Addiction, SubstancePAWSS-VFNCT06675539
Validation of the French Version of the Prediction of the Alcohol Withdrawal Severity Scale (PAWSS)
An observational study of Addiction, Substance and Alcohol Use Disorder, run by Etablissement Public de Santé Barthélemy Durand at 1 site in France.
Trial summary
The goal of this observational study is to validate the French version of the PAWSS scale in a population of patients with Alcohol Use Disorders. Prediction of Alcohol Withdrawal Severity Scale (PAWSS) has an excellent psychometric characteristics and predictive value of complicated alcohol withdrawal. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Addiction, Substance, Alcohol Use Disorder, Alcohol Dependence
- What is being tested?
- French version PAWSS
- How many people
- 545 participants
- Where
- 1 siteFrance
- Study dates
- 11 Nov 2024to Oct 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: AUD adults subjects hospitalized
Who may be able to join
- Male or female, aged 18 to 60 years
- Subjects with DSM-5 criteria for alcohol use disorders (AUD)
- Subjects hospitalized for scheduled withdrawal or patients developing alcohol withdrawal hospitalized for another reason.
- Subjects who understand French
- Subject affiliated to the French social security system
- Subject having given their written consent to the study
Who cannot join
- Subjects transferred from other hospitalization services for whom a withdrawal syndrome could have already been treated.
- Subjects scheduled for discharge within 48 hours.
- Subjects with known uncontrolled epilepsy.
- Subjects unable to understand the questionnaire.
- Subjects unable to give consent or not volunteering for the study.
- Subjects under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Etablissement Public de Santé Barthélemy Durand
Étampes, 91150
Adelaide Aduayi, +33 175021681, adelaide.aduayi@eps-etampes.fr
Manon Bayle--berard, +33 1 69 92 52 52, manon.bayle--berard@eps-etampes.fr
About this study
The goal of this observational study is to validate the French version of the PAWSS scale in a population of patients with Alcohol Use Disorders. Prediction of Alcohol Withdrawal Severity Scale (PAWSS) has an excellent psychometric characteristics and predictive value of complicated alcohol withdrawal.
The main question it aims to answer is:
Read more
Are the psychometric properties of the French version of the PAWSS scale comparable to those of the English version in a population of alcohol use disorders subjects?
AUDs participants are included and followed for three days during their hospitalization, They will performed several scales and surveys (DSM-5 AUD criteria, AUDIT, French version of PAWSS and CIWA-AR).
Read the detailed description
Context Alcohol use disorders (AUDs) are reported in 10-32% of hospitalized medical patients [Nielsen et al. 1994; Smothers et al. 2004; Dolman and Hawkes 2005; Doering-Silveira et al. 2014], in 23 % of hospitalized medical patients and in 25-50% of hospitalized psychiatric patients in France [Paille \& Reynaud 2015]. A hospital admission may result in an abrupt cessation of alcohol consumption for individuals with AUD and thus provide a risk period for alcohol withdrawal syndrome. Even though the majority of patients at risk of AWS will develop only minor or uncomplicated withdrawal symptoms, up to 20% of patients develop symptoms associated with complicated alcohol withdrawal, including withdrawal seizures and delirium tremens [Maldonado et al., 2010]. Complicated alcohol withdrawal syndrome is associated with increased in-hospital morbidity and mortality, increased lengths of stay, inflated costs of care, and worsened cognitive functioning.
Due to lack of any similar previously existing tools, Maldonado et al. developed the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) [Maldonado et al. 2014, 2015]. The PAWSS scale has excellent psychometric characteristics and predictive value of complicated alcohol withdrawal among medically ill hospitalized patients using a PAWSS cutoff of 4, the tool's sensitivity was 93.1% and specificity was 99.5%. The PAWSS scale is recommended by the American Society of Addiction Medicine for alcohol withdrawal management, (ASAM 2020, www.asam.org).
There is no scale available to identify the patients at risk of complicated withdrawal In France. The PAWSS is not a withdrawal severity scale such as the CIWA-AR or Cushman scale, which are scored during withdrawal, but a scale designed to screen beforehand, prior to withdrawal, patients at high risk for the most severe complications (Delirium tremens and seizures), and thus to take appropriate therapeutic measures. It also has the advantage of being able to guide patients towards the most suitable scheduled withdrawal modalities for their condition.
The PAWSS can therefore greatly assist clinicians in directing patients to either outpatient or hospital withdrawal in more or less intensive care, with a minimum of risk. Its use would allow earlier management to limit the sequelae, especially cognitive and those related to seizures.
The PAWSS scale includes an initial screener question and can be used with patients who are not currently exhibiting signs of withdrawal. If a patient does indeed endorse recent intake of alcohol, this must be followed by 10 questions contained in the second part of PAWSS, assessing known risk factors for withdrawal and current clinical status. The PAWSS is heavily based on self-report of alcohol intake and history provided by patients, as the literature suggests that interviews by clinicians can provide the most accurate information on alcohol abuse and relapse, as compared to collateral information or selected laboratory data.
Objectives The primary objective is to validate the French version of the PAWSS scale (PRSAC) in a population of patients with AUD.
The secondary objectives are 1) to confirm the optimal cut-off score of 4 for the PRSAC scale, 2) to evaluate PRSAC scale reproducibility in predicting the risk of complicated alcohol withdrawal syndrome and 3) to identify an optimal strategy for benzodiazepine use following the application of PRSAC scale.
Hypothesis Are the psychometric properties of the French version of the PAWSS scale (PRSAC) comparable to those of the English version in a population of alcohol use disorders subjects?
Methods This study is a multicentric non-interventional prospective cohort study. Subject evaluation included during 3 days.
Day 1: Collection of consent and clinical data, DSM-5 criterion for alcohol use disorders, AUDIT, PRSAC scale (twice by two investigators), and CIWA-AR scale every 8 hours.
Day 2 and Day 3: administration of CIWA-AR scale every 8 hours.
Inclusion criteria Male or female, aged 18 to 60 years Subjects with DSM-5 criteria for moderate to severe alcohol use disorders (AUD) Subjects hospitalized for AUD or another condition with AUD. Subjects who understand French and affiliated to the social security system
Non-inclusion criteria Subject with a neurological disorder, impairing cognition (epilepsy, dementia,…) Subjects unable to understand the questionnaire and to give consent or not volunteering for the study Subject under guardianship or curatorship
Study location
Academic substance abuse treatment and Psychiatry departments of:
Barthélemy Durand Hospital at Etampes, France Paul Brousse hospital in Villejuif, France Rouen university hospital, France Caen university hospital, France Martinique university hospital, France
Results \& Outcome Confirmation of the psychometric qualities of the French version of the PAWSS scale.
- Being tested
- French version PAWSS
- Keywords
- Alcohol Use Disorder, Scale, alcohol withdrawal, prediction, withdrawal syndrome
- Medical subject headings
- Substance-Related Disorders, Alcoholism, Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
French version PAWSSDiagnostic test
French version of the Prediction of Alcohol Withdrawal Severity Scale
| Study group | Role | What they receive |
|---|---|---|
| AUD participant | Subject evaluation included during 3 days.
Day 1: Collection of consent and clinical data, DSM-5 criterion for alcohol use disorders, AUDIT, PRSAC scale (twice by two investigators), and CIWA-AR scale every 8 hours.
Day 2 and Day 3: administration of CIWA-AR scale every 8 hours. Receives: Diagnostic Test: French version PAWSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric qualities evaluation of French PAWSS
The primary endpoint is the evaluation of the psychometric qualities of the French version of PAWSS scale (PRSAC) by measuring predictive performance through the calculation of sensitivity, specificity, and positive and negative predictive values.
Measured: 3 days
Secondary outcomes (3)
The optimal cut-off score of 4 for the French version of the Prediction of the Alcohol Withdrawal Severity Scale
The optimal cut-off score of 4 will be determined by ROC curve analysis to confirm the cut-off for the French version of the Prediction of Alcohol Withdrawal Severity Scale. A French version of the Prediction of the Alcohol Withdrawal Severity Scale score of 4 or higher indicates a high risk of developing a complicated withdrawal syndrome.
Measured: 3 days
Reproducibility in predicting the risk of French PAWSS
Evaluate the reproducibility of the French version of the Prediction of the Alcohol Withdrawal Severity Scale in predicting the risk of complicated alcohol withdrawal syndrome by measuring inter-rater reliability through the calculation of Cohen's Kappa and Lin's concordance coefficients.
Measured: 3 days
Doses and Durations of Benzodiazepine
The doses and durations of benzodiazepine use during the study are collected during each participant's involvement in the study. These doses and durations will be compared between a group with a score below 4 and a group with a score of 4 or higher on the French version of the Prediction of Alcohol Withdrawal Severity Scale
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start11 Nov 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Addiction, SubstanceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 545 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Etablissement Public de Santé Barthélemy Durand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Dervaux, Principal investigator, Etablissement Public de Santé Barthélemy Durand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675539
- Sponsor's protocol ID
- 24P04
- Other IDs
- 2022-A01364-39
- Acronym
- PAWSS-VF
- Status last verified
- Feb 2025
- First submitted
- 30 Sep 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maldonado JR, Sher Y, Das S, Hills-Evans K, Frenklach A, Lolak S, Talley R, Neri E. Prospective Validation Study of the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) in Medically Ill Inpatients: A New Scale for the Prediction of Complicated Alcohol Withdrawal Syndrome. Alcohol Alcohol. 2015 Sep;50(5):509-18. doi: 10.1093/alcalc/agv043. Epub 2015 May 21.
PubMed 25999438Maldonado JR, Sher Y, Ashouri JF, Hills-Evans K, Swendsen H, Lolak S, Miller AC. The "Prediction of Alcohol Withdrawal Severity Scale" (PAWSS): systematic literature review and pilot study of a new scale for the prediction of complicated alcohol withdrawal syndrome. Alcohol. 2014 Jun;48(4):375-90. doi: 10.1016/j.alcohol.2014.01.004. Epub 2014 Feb 19.
PubMed 24657098Campos J, Roca L, Gude F, Gonzalez-Quintela A. Long-term mortality of patients admitted to the hospital with alcohol withdrawal syndrome. Alcohol Clin Exp Res. 2011 Jun;35(6):1180-6. doi: 10.1111/j.1530-0277.2011.01451.x. Epub 2011 Feb 25.
PubMed 21352245Eloma AS, Tucciarone JM, Hayes EM, Bronson BD. Evaluation of the appropriate use of a CIWA-Ar alcohol withdrawal protocol in the general hospital setting. Am J Drug Alcohol Abuse. 2018;44(4):418-425. doi: 10.1080/00952990.2017.1362418. Epub 2017 Oct 5.
PubMed 28981333Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.
PubMed 2597811
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the Prediction of the Alcohol Withdrawal Severity Scale (PAWSS)
- ClinicalTrials.gov ID
- NCT06675539
- Acronym / sponsor ID
- PAWSS-VF / 24P04
- Keywords
- Alcohol Use Disorder, Scale, alcohol withdrawal, prediction, withdrawal syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 545 participants (estimated)
- Lead sponsor
- Etablissement Public de Santé Barthélemy DurandUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 5 Nov 2024 (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.
The goal of this observational study is to validate the French version of the PAWSS scale in a population of patients with Alcohol Use Disorders. Prediction of Alcohol Withdrawal Severity Scale (PAWSS) has an excellent psychometric characteristics and predictive value of complicated alcohol withdrawal.
The main question it aims to answer is:
Are the psychometric properties of the French version of the PAWSS scale comparable to those of the English version in a population of alcohol use disorders subjects?
AUDs participants are included and followed for three days during their hospitalization, They will performed several scales and surveys (DSM-5 AUD criteria, AUDIT, French version of PAWSS and CIWA-AR).
Detailed description
Context Alcohol use disorders (AUDs) are reported in 10-32% of hospitalized medical patients [Nielsen et al. 1994; Smothers et al. 2004; Dolman and Hawkes 2005; Doering-Silveira et al. 2014], in 23 % of hospitalized medical patients and in 25-50% of hospitalized psychiatric patients in France [Paille \& Reynaud 2015]. A hospital admission may result in an abrupt cessation of alcohol consumption for individuals with AUD and thus provide a risk period for alcohol withdrawal syndrome. Even though the majority of patients at risk of AWS will develop only minor or uncomplicated withdrawal symptoms, up to 20% of patients develop symptoms associated with complicated alcohol withdrawal, including withdrawal seizures and delirium tremens [Maldonado et al., 2010]. Complicated alcohol withdrawal syndrome is associated with increased in-hospital morbidity and mortality, increased lengths of stay, inflated costs of care, and worsened cognitive functioning.
Due to lack of any similar previously existing tools, Maldonado et al. developed the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) [Maldonado et al. 2014, 2015]. The PAWSS scale has excellent psychometric characteristics and predictive value of complicated alcohol withdrawal among medically ill hospitalized patients using a PAWSS cutoff of 4, the tool's sensitivity was 93.1% and specificity was 99.5%. The PAWSS scale is recommended by the American Society of Addiction Medicine for alcohol withdrawal management, (ASAM 2020, www.asam.org).
There is no scale available to identify the patients at risk of complicated withdrawal In France. The PAWSS is not a withdrawal severity scale such as the CIWA-AR or Cushman scale, which are scored during withdrawal, but a scale designed to screen beforehand, prior to withdrawal, patients at high risk for the most severe complications (Delirium tremens and seizures), and thus to take appropriate therapeutic measures. It also has the advantage of being able to guide patients towards the most suitable scheduled withdrawal modalities for their condition.
The PAWSS can therefore greatly assist clinicians in directing patients to either outpatient or hospital withdrawal in more or less intensive care, with a minimum of risk. Its use would allow earlier management to limit the sequelae, especially cognitive and those related to seizures.
The PAWSS scale includes an initial screener question and can be used with patients who are not currently exhibiting signs of withdrawal. If a patient does indeed endorse recent intake of alcohol, this must be followed by 10 questions contained in the second part of PAWSS, assessing known risk factors for withdrawal and current clinical status. The PAWSS is heavily based on self-report of alcohol intake and history provided by patients, as the literature suggests that interviews by clinicians can provide the most accurate information on alcohol abuse and relapse, as compared to collateral information or selected laboratory data.
Objectives The primary objective is to validate the French version of the PAWSS scale (PRSAC) in a population of patients with AUD.
The secondary objectives are 1) to confirm the optimal cut-off score of 4 for the PRSAC scale, 2) to evaluate PRSAC scale reproducibility in predicting the risk of complicated alcohol withdrawal syndrome and 3) to identify an optimal strategy for benzodiazepine use following the application of PRSAC scale.
Hypothesis Are the psychometric properties of the French version of the PAWSS scale (PRSAC) comparable to those of the English version in a population of alcohol use disorders subjects?
Methods This study is a multicentric non-interventional prospective cohort study. Subject evaluation included during 3 days.
Day 1: Collection of consent and clinical data, DSM-5 criterion for alcohol use disorders, AUDIT, PRSAC scale (twice by two investigators), and CIWA-AR scale every 8 hours.
Day 2 and Day 3: administration of CIWA-AR scale every 8 hours.
Inclusion criteria Male or female, aged 18 to 60 years Subjects with DSM-5 criteria for moderate to severe alcohol use disorders (AUD) Subjects hospitalized for AUD or another condition with AUD. Subjects who understand French and affiliated to the social security system
Non-inclusion criteria Subject with a neurological disorder, impairing cognition (epilepsy, dementia,…) Subjects unable to understand the questionnaire and to give consent or not volunteering for the study Subject under guardianship or curatorship
Study location
Academic substance abuse treatment and Psychiatry departments of:
Barthélemy Durand Hospital at Etampes, France Paul Brousse hospital in Villejuif, France Rouen university hospital, France Caen university hospital, France Martinique university hospital, France
Results \& Outcome Confirmation of the psychometric qualities of the French version of the PAWSS scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUD participant | – | Diagnostic Test: French version PAWSSSubject evaluation included during 3 days. Day 1: Collection of consent and clinical data, DSM-5 criterion for alcohol use disorders, AUDIT, PRSAC scale (twice by two investigators), and CIWA-AR scale every 8 hours. Day 2 and Day 3: administration of CIWA-AR scale every 8 hours. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- AUD adults subjects hospitalized
Key inclusion criteria (6 listed)
- Male or female, aged 18 to 60 years
- Subjects with DSM-5 criteria for alcohol use disorders (AUD)
- Subjects hospitalized for scheduled withdrawal or patients developing alcohol withdrawal hospitalized for another reason.
- Subjects who understand French
- Subject affiliated to the French social security system
Key exclusion criteria (6 listed)
- Subjects transferred from other hospitalization services for whom a withdrawal syndrome could have already been treated.
- Subjects scheduled for discharge within 48 hours.
- Subjects with known uncontrolled epilepsy.
- Subjects unable to understand the questionnaire.
- Subjects unable to give consent or not volunteering for the study.
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 |
|---|---|---|
| French version PAWSSFrench version of the Prediction of Alcohol Withdrawal Severity Scale | Diagnostic test | AUD participant |
Primary outcome
Psychometric qualities evaluation of French PAWSS
Time frame: 3 days
The primary endpoint is the evaluation of the psychometric qualities of the French version of PAWSS scale (PRSAC) by measuring predictive performance through the calculation of sensitivity, specificity, and positive and negative predictive values.
3 secondary outcomes
The optimal cut-off score of 4 for the French version of the Prediction of the Alcohol Withdrawal Severity Scale
Time frame: 3 days
Reproducibility in predicting the risk of French PAWSS
Time frame: 3 days
Doses and Durations of Benzodiazepine
Time frame: 3 days
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 25 Feb 2025.
- Background: PubMed 25999438Maldonado JR, Sher Y, Das S, Hills-Evans K, Frenklach A, Lolak S, Talley R, Neri E. Prospective Validation Study of the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) in Medically Ill Inpatients: A New Scale for the Prediction of Complicated Alcohol Withdrawal Syndrome. Alcohol Alcohol. 2015 Sep;50(5):509-18. doi: 10.1093/alcalc/agv043. Epub 2015 May 21.
- Background: PubMed 24657098Maldonado JR, Sher Y, Ashouri JF, Hills-Evans K, Swendsen H, Lolak S, Miller AC. The "Prediction of Alcohol Withdrawal Severity Scale" (PAWSS): systematic literature review and pilot study of a new scale for the prediction of complicated alcohol withdrawal syndrome. Alcohol. 2014 Jun;48(4):375-90. doi: 10.1016/j.alcohol.2014.01.004. Epub 2014 Feb 19.
- Background: PubMed 21352245Campos J, Roca L, Gude F, Gonzalez-Quintela A. Long-term mortality of patients admitted to the hospital with alcohol withdrawal syndrome. Alcohol Clin Exp Res. 2011 Jun;35(6):1180-6. doi: 10.1111/j.1530-0277.2011.01451.x. Epub 2011 Feb 25.
- Background: PubMed 28981333Eloma AS, Tucciarone JM, Hayes EM, Bronson BD. Evaluation of the appropriate use of a CIWA-Ar alcohol withdrawal protocol in the general hospital setting. Am J Drug Alcohol Abuse. 2018;44(4):418-425. doi: 10.1080/00952990.2017.1362418. Epub 2017 Oct 5.
- Background: PubMed 2597811Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.
- 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.
Alain Dervaux principal investigator
Etablissement Public de Santé Barthélemy Durand
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 Addiction, Substance and Alcohol Use Disorder, run by Etablissement Public de Santé Barthélemy Durand at 1 site 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 6 inclusion and 6 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 25 Feb 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 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 Adelaide Aduayi (+33 1 75 02 16 81, adelaide.aduayi@eps-etampes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric qualities evaluation of French PAWSS (time frame: 3 days). 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 NCT06675539, which also lists 5 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 25 Feb 2025.