinaison of clinical and electrophysiological data collected both at inclusion and one week later (the first two weeks of coma), to classify patients with good prognosis, poor prognosis and indeterminate prognosis with respect to this same categorization using the usual evaluation criteria performed routinely by participating resuscitations (clinical examination and EEG for all and evoked potentials in addition for some).
Measured: Inclusion and one week visits
Awakening - second week of coma
Awakening is defined as normal motor activity in response to the 3 instructions for the motor component M of the FOUR score (show your thumb, make the V for victory and show your fist; M = 4). This criterion will be collected by the doctor in charge of the patient at the time of the assessment and will be dated.
Measured: One week visit (one week after inclusion visit +/- 2 days)
NSE blood marker
Comparison of the ability to predict awakening with the PRECOM tool using the NSE blood marker (neuron- spécific enolase) collected 3 days after cardiac arrest between the patients awakened from the coma and those who are not.
Measured: 3 days post cardiac arrest
Glial blood markor
Comparison of the ability to predict awakening with the PRECOM tool using the Glial Fibrillary Acidic Protein (GFAP) collected at the inclusion visit between the patients awakened from the coma and those who are not.
Measured: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)
Neuronal blood markor
Comparison of the ability to predict awakening with the PRECOM tool using the Neurofilament blood marker collected at the inclusion visit between the patients awakened from the coma and those who are not.
Measured: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)
Inflammatory blood markor
Comparison of the ability to predict awakening with the PRECOM tool using the inflammatory blood markers : Kynurenine and Tryptophan; collected at the inclusion visit between the patients awakened from the coma and those who are not.
Measured: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start15 Nov 2023
- Primary completion1 Mar 2028 (estimated)
- Study completion29 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Normale Supérieure de Paris
- Responsible party
- Sponsor
- Investigators
- Nathalie KUBIS, Md,PhD, Study director, APHP Lariboisière Hospital, Clinical Physiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321459
- Sponsor's protocol ID
- AOR 20045
- Acronym
- PRECOM
- Status last verified
- Dec 2025
- First submitted
- 14 Mar 2022
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Predictive Tool of Awakening in Comatose Patients in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05321459
- Acronym / sponsor ID
- PRECOM / AOR 20045
- Conditions
- Coma, Heart Arrest, Cardiopulmonary Resuscitation
- Keywords
- Post cardiac arrest for comatose patients, Electroencephalography, Somatosensory evoked potentials, Auditory evoked potentials, Prognosis, Algorithms, Classification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ecole Normale Supérieure de Paris
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 29 May 2028 (estimated)
- First posted
- 11 Apr 2022 (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.
Evaluating the prognosis of comatose patients after cardiac arrest (CA) in the intensive care unit (ICU) remains challenging. It requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations, (among them auditive evoked potentials or AEP) but none has a sufficient sensitivity/specificity. In a preliminary study, the investigators developed an algorithm from the signal collected with AEP, and generated a probability map to visually classify the participants after the algorithm processing. Participants could be classified either with a good neurological prognosis or with bad neurological prognosis or death.
The investigators hypothesize that the "PRECOM" tool, applied blindly to a large prospective multicenter cohort of patients admitted to intensive care for coma in the aftermath of CA will predict neurological prognosis at 3 months with high sensitivity and specificity.
Detailed description
Evaluating the prognosis of comatose participants after cardiac arrest (CA) in the intensive care unit remains challenging. It requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations: 1 / the electroencephalogram, bad prognosis assessed when the electroencephalogram (EEG) is discontinuous, areactive, monotone,…), 2 / somesthetic evoked potentials, the absence of the N20 cortical wave has a specificity of poor prognosis of 68-100% and 3 / auditory evoked potentials (AEP), the presence of mismatchnegativity (MMN) would be of good prognosis with a specificity up to 90% but rarely performed in current practice. Routinely, these examinations are sometimes difficult to interpret in sedated participants, in an intensive care unit environment that generates numerous artefacts. Above all, all these techniques require the presence of a neurophysiology unit, with few experts available.
In a preliminary study, in collaboration with the applied mathematics laboratory of the ENS (Ecole Normale Supérieure), an algorithm was developed from the signal extracted from AEP. A probability map was generated with a software allowing to visually classify the participants after processing signal by the algorithm in a cluster of points with a high specificity into "good neurological prognosis" and "bad neurological prognosis". Neither artifacts or sedation prevented data analysis.
The investigators hypothesize that the "PRECOM" tool, applied blindly to a large prospective multicenter cohort of participants admitted to intensive care for coma in the aftermath of a caridiac arrest will predict the neurological prognosis of participants with high sensitivity and specificity. This tool, carried out during the first week of the coma, will be compared to a standardized procedure used routinely by the participating resuscitators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comatose patients in intensive care unit | – | Other: Neurological prognosisPatient admitted in the intensive care unit (ICU) for post cardiac arrest (CA) coma, persistent for at least 3 days after CA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to intensive care following a cardica arrest.
Key inclusion criteria (4 listed)
- Age above18 years old
- Patient affiliated to a French Heath Care Insurance
- Admitted in the intensive care unit (ICU) for coma post extra- or intra-hospital cardiac arrest (CA) with shockable or non-shockable rhythm
- Persistent coma on day 3 after post CA, defined by the inability to respond to a verbal command in an appropriate manner (motor Glasgow components ≤ 3) and at the time of neurophysiological recordings (D3-D7 ± week -end).
Key exclusion criteria (3 listed)
- Decision to limit resuscitation therapies taken by the resuscitation team
- Inability to perform the auditory evoked potentials (AEP) (deafness, skin lesion or any condition preventing to record AEP).
- Opposition by the trusted person or by the patient once he/she wakes up
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 |
|---|---|---|
| Neurological prognosisIn usual practice, in intensive care unit, evaluating the neurological prognosis of comatose patients after cardiac arrest requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations (among them auditive evoked potentials or AEP). An algorithm (PRECOM tool) which has been previously developed from the signal extracted from AEP allows to visually classify the patients after processing signal by the algorithm in a cluster of points with a high specificity into "good neurological prognosis" and "bad neurological prognosis". The AEP signals recorded in the 1st and 2nd week of patient inclusion are to be collected by the neurophysiologist. At the end of the patient's participation in the study, these data will be encrypted, anonymized and transmitted to the mathematician to be processed by the PRECOM tool. | Other | Comatose patients in intensive care unit |
Primary outcome
Awakening within 3 months
Time frame: within 3 months ± 2 weeks after inclusion
Awakening is defined as normal motor activity in response to the 3 instructions for the motor component M of the FOUR score (show your thumb, make the V for victory and show your fist; M = 4). This criterion will be collected by the doctor in charge of the patient at the time of the assessment and will be dated.
17 secondary outcomes
CPC score within 3 months
Time frame: 3 months ± 2 weeks after inclusion
mRS score within 3 months
Time frame: 3 months ± 2 weeks after inclusion
FOUR score within 3 months
Time frame: 3 months ± 2 weeks after inclusion
GOSE score within 3 months
Time frame: 3 months ± 2 weeks after inclusion
CPC score within 6 months
Time frame: 6 months ± 2 weeks after inclusion
mRS score within 6 months
Time frame: within 6 months ± 2 weeks after inclusion
GOSE score within 6 months
Time frame: within 6 months ± 2 weeks after inclusion
Awakening within 6 months ± 2 weeks
Time frame: within 6 months ± 2 weeks after inclusion
CRS-R score within 6 months
Time frame: within 6 months ± 2 weeks after inclusion
PRECOM tool - first week of coma
Time frame: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)
PRECOM tool - second week of coma
Time frame: One week visit (one week after inclusion visit +/- 2 days)
PRECOM tool - first and second week of coma
Time frame: Inclusion and one week visits
Awakening - second week of coma
Time frame: One week visit (one week after inclusion visit +/- 2 days)
NSE blood marker
Time frame: 3 days post cardiac arrest
Glial blood markor
Time frame: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)
Neuronal blood markor
Time frame: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)
Inflammatory blood markor
Time frame: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)
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 23 Dec 2025.
- 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.
Nathalie KUBIS, Md,PhD study director
APHP Lariboisière Hospital, Clinical Physiology Department
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coma and Heart Arrest, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
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 3 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: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
Contact Nathalie KUBIS, Md, PhD (+33(0)149958324, nathalie.kubis@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awakening within 3 months (time frame: within 3 months ± 2 weeks after inclusion). 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 23 Dec 2025.