Primary PolydipsiaCOPEPCHILDNCT06604975
Arginin-stimulated Copeptin in Polyuria-polydipsia Syndrome in Children
A study testing Measure of Basal Copeptin level, Measure of arginine-stimulated copeptin and IRM in people with Primary Polydipsia and Central Diabetes Insipidus, run by Assistance Publique Hopitaux De Marseille at 14 sites in France.
Trial summary
The exploration of polyuro-polydipsia syndrome (PPS) with hypotonic polyuria should distinguished, primary polydipsia (PP) due to excessive water intake, central diabetes insipidus (CDI) related to insufficient secretion of antidiuretic hormone (AVP), and nephrogenic diabetes insipidus (NDI) related to AVP… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Primary Polydipsia, Central Diabetes Insipidus, Nephrogenic Diabetes Insipidus
- What is being tested?
- Measure of Basal Copeptin level, Measure of arginine-stimulated copeptin and IRM
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 14 sitesFrance
- Study dates
- Mar 2025to Jul 2028
- Phase
- Interventional
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 2 to 18 years with polyuro-polydipsia syndrome (defined as hypotonic diuresis \> 50 mL/kg/day in pediatric age or 30 mL/kg/day in late puberty (Tanner 5)) presenting for differential diagnosis between PP and DIC
- Basal copeptin of less than 30 pmol/l
- Agreeing to participate in the study
- Whose two parents' consent to have their child participate in the study.
Who cannot join
- Diabetes mellitus
- Unbalanced dysthyroidism
- Corticotropic deficiency
- Ionic disorders (dysnatremia \< 135 or \> 145 mmol/l, dyskalemia \< 3 or \> 5 mmol/l, corrected dyscalcemia \< 2.2 or \> 2.6 mmol/L)
- Moderate to severe clinical dehydration (recent weight loss \> 5% of body weight, clinical or biological signs of dehydration) requiring immediate therapeutic management
- Renal failure with GFR \< 60 mL/min/1.73 m2
Show all 17Show fewer
- Uropathy
- Tumor syndrome (except hypothalamo-pituitary tumor)
- Intracranial hypertension
- ROHHAD syndrome
- Fever or biological inflammatory syndrome with CRP \> 5 mg/L
- Hepatic insufficiency
- Contraindication to MRI
- Contraindication to progressive water intake restrictions
- History of contraindication to arginine
- Positive test for Pregnancy
- Lack of authorization by both parents or legal representatives
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Rawand MASOUD contact
14 sites in 1 country
France14 sites
CHU Angers
Angers
Régis COUTANT
CHU de Bordeaux
Bordeaux
Pascal BARAT
CHU Lille
Lille
Iva GUEORGUIEVA
HCL
Lyon
Carine VILLANUEVA
Assistance Publique Hopitaux de Marseille
Marseille
Rachel REYNAUD, 0491388040, Rachel.REYNAUD@ap-hm.fr
Rawand Masoud, rawand.masoud@ap-hm.fr
CHU Montpellier
Montpellier
Cyril AMOUROUX
CHU Nantes
Nantes
CHU Nice
Nice
AP-HP
Paris
Agnes LINGLART
CH Pau
Pau
Laure OILLEAU
CHU Reims
Reims
Pierre-François SOUCHON
CHU Rennes
Rennes
SAADE Marie Béatrice
CHU Rouen
Rouen
Mireille CASTANET
CHU Toulouse
Toulouse
Thomas EDOUARD
About this study
The exploration of polyuro-polydipsia syndrome (PPS) with hypotonic polyuria should distinguished, primary polydipsia (PP) due to excessive water intake, central diabetes insipidus (CDI) related to insufficient secretion of antidiuretic hormone (AVP), and nephrogenic diabetes insipidus (NDI) related to AVP insensitivity. The determination of plasma AVP is not relevant (unstable concentration, short in vitro half-life, long technical time and large blood sample). The differential diagnosis is currently based on a water deprivation test (WDT), an indirect reflection of AVP action, requiring more than 6 hours of hospitalization with risk of dehydration and low accuracy. Copeptin represents a new biomarker, direct mirror of AVP release with remarkable characteristics (stable, rapid determination, small blood volume). Copeptin has become a diagnostic tool in adult PPS and eliminated WDT in the diagnostic process. In children, basal copeptin values help for NDI and to exclude CDI (basal copeptin threshold > 30 and > 3.53 pmol/l (Se 100%, Sp 87.4%), respectively). Below 3.53 pmol/l, basal copeptin performance was inadequate to discriminate PP and CDI, highlighting the relevance of the stimulated copeptin study to improve this strategy. The arginine stimulation test is widely used as a simple, short duration (2 hours) and well tolerated tool to diagnose growth hormone deficiency in pediatrics. The performance of this test for copeptin stimulation was studied in adults with PPS with a high diagnostic accuracy.
The aim of the study is identify the best discriminant threshold of the arginine stimulation test in the uncertain diagnosis (basal copeptin <30 pmol/l) in the polyuro-polydipsic syndrome in children.
Then evaluate the discriminative capacities of the arginine stimulation test between the primary polydipsia and central insipid diabetes in the polyuro-polydipsic syndrome in children. And finally evaluate the cost-effectiveness of a new decisional algorithm for the differential diagnosis of PPS in children and evaluate the impact of infusion volume on copeptin secretion using the protidemia copeptin ratio.
Read the detailed description
Routine biochemical tests are performed to screen patients for PPS and determine basal copeptin level after solid fasting since midnight without water restriction: 1/ a basal copeptin value ≥ 30 pmol/L defines the diagnosis of NDI and results in a specific care; 2/ a basal copeptin < 30 pmol/L defines the group of eligible patients for arginine stimulation. The arginine-stimulated copeptin test start at 8 am, at the dose of 0.5 g/kg over 30min. Copeptin is measured at T0 (before infusion), T45, T60, T90, and T120 min after infusion.
Patients with basal copeptin value over 3.53 pmol/L are considered as positive diagnosis of PP (Se 100%, Sp 87.4%) and cerebral MRI is not performed for this group of patients (PP group).
Patients with basal copeptin value < 3.53 pmol/L are considered as an uncertain diagnosis (UD) and cerebral and pituitary MRI is performed with a least two independent interpretations. Abnormal pituitary MRI allows a diagnosis of CDI leading to etiological investigations and AVP treatment. Patients with basal copeptin ≥ 3.53 pmol/l (PP group), and UD patients with normal MRI have gradual reduction of water intake without AVP treatment. For all these latest patients, a clinical and biological reevaluation is performed one month later.
The gold standard will be the final diagnosis PP vs. CDI based on a set of indicators: medical history, physical examination, pituitary hormonal assessment, hypothalamo-pituitary MRI, follow-up at 1 month.
- Being tested
- Measure of Basal Copeptin level, Measure of arginine-stimulated copeptin, IRM, Water reduction at home
- Medical subject headings
- Polydipsia, Psychogenic, Diabetes Insipidus, Neurogenic, Diabetes Insipidus, Nephrogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of Basal Copeptin levelProcedure or surgery
Copeptin test is performed after solid fasting since midnight without water restriction. After blood collection on heparin tube used for biological inclusion criteria, heparinized plasma is transferred to Timone University hospital (transport temperature +4°C) for screening copeptin assay.
The basal copeptin level determines the next step:
- copeptin ≥ 30 pmol/L defines the diagnosis of NDI and results in a specific care;
- copeptin \< 30 pmol/L defines the group of eligible patients for arginine stimulation
Measure of arginine-stimulated copeptinProcedure or surgery
The arginine-stimulated copeptin test start at 8 am, after solid fasting since midnight without water restriction, and 30 min of rest in decubitus position. A dose of 0.5 g/kg of arginine (maximum 40g) diluted in 0.9% NaCl is infused over 30 min through a peripheral venous line. Copeptin is measured at T0 (before infusion), T45, T60, T90, and T120 min after infusion.
IRMProcedure or surgery
Based on our previous study, patients with basal copeptin value over 3.53 pmol/L are considered as positive diagnosis of PP (Se 100%, Sp 87.4%) and cerebral MRI is not performed for this group of patients (PP group).
A cerebral and pituitary MRI performed according to reference procedures (without and with contrast medium used in routine care) for patients considered as an uncertain diagnosis (UD) based on basal copeptin value (\&lt; 3.53 pmol/L). MRI interpretation is performed by two independent neuroradiologists (one from the recruiting center and one from the pilot center). In case of discrepancies, a third independent interpretation will be performed by a neuroradiologist from the coordinating center. Abnormal pituitary MRI (thickened pituitary stalk pituitary tumor, ectopic neurohypophysis, septo-optic dysplasia, empty sellar, Rathke pouch) allows a diagnosis of CDI leading to etiological investigations and AVP treatment.
Water reduction at homeBehavioural
Patients with basal copeptin ≥ 3.53 pmol/l (PP group), and UD patients with normal MRI have gradual reduction of water intake at home without AVP treatment : gradual reduction with 20% in the first week, 30% in the second, 40% in the third, reaching 50% of daily fluid in the last week including restriction overnight, deletion drink before sleep. Some recommendations will be provided to help physicians. For all these latest patients, a clinical reassessment (weight, height, heart rate, blood pressure, input/output 24 hours balance) is performed one month later.
| Study group | Role | What they receive |
|---|---|---|
| NDI-PP- CDI groups | Experimental | Copeptin represents a new biomarker, direct mirror of AVP release with remarkable characteristics (stable, rapid determination, small blood volume). Copeptin has become a diagnostic tool in adult PPS and eliminated WDT in the diagnostic process. In children, basal copeptin values help for NDI and to exclude CDI (basal copeptin threshold > 30 and >3.53 pmol/l (Se 100%, Sp 87.4%), respectively). Below 3.53 pmol/l, basal copeptin performance was inadequate to discriminate PP and CDI, highlighting the relevance of the stimulated copeptin study to improve this strategy. Receives: Procedure: Measure of Basal Copeptin level; Procedure: Measure of arginine-stimulated copeptin; Procedure: IRM; Behavioral: Water reduction at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of arginine-stimulated copeptine level
Determine arginine-stimulated copeptine level for each time (T45min, T60min, T90min, T120min)
Measured: Different time points of argenine stimulates copeptine level will be measured at 45 minutes, 60 minutes, 90 minutes and 120 minutes
Secondary outcomes (2)
Cost savings applying a new algorithm for the exploration of the Polyuria-polydipsia Syndrome using an Argenin-stimulated copeptin test
Evaluate the cost-effectiveness of a new decisional algorithm for the differential diagnosis of PPS in children including medications, examinations and length of stay at the hospital
Measured: Month 36
Copeptin Ratio
Evaluate the impact of infusion volume on copeptin secretion using the copeptin ratio (for each time, the arginine-stimulated copeptin ratio will be calculated in order to take count of the baseline copeptin concentration and in order to counteract any blood dilution due to perfusion copeptin ratio will be corrected by protidemia)
Measured: Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study startMar 2025 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary PolydipsiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel REYNAUD, Pr, Principal investigator, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604975
- Sponsor's protocol ID
- RCAPHM23_0379
- Acronym
- COPEPCHILD
- Status last verified
- Feb 2025
- First submitted
- 9 Sep 2024
- Last updated
- 13 Feb 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 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arginin-stimulated Copeptin in Polyuria-polydipsia Syndrome in Children
- ClinicalTrials.gov ID
- NCT06604975
- Acronym / sponsor ID
- COPEPCHILD / RCAPHM23_0379
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 20 Sep 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 exploration of polyuro-polydipsia syndrome (PPS) with hypotonic polyuria should distinguished, primary polydipsia (PP) due to excessive water intake, central diabetes insipidus (CDI) related to insufficient secretion of antidiuretic hormone (AVP), and nephrogenic diabetes insipidus (NDI) related to AVP insensitivity. The determination of plasma AVP is not relevant (unstable concentration, short in vitro half-life, long technical time and large blood sample). The differential diagnosis is currently based on a water deprivation test (WDT), an indirect reflection of AVP action, requiring more than 6 hours of hospitalization with risk of dehydration and low accuracy. Copeptin represents a new biomarker, direct mirror of AVP release with remarkable characteristics (stable, rapid determination, small blood volume). Copeptin has become a diagnostic tool in adult PPS and eliminated WDT in the diagnostic process. In children, basal copeptin values help for NDI and to exclude CDI (basal copeptin threshold > 30 and > 3.53 pmol/l (Se 100%, Sp 87.4%), respectively). Below 3.53 pmol/l, basal copeptin performance was inadequate to discriminate PP and CDI, highlighting the relevance of the stimulated copeptin study to improve this strategy. The arginine stimulation test is widely used as a simple, short duration (2 hours) and well tolerated tool to diagnose growth hormone deficiency in pediatrics. The performance of this test for copeptin stimulation was studied in adults with PPS with a high diagnostic accuracy.
The aim of the study is identify the best discriminant threshold of the arginine stimulation test in the uncertain diagnosis (basal copeptin <30 pmol/l) in the polyuro-polydipsic syndrome in children.
Then evaluate the discriminative capacities of the arginine stimulation test between the primary polydipsia and central insipid diabetes in the polyuro-polydipsic syndrome in children. And finally evaluate the cost-effectiveness of a new decisional algorithm for the differential diagnosis of PPS in children and evaluate the impact of infusion volume on copeptin secretion using the protidemia copeptin ratio.
Detailed description
Routine biochemical tests are performed to screen patients for PPS and determine basal copeptin level after solid fasting since midnight without water restriction: 1/ a basal copeptin value ≥ 30 pmol/L defines the diagnosis of NDI and results in a specific care; 2/ a basal copeptin < 30 pmol/L defines the group of eligible patients for arginine stimulation. The arginine-stimulated copeptin test start at 8 am, at the dose of 0.5 g/kg over 30min. Copeptin is measured at T0 (before infusion), T45, T60, T90, and T120 min after infusion.
Patients with basal copeptin value over 3.53 pmol/L are considered as positive diagnosis of PP (Se 100%, Sp 87.4%) and cerebral MRI is not performed for this group of patients (PP group).
Patients with basal copeptin value < 3.53 pmol/L are considered as an uncertain diagnosis (UD) and cerebral and pituitary MRI is performed with a least two independent interpretations. Abnormal pituitary MRI allows a diagnosis of CDI leading to etiological investigations and AVP treatment. Patients with basal copeptin ≥ 3.53 pmol/l (PP group), and UD patients with normal MRI have gradual reduction of water intake without AVP treatment. For all these latest patients, a clinical and biological reevaluation is performed one month later.
The gold standard will be the final diagnosis PP vs. CDI based on a set of indicators: medical history, physical examination, pituitary hormonal assessment, hypothalamo-pituitary MRI, follow-up at 1 month.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NDI-PP- CDI groups | Experimental | Procedure: Measure of Basal Copeptin level, Procedure: Measure of arginine-stimulated copeptin, Procedure: IRM, Behavioral: Water reduction at homeCopeptin represents a new biomarker, direct mirror of AVP release with remarkable characteristics (stable, rapid determination, small blood volume). Copeptin has become a diagnostic tool in adult PPS and eliminated WDT in the diagnostic process. In children, basal copeptin values help for NDI and to exclude CDI (basal copeptin threshold > 30 and >3.53 pmol/l (Se 100%, Sp 87.4%), respectively). Below 3.53 pmol/l, basal copeptin performance was inadequate to discriminate PP and CDI, highlighting the relevance of the stimulated copeptin study to improve this strategy. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children aged 2 to 18 years with polyuro-polydipsia syndrome (defined as hypotonic diuresis \> 50 mL/kg/day in pediatric age or 30 mL/kg/day in late puberty (Tanner 5)) presenting for differential diagnosis between PP and DIC
- Basal copeptin of less than 30 pmol/l
- Agreeing to participate in the study
- Whose two parents' consent to have their child participate in the study.
Key exclusion criteria (17 listed)
- Diabetes mellitus
- Unbalanced dysthyroidism
- Corticotropic deficiency
- Ionic disorders (dysnatremia \< 135 or \> 145 mmol/l, dyskalemia \< 3 or \> 5 mmol/l, corrected dyscalcemia \< 2.2 or \> 2.6 mmol/L)
- Moderate to severe clinical dehydration (recent weight loss \> 5% of body weight, clinical or biological signs of dehydration) requiring immediate therapeutic management
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 |
|---|---|---|
| Measure of Basal Copeptin levelCopeptin test is performed after solid fasting since midnight without water restriction. After blood collection on heparin tube used for biological inclusion criteria, heparinized plasma is transferred to Timone University hospital (transport temperature +4°C) for screening copeptin assay. The basal copeptin level determines the next step: 1. copeptin ≥ 30 pmol/L defines the diagnosis of NDI and results in a specific care; 2. copeptin \< 30 pmol/L defines the group of eligible patients for arginine stimulation | Procedure or surgery | NDI-PP- CDI groups |
| Measure of arginine-stimulated copeptinThe arginine-stimulated copeptin test start at 8 am, after solid fasting since midnight without water restriction, and 30 min of rest in decubitus position. A dose of 0.5 g/kg of arginine (maximum 40g) diluted in 0.9% NaCl is infused over 30 min through a peripheral venous line. Copeptin is measured at T0 (before infusion), T45, T60, T90, and T120 min after infusion. | Procedure or surgery | NDI-PP- CDI groups |
| IRMBased on our previous study, patients with basal copeptin value over 3.53 pmol/L are considered as positive diagnosis of PP (Se 100%, Sp 87.4%) and cerebral MRI is not performed for this group of patients (PP group). A cerebral and pituitary MRI performed according to reference procedures (without and with contrast medium used in routine care) for patients considered as an uncertain diagnosis (UD) based on basal copeptin value (\&lt; 3.53 pmol/L). MRI interpretation is performed by two independent neuroradiologists (one from the recruiting center and one from the pilot center). In case of discrepancies, a third independent interpretation will be performed by a neuroradiologist from the coordinating center. Abnormal pituitary MRI (thickened pituitary stalk pituitary tumor, ectopic neurohypophysis, septo-optic dysplasia, empty sellar, Rathke pouch) allows a diagnosis of CDI leading to etiological investigations and AVP treatment. | Procedure or surgery | NDI-PP- CDI groups |
| Water reduction at homePatients with basal copeptin ≥ 3.53 pmol/l (PP group), and UD patients with normal MRI have gradual reduction of water intake at home without AVP treatment : gradual reduction with 20% in the first week, 30% in the second, 40% in the third, reaching 50% of daily fluid in the last week including restriction overnight, deletion drink before sleep. Some recommendations will be provided to help physicians. For all these latest patients, a clinical reassessment (weight, height, heart rate, blood pressure, input/output 24 hours balance) is performed one month later. | Behavioural | NDI-PP- CDI groups |
Primary outcome
Measurement of arginine-stimulated copeptine level
Time frame: Different time points of argenine stimulates copeptine level will be measured at 45 minutes, 60 minutes, 90 minutes and 120 minutes
Determine arginine-stimulated copeptine level for each time (T45min, T60min, T90min, T120min)
2 secondary outcomes
Cost savings applying a new algorithm for the exploration of the Polyuria-polydipsia Syndrome using an Argenin-stimulated copeptin test
Time frame: Month 36
Copeptin Ratio
Time frame: Month 36
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 13 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Primary Polydipsia
Recruiting
Copeptin Measurement After Mannitol and Hypertonic Saline for the Diagnosis of Polyuria-polydipsia Syndrome
Arginine Vasopressin Deficiency, Primary Polydipsia
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.
Rawand MASOUD contact
Rachel REYNAUD, Pr principal investigator
AP-HM
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure of Basal Copeptin level, Measure of arginine-stimulated copeptin and IRM in people with Primary Polydipsia and Central Diabetes Insipidus, run by Assistance Publique Hopitaux De Marseille at 14 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 17 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: opening soon, as of the sponsor's last update on 13 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 14 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 Rachel REYNAUD (0491388040, Rachel.REYNAUD@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of arginine-stimulated copeptine level (time frame: Different time points of argenine stimulates copeptine level will be measured at 45 minutes, 60 minutes, 90 minutes and 120 minutes). 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 13 Feb 2025.