Acute PainPhase 4ESKAPENCT06853041
ESKetamine Low-dose vs Ketamine Low-dose for Severe Acute Pain in Emergency Units, Comparison of PsychodyslEptic Effects
A Phase 4 study testing Esketamine and Ketamine in people with Acute Pain, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Almost 30% of painful patients in emergency departments (ED) describe their pain as severe (i.e. a Verbal Numerical Rating Score VNRS ≥ 6 on a scale ranging from 0 to 10). The management of such severe pain needs to be rapid and safe, and for this purpose intravenous (IV) morphine titration is still the gold-standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Esketamine and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2025to 5 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 or over,
- consulting our emergency department for a medical or traumatic pathology responsible for acute (less than 7 days old) and severe pain (greater than or equal to 6 on the Verbal Numerical Rating Scale, which has 11 levels from 0 = no pain to 10 = maximum imaginable pain).
- Free and informed consent given before the start of the trial.
- Patients affiliated to social security system.
Who cannot join
- Inability to quantify pain score ;
- proven or suspected intoxication (drug or alcohol) leading to consciousness disorders (Glasgow score less than or equal to 15) ;
- person under legal protection or deprived of liberty ;
- pregnant or breast-feeding patients ;
- known allergy to ketamine or esketamine ;
- history of drug addiction or dependence ;
Show all 14Show fewer
- insufficiently controlled hyperthyroidism ;
- history of cerebral of myocardial infarction ;
- known severe heart failure ;
- existence of intracranial hypertension, glaucoma or ocular trauma ;
- unstable vital signs (systolic blood pressure < 90 mmHg or > 180, heart rate < 50 per minute or > 150, respiratory rate < 10 per minute or > 30) ;
- chronic treatment with aminophylline, theophylline or methylergometrine ;
- administration of morphine or another opioid within one hour of inclusion ;
- ongoing simultaneous participation in another study that could interfere with the treatment studied or the results of statistical analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude randomisée contrôlée en Double-aveugle ESKAPE : ESKétamine Low-dose Versus kétamine Low-dose Pour la Douleur Aiguë sévère Aux Urgences, Comparaison Des Effets PsychodyslEptiques
Almost 30% of painful patients in emergency departments (ED) describe their pain as severe (i.e. a Verbal Numerical Rating Score VNRS ≥ 6 on a scale ranging from 0 to 10). The management of such severe pain needs to be rapid and safe, and for this purpose intravenous (IV) morphine titration is still the gold-standard. However, morphine titration takes up considerable caregiver time, as patients need to be monitored and treated progressively with small quantities of morphine every 5 minutes until analgesia. This is sometimes difficult to reconcile with a saturating flow of patients, and overcrowding in ED is proven to significantly delay time-to-analgesia, and even lead to deleterious under-treatment. Finally, the opioid crisis is a major concern, explaining why strategies are being advocated to develop other ways of managing severe acute pain in the ED and to limit the use of opioids.
Recent studies show that ketamine administered in small IV doses ("low-dose" ketamine LDK: 0.2 to 0.3 mg/kg) possesses potent analgesic activity as well as interesting anti-hyperalgesic and anti-allodynic properties. Compared with morphine, LDK does not induce respiratory depression, but can sometimes induce disturbing psychodysleptic effects. These may include a sensation of unreality, fatigue, anxiety, dizziness or hallucinations. According to studies, 30-80% of LDK-treated patients experience psychodysleptic effects. However, two recent studies suggest that slow IV injections of LDK (over 10 minutes) may improve patient tolerance, although these slow infusions do not totally reduce this discomfort.
Pharmacologically, ketamine is a racemic mixture of 2 isomers: esketamine S(+), which is dextrorotatory, and arketamine R(-), which is levorotatory. In recent years, a new formulation containing only esketamine has been made available to hospitals in some northern European countries, and more recently in France. Esketamine appears to have twice the analgesic efficacy of racemic ketamine, and studies on healthy volunteers or in peri-operative settings suggest that it is also better tolerated psychologically than ketamine. For the moment, however, scientific data are lacking, and no comparative trial has yet been conducted in the ED setting. The investigators plan to conduct in their ED a prospective, single-center, randomized, double-blind study aiming to compare the tolerance and efficacy of esketamine versus racemic LDK in patients presenting with severe acute pain (VNRS ≥ 6/10).
Read the detailed description
More than two-thirds of patients visiting emergency departments (ED) complain of acute pain, and of these, almost 30% describe their pain as severe (i.e. a Verbal Numerical Rating Score VNRS ≥ 6 on a scale ranging from 0 to 10). The management of such severe pain needs to be rapid, safe and adapted to the suspected underlying causative pathology. To achieve this, recommendations call for widespread use of intravenous (IV) morphine titration, which combines high analgesic efficacy with a good clinical safety profile (low risk of respiratory depression). However, the need to monitor patients and inject small quantities of morphine every 5 minutes until the patient is relieved takes up a considerable amount of caregiver time, which is sometimes difficult to reconcile with a saturating flow of patients. This growing problem of overcrowding in ED can lead to significant under-treatment and delays in analgesia. At the same time, the opioid crisis in the USA is beginning to affect other countries, which explains why certain strategies are being advocated to limit the use of opioids, and why researchers are attempting to develop other ways of managing severe acute pain in the ED. Recent studies show that ketamine administered in small IV doses ("low-dose" ketamine KLD: 0.2 to 0.3 mg/kg) possesses potent analgesic activity comparable to that of IV morphine. These analgesic qualities have been known for decades, and ketamine's unique non-competitive antagonism of the NMDA (N-methyl-D-aspartic) receptor also results in interesting anti-hyperalgesic and anti-allodynic properties. Compared with morphine, KLD does not induce the risk of respiratory depression, but can induce psychodysleptic effects that can sometimes be troublesome. These may include a sensation of unreality, fatigue, anxiety, dizziness or hallucinations. According to studies, 30 to 80% of patients treated with KLD experience a psychodysleptic effect. However, two recent studies suggest that slow IV injections of KLD (>10 min) may improve patient tolerance, although this slow injection may not significantly reduce this discomfort. Pharmacologically, ketamine is a racemic mixture of 2 isomers: esketamine S(+), which is dextrorotatory, and arketamine R(-), which is laevorotatory. In recent years, a new formulation containing only esketamine has been made available to hospitals in some northern European countries, and more recently in France. Esketamine appears to have twice the analgesic efficacy of racemic ketamine, and studies on healthy volunteers or in peri-operative settings suggest that it is also better tolerated psychologically than ketamine. For the moment, however, scientific data are lacking, and to our knowledge no comparative trial has yet been conducted in the ED setting. The prospective, single-center, randomized, double-blind study the investigators plan to conduct in the ED will compare the tolerance and efficacy of esketamine versus racemic LDK in patients presenting with severe acute pain (VNRS ≥ 6/10).
- Conditions
- Acute Pain
- Being tested
- Esketamine, Ketamine
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
A single slow intravenous injection of low-dose esketamine (0.15 mg/kg) over 10 minutes using an infusion pump.
KetamineDrug
A single slow intravenous injection of low-dose ketamine (0,3 mg/kg) with an infusion pump, during 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| low-dose esketamine | Experimental | Not described Receives: Drug: Esketamine |
| low-dose ketamine | Active comparator | Not described Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients experiencing at least one psychodysleptic effect of the SERSDA (Side Effects Rating Scale for Dissociate Anesthetics) scale.
The primary endpoint will be the proportion of patients experiencing at least one psychodysleptic effect, in the control group (ketamine IV 0.3 mg/kg) and in the active group (esketamine IV 0.15 mg/kg). Using the SERSDA (Side Effects Rating Scale for Dissociate Anesthetics) scale, the most widely used in studies, which comprises 9 items: fatigue, headache, dizziness, feeling of unreality, generalized feeling of discomfort, hearing changes, vision changes, mood change, hallucination.
Measured: The time of initiation of the ketamine or esketamine infusion defines the minute 0 time point of the study. The presence of any of these 9 SERSDA items will be assessed by patients every 5 minutes from minute 0 to minute 0 + 60 minutes.
Secondary outcomes (5)
Intensity of the psychodysleptic effects described by patients.
For this secondary outcome, the 4 intensity items of the SERSDA (Side Effects Rating Scale for Dissociative Anesthetics) will be used : 1 = weak effect, 2 = moderate effect, 3 = troublesome effect and 4 = very troublesome effect.
Measured: The time of initiation of the ketamine or esketamine infusion defines the minute 0 time point of the study. The intensity of the psychodysleptic effects will be assessed by patients every 5 minutes from minute 0 to minute 0 + 60 minutes.
Analgesic efficacy of the 2 molecules (ketamine or esketamine)
- evolution of the Verbal Numercial Rating Score VNRS (scale from 0 "no pain" to 10 = "worst pain imainalbe") as a function of time 2. proportion of patients reporting pain relief (Verbal Numerical Rating Score VNRS ≤ 3/10) 3. proportion of patients needing additional analgesia ("rescue analgesia") which will be at the discretion of the physicians
Measured: The time of initiation of the ketamine or esketamine infusion defines the minute 0 time point of the study. The intensity of the psychodysleptic effects will be assessed by patients every 5 minutes from minute 0 to minute 0 + 60 minutes.
Any other hemodynamic and respiratory adverse event
Measurement of patient's vital signs: blood pressure with a portable monitor every 15 minutes from t0 to t0 + 60 min
Measured: The time of initiation of the ketamine or esketamine infusion defines the minute 0 time point of the study. The intensity of the psychodysleptic effects will be assessed by patients every 5 minutes from minute 0 to minute 0 + 60 minutes.
Any other hemodynamic and respiratory adverse event
Measurement of patient's vital signs : heart rate with a portable monitor every 15 minutes from t0 to t0 + 60 min
Measured: The time of initiation of the ketamine or esketamine infusion defines the minute 0 time point of the study. The intensity of the psychodysleptic effects will be assessed by patients every 5 minutes from minute 0 to minute 0 + 60 minutes.
Any other hemodynamic and respiratory adverse event
Measurement of patient's vital signs : pulsed oxygen saturation with a portable monitor every 15 minutes from t0 to t0 + 60 min
Measured: The time of initiation of the ketamine or esketamine infusion defines the minute 0 time point of the study. The intensity of the psychodysleptic effects will be assessed by patients every 5 minutes from minute 0 to minute 0 + 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start6 May 2025
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853041
- Sponsor's protocol ID
- 24-PP-09
- Acronym
- ESKAPE
- Status last verified
- May 2026
- First submitted
- 6 Feb 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude randomisée contrôlée en Double-aveugle ESKAPE : ESKétamine Low-dose Versus kétamine Low-dose Pour la Douleur Aiguë sévère Aux Urgences, Comparaison Des Effets PsychodyslEptiques
- ClinicalTrials.gov ID
- NCT06853041
- Acronym / sponsor ID
- ESKAPE / 24-PP-09
- Conditions
- Acute Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 28 Feb 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.
Almost 30% of painful patients in emergency departments (ED) describe their pain as severe (i.e. a Verbal Numerical Rating Score VNRS ≥ 6 on a scale ranging from 0 to 10). The management of such severe pain needs to be rapid and safe, and for this purpose intravenous (IV) morphine titration is still the gold-standard. However, morphine titration takes up considerable caregiver time, as patients need to be monitored and treated progressively with small quantities of morphine every 5 minutes until analgesia. This is sometimes difficult to reconcile with a saturating flow of patients, and overcrowding in ED is proven to significantly delay time-to-analgesia, and even lead to deleterious under-treatment. Finally, the opioid crisis is a major concern, explaining why strategies are being advocated to develop other ways of managing severe acute pain in the ED and to limit the use of opioids.
Recent studies show that ketamine administered in small IV doses ("low-dose" ketamine LDK: 0.2 to 0.3 mg/kg) possesses potent analgesic activity as well as interesting anti-hyperalgesic and anti-allodynic properties. Compared with morphine, LDK does not induce respiratory depression, but can sometimes induce disturbing psychodysleptic effects. These may include a sensation of unreality, fatigue, anxiety, dizziness or hallucinations. According to studies, 30-80% of LDK-treated patients experience psychodysleptic effects. However, two recent studies suggest that slow IV injections of LDK (over 10 minutes) may improve patient tolerance, although these slow infusions do not totally reduce this discomfort.
Pharmacologically, ketamine is a racemic mixture of 2 isomers: esketamine S(+), which is dextrorotatory, and arketamine R(-), which is levorotatory. In recent years, a new formulation containing only esketamine has been made available to hospitals in some northern European countries, and more recently in France. Esketamine appears to have twice the analgesic efficacy of racemic ketamine, and studies on healthy volunteers or in peri-operative settings suggest that it is also better tolerated psychologically than ketamine. For the moment, however, scientific data are lacking, and no comparative trial has yet been conducted in the ED setting. The investigators plan to conduct in their ED a prospective, single-center, randomized, double-blind study aiming to compare the tolerance and efficacy of esketamine versus racemic LDK in patients presenting with severe acute pain (VNRS ≥ 6/10).
Detailed description
More than two-thirds of patients visiting emergency departments (ED) complain of acute pain, and of these, almost 30% describe their pain as severe (i.e. a Verbal Numerical Rating Score VNRS ≥ 6 on a scale ranging from 0 to 10). The management of such severe pain needs to be rapid, safe and adapted to the suspected underlying causative pathology. To achieve this, recommendations call for widespread use of intravenous (IV) morphine titration, which combines high analgesic efficacy with a good clinical safety profile (low risk of respiratory depression). However, the need to monitor patients and inject small quantities of morphine every 5 minutes until the patient is relieved takes up a considerable amount of caregiver time, which is sometimes difficult to reconcile with a saturating flow of patients. This growing problem of overcrowding in ED can lead to significant under-treatment and delays in analgesia. At the same time, the opioid crisis in the USA is beginning to affect other countries, which explains why certain strategies are being advocated to limit the use of opioids, and why researchers are attempting to develop other ways of managing severe acute pain in the ED. Recent studies show that ketamine administered in small IV doses ("low-dose" ketamine KLD: 0.2 to 0.3 mg/kg) possesses potent analgesic activity comparable to that of IV morphine. These analgesic qualities have been known for decades, and ketamine's unique non-competitive antagonism of the NMDA (N-methyl-D-aspartic) receptor also results in interesting anti-hyperalgesic and anti-allodynic properties. Compared with morphine, KLD does not induce the risk of respiratory depression, but can induce psychodysleptic effects that can sometimes be troublesome. These may include a sensation of unreality, fatigue, anxiety, dizziness or hallucinations. According to studies, 30 to 80% of patients treated with KLD experience a psychodysleptic effect. However, two recent studies suggest that slow IV injections of KLD (>10 min) may improve patient tolerance, although this slow injection may not significantly reduce this discomfort. Pharmacologically, ketamine is a racemic mixture of 2 isomers: esketamine S(+), which is dextrorotatory, and arketamine R(-), which is laevorotatory. In recent years, a new formulation containing only esketamine has been made available to hospitals in some northern European countries, and more recently in France. Esketamine appears to have twice the analgesic efficacy of racemic ketamine, and studies on healthy volunteers or in peri-operative settings suggest that it is also better tolerated psychologically than ketamine. For the moment, however, scientific data are lacking, and to our knowledge no comparative trial has yet been conducted in the ED setting. The prospective, single-center, randomized, double-blind study the investigators plan to conduct in the ED will compare the tolerance and efficacy of esketamine versus racemic LDK in patients presenting with severe acute pain (VNRS ≥ 6/10).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-dose esketamine | Experimental | Drug: Esketamine |
| low-dose ketamine | Active comparator | Drug: Ketamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18 or over,
- consulting our emergency department for a medical or traumatic pathology responsible for acute (less than 7 days old) and severe pain (greater than or equal to 6 on the Verbal Numerical Rating Scale, which has 11 levels from 0 = no pain to 10 = maximum imaginable pain).
- Free and informed consent given before the start of the trial.
- Patients affiliated to social security system.
Key exclusion criteria (14 listed)
- Inability to quantify pain score ;
- proven or suspected intoxication (drug or alcohol) leading to consciousness disorders (Glasgow score less than or equal to 15) ;
- person under legal protection or deprived of liberty ;
- pregnant or breast-feeding patients ;
- known allergy to ketamine or esketamine ;
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 |
|---|---|---|
| EsketamineA single slow intravenous injection of low-dose esketamine (0.15 mg/kg) over 10 minutes using an infusion pump. | Drug | low-dose esketamine |
| KetamineA single slow intravenous injection of low-dose ketamine (0,3 mg/kg) with an infusion pump, during 10 minutes | Drug | low-dose ketamine |
Primary outcome
Proportion of patients experiencing at least one psychodysleptic effect of the SERSDA (Side Effects Rating Scale for Dissociate Anesthetics) scale.
Time frame: The time of initiation of the ketamine or esketamine infusion defines the minute 0 time point of the study. The presence of any of these 9 SERSDA items will be assessed by patients every 5 minutes from minute 0 to minute 0 + 60 minutes.
The primary endpoint will be the proportion of patients experiencing at least one psychodysleptic effect, in the control group (ketamine IV 0.3 mg/kg) and in the active group (esketamine IV 0.15 mg/kg). Using the SERSDA (Side Effects Rating Scale for Dissociate Anesthetics) scale, the most widely used in studies, which comprises 9 items: fatigue, headache, dizziness, feeling of unreality, generalized feeling of discomfort, hearing changes, vision changes, mood change, hallucination.
5 secondary outcomes
Intensity of the psychodysleptic effects described by patients.
Time frame: The time of initiation of the ketamine or esketamine infusion defines the minute 0 time point of the study. The intensity of the psychodysleptic effects will be assessed by patients every 5 minutes from minute 0 to minute 0 + 60 minutes.
Analgesic efficacy of the 2 molecules (ketamine or esketamine)
Time frame: The time of initiation of the ketamine or esketamine infusion defines the minute 0 time point of the study. The intensity of the psychodysleptic effects will be assessed by patients every 5 minutes from minute 0 to minute 0 + 60 minutes.
Any other hemodynamic and respiratory adverse event
Time frame: The time of initiation of the ketamine or esketamine infusion defines the minute 0 time point of the study. The intensity of the psychodysleptic effects will be assessed by patients every 5 minutes from minute 0 to minute 0 + 60 minutes.
Any other hemodynamic and respiratory adverse event
Time frame: The time of initiation of the ketamine or esketamine infusion defines the minute 0 time point of the study. The intensity of the psychodysleptic effects will be assessed by patients every 5 minutes from minute 0 to minute 0 + 60 minutes.
Any other hemodynamic and respiratory adverse event
Time frame: The time of initiation of the ketamine or esketamine infusion defines the minute 0 time point of the study. The intensity of the psychodysleptic effects will be assessed by patients every 5 minutes from minute 0 to minute 0 + 60 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esketamine and Ketamine in people with Acute Pain, run by Centre Hospitalier Universitaire de Nice 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 4 inclusion and 14 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: finished, as of the sponsor's last update on 14 May 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients experiencing at least one psychodysleptic effect of the SERSDA (Side Effects Rating Scale for Dissociate Anesthetics) scale. (time frame: The time of initiation of the ketamine or esketamine infusion defines the minute 0 time point of the study. The presence of any of these 9 SERSDA items will be assessed by patients every 5 minutes from minute 0 to minute 0 + 60 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 14 May 2026.