Delirium - PostoperativePhase 2PROTEXNCT06648681
Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients
A Phase 2 study testing Lemborexant 5 mg in people with Delirium - Postoperative and Cardiac Surgery, run by University of British Columbia at 1 site in Canada.
Trial summary
Post-operative delirium is a common complication following cardiac surgery and is associated with increased 1 year mortality. Currently there are no drug therapies to prevent delirium. Orexin is a neuromodulator thought to play an important role in disordered sleep, one of the instigators of delirium. Read more about this study
- Who is it for?
- Ages 61 years and older
- Conditions the study is for
- Delirium - Postoperative, Cardiac Surgery, Cardiac Surgery Subjects
- What is being tested?
- Lemborexant 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2025to 30 Apr 2027
- Phase
- Phase 2
- 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 61 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to hospital following open cardiac surgery through midline sternotomy
Who cannot join
- ● Known severe obstructive sleep apnea diagnosed by polysomnography or STOPBANG score > 5
- Periodic limb movement disorder or restless legs syndrome
- Narcolepsy
- Somnolence (Pasero Opioid Sedation Scale (POSS) >2)
- Current alcohol or substance use disorder as defined by the DSM-V
- Patient already taking moderate or strong CYP3A inhibitors
Show all 13Show fewer
- Frequent use of medications for insomnia defined as >4 days per week.
- Liver failure (Child-Pugh score B or C)
- Renal failure (eGFR<30 ml/min/1.73 m2)
- Pre-existing delirium (ICDSC score >3 or CAM/CAM-ICU positive) at time of consent
- BMI>40 kg/m2
- Known allergy or hypersensitivity to study drug
- Inability to communicate in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Trial of Lemborexant for the Prevention of Delirium After Cardiac Surgery (PROTEX): A Pilot Study
Post-operative delirium is a common complication following cardiac surgery and is associated with increased 1 year mortality. Currently there are no drug therapies to prevent delirium. Orexin is a neuromodulator thought to play an important role in disordered sleep, one of the instigators of delirium. Lembrorexant is an orexin antagonist, originally approved for sleep, that may also reduce the incidence of delirium. The Investigators propose a pilot study to determine the feasibility of a randomized controlled trial comparing Lembrorexant to placebo in patients following cardiac surgery in reducing the incidence of delirium, and improving sleep.
Read the detailed description
Purpose:
This is a pilot study to determine the feasibility of a larger randomized controlled trial comparing lemborexant to placebo in patients following cardiac surgery. The primary outcome of this feasibility study is to determine the rate of enrolment, adherence and retention of patients. Secondary outcomes will include incidence of postoperative delirium, delirium days, quality of sleep, hospital length of stay, and the safety and adverse side effect profile of Lemborexant.
Hypothesis:
- Primary outcome: It is feasible to perform a study of lembrorexant versus placebo in patients after cardiac surgery, as defined by achieving a recruitment rate of at least 70% and adherence rate of 80% to the study protocol and drug administration schedule.
Justification:
Postoperative delirium is a frequent complication after cardiac surgery, with an incidence estimated at 20-52%. It is associated with increased 1 year mortality, longer ICU and hospital length of stay, and declines in functional and cognitive status that may persist for up to one year. Orexin, a neuromodulator regulating sleep and wakefulness, is believed to significantly influence the pathophysiology of delirium through its association with disordered sleep. Thus far, there are no promising therapies in prevention or treatment of post cardiac surgery delirium.
Lemborexant is a novel orexin antagonist that has been approved for treating insomnia, and has shown promising results in some studies in reducing incidence of delirium post-cardiac surgery. However, the generalizability of these studies is limited by small numbers of patients, an exclusively Asian population, variability in clinical settings, use of different clinical delirium assessment tools, and variability in comparator groups. In addition, the safety profile of lembrorexant has not been well established in the cardiac surgery population.
Objectives:
Primary Objective: to determine the rate of enrolment, adherence and retention of patients in a randomized controlled trial comparing Lemborexant to placebo early after cardiac surgery.
Secondary Objective: to compare the incidence of postoperative delirium, quality of sleep as measured by Richard Campbell's Sleep Questionnaire (RCSQ), delirium days, hospital length of stay between Lembrorexant and placebo. To determine the safety and adverse side effect profile of Lemborexant.
Research Design:
This will be a single centre, randomized, double blinded, placebo-controlled pilot trial, with 1:1 allocation of study drug to placebo. Local enrollment local is 60 patients (30 control, 30 experimental).
Statistical Analysis plan:
Patient characteristics will be described using means and standard deviations for continuous data and proportions (%) for categorical data. All analyses will be conducted on the intention-to-treat population. For the primary feasibility outcomes, the investigators will calculate 95% confidence intervals using the whole trial sample. For the secondary outcomes, the investigators will compare proportions with Lembrorexant vs placebo two-sample t-test for parametric data and Wilcoxon Rank Sum test for non parametric data. Analyses will be conducted using R 4.0.5.
Sample Size Calculation: To assess feasibility outcomes, the sample size was calculated to estimate an adherence rate of 80% with a 95% confidence interval of +/- 10%. From this calculation, the sample size will be set at 60 participants, or 10% of the sample size of a definitive trial.
- Conditions
- Delirium - Postoperative, Cardiac Surgery, Cardiac Surgery Subjects, Orexin Antagonist, Feasibility Studies, Sleep
- Being tested
- Lemborexant 5 mg, Control (placebo) group
- Keywords
- lemborexant, Postoperative Delirium, sleep medication, ICDSC, CAM, cardiac surgery, sleep aid, open heart surgery, delirium, sleep quality, Richards-Campbell Sleep Questionnaire
- Medical subject headings
- Emergence Delirium, Delirium, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemborexant 5 mgDrug
The intervention is the oral administration of a study drug containing lemborexant 5 mg daily between 2000h and 0000h for the first 7 days following extubating/initiation criteria is met or until their hospital discharge or until the first diagnosis of delirium, whichever occurs first.
Initiation criteria:
- The participant has been extubated for at least 2 hours II. all other sedative medications have been discontinued for >1 hour III. the participant has a Richmond Agitation and Sedation Scale (RASS) score of >-1 or a Pasero Opioid-induced Sedation Scale (POSS) score <3.
If satisfactory sleep is not achieved with the 5 mg dose of the study drug, as defined by a Richards Campbell Sleep Score <50 within 1 hour, another insomnia medication may be administered on participant request and clinician judgement.
If participants develop delirium, the study drug will be discontinued.
Control (placebo) groupDrug
The control group will receive an oral placebo tablet daily between 2000h and 0000h for the first 7 days following when initiation criteria is met or until their hospital discharge, whichever occurs first.
Initiation criteria:
- The participant has been extubated for at least 2 hours II. all other sedative medications have been discontinued for >1 hour III. the participant has a Richmond Agitation and Sedation Scale (RASS) score of >-1 or a Pasero Opioid-induced Sedation Scale (POSS) score <3.
If satisfactory sleep is not achieved with the 5 mg dose of the study drug, as defined by a Richards Campbell Sleep Score <50 within 1 hour, another insomnia medication may be administered on participant request and clinician judgement.
If participants develop delirium, the study drug will be discontinued.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention arm will receive the study drug, Lemborexant 5mg, daily for 7 days post-operatively while in hospital. Receives: Drug: Lemborexant 5 mg |
| Control | Placebo comparator | The Control arm will receive the placebo study drug daily for 7 days post-operatively while in hospital. Receives: Drug: Control (placebo) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
Recruitment will be deemed feasible if the investigators are able to achieve a minimum recruitment rate of 2 patients per week, with 80% of eligible patients approached consenting to participate.
Measured: Prior to Surgery, for the duration of the study recruitment period, estimated to be approximately 2 years
Data Collection Adherence
Data collection adherence will be defined as 80% completion of delirium screening and sleep scores
Measured: Post-operative day 0 to 7
Secondary outcomes (7)
Incidence of Postoperative Delirium
Delirium will be assessed using the screening tools ICDSC (ICU Delirium Screening Checklist) while the patient is in the Cardiac Surgery Intensive Care Unit (CSICU) and CAM (Confusion Assessment Method) when the patient is on the hospital ward. The ICDSC is an 8-item delirium screening instrument (range: 0-8 points) that evaluates a patient's level of consciousness, inattention, disorientation, hallucinations or delusions, psychomotor activity, inappropriate speech or mood, sleep disturbance and fluctuation of symptoms. The CAM is a tool that assesses for the four features of delirium: Feature 1 is an acute change in mental status or a fluctuating mental status, Feature 2, is inattention, Feature 3, is altered level of consciousness and Feature 4, is disorganized thinking. Assessors rate each feature as present or not present based on guiding questions.
Measured: Post-operative day 0 at baseline (immediately before administration of the drug/placebo) and every 12 hours following drug/placebo administration until end of the 7 day follow-up
Delirium Days
The number of days where delirium was present in the post-operative study period. Postoperative delirium is defined by either: ICU Delirium Screening Checklist (ICDSC) score >3 in the cardiac surgical ICU (CSICU) or a positive Confusion Assessment Method (CAM) score on the postoperative surgical ward. The ICDSC is an 8-item delirium screening instrument (range: 0-8 points) that evaluates a patient's level of consciousness, inattention, disorientation, hallucinations or delusions, psychomotor activity, inappropriate speech or mood, sleep disturbance and fluctuation of symptoms. The CAM is a tool that assesses for the four features of delirium: Feature 1 is an acute change in mental status or a fluctuating mental status, Feature 2, is inattention, Feature 3, is altered level of consciousness and Feature 4, is disorganized thinking. Assessors rate each feature as present or not present based on guiding questions.
Measured: Post-operative day 0 to 7
Adverse side effects
Adverse side effects other than delirium, including daytime somnolence. Daytime somnolence will be assessed by the Pasero Opioid-Induced Sedation Scale (POSS). For every instance of a study drug discontinuation, a form will be completed documenting the clinical reasons for discontinuation.
Measured: At the time of study drug initiation (T0) and daily following drug/placebo administration (T1 onwards) until end of the 7 day study follow-up.
Sleep Quality
Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ) which is a validated instrument to assess sleep quality in critically ill patients. It evaluates perceptions of sleep depth, sleep latency, number of awakenings, time spent awake, and overall sleep quality. There are 5 questions with a 100 point Visual Analogue Scale with 100 being the best outcome and 0 being the worst. For example, the participant is asked to rate their sleep depth, "My sleep last night was a:" from 0 (light sleep), to 100 (deep sleep). This questionnaire will be administered by a trained member of the research team daily for the duration of administration of the study drug. The score is reported as the mean of the 5 questions.
Measured: Preoperative baseline (time of recruitment/consent T -1), and daily following drug/placebo administration (T1 onwards) until end of the 7 day follow-up.
Incidence of Additional Sleep Medications
Incidence of participants requiring additional sleep medications.
Measured: Post-operative day 0 to 7
Postoperative Hospital Length of Stay
Number of days a patient is in hospital postoperatively.
Measured: Postoperative day 0 until hospital discharge, usually about 5-7 days postoperatively
In-Hospital Mortality
Incidence of mortality while in hospital for their index surgery
Measured: from postoperative day 0 to hospital discharge, usually 5-7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 May 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single centre, randomized, double blinded, placebo-controlled pilot trial, with 1:1 allocation of study drug to placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc., Providence Health Care, British Columbia, St. Paul's Hospital, Vancouver (Providence Health Care)
- Responsible party
- Principal investigator, Ron Ree, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648681
- Sponsor's protocol ID
- H24-00546
- Other IDs
- NOL 290159, NOL 294580
- Acronym
- PROTEX
- Status last verified
- Apr 2025
- First submitted
- 12 Oct 2024
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Lemborexant for the Prevention of Delirium After Cardiac Surgery (PROTEX): A Pilot Study
- ClinicalTrials.gov ID
- NCT06648681
- Acronym / sponsor ID
- PROTEX / H24-00546
- Conditions
- Delirium - Postoperative, Cardiac Surgery, Cardiac Surgery Subjects, Orexin Antagonist, Feasibility Studies, Sleep
- Keywords
- lemborexant, Postoperative Delirium, sleep medication, ICDSC, CAM, cardiac surgery, sleep aid, open heart surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Eisai Inc., Providence Health Care, British Columbia, St. Paul's Hospital, Vancouver (Providence Health Care)
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 Oct 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.
Post-operative delirium is a common complication following cardiac surgery and is associated with increased 1 year mortality. Currently there are no drug therapies to prevent delirium. Orexin is a neuromodulator thought to play an important role in disordered sleep, one of the instigators of delirium. Lembrorexant is an orexin antagonist, originally approved for sleep, that may also reduce the incidence of delirium. The Investigators propose a pilot study to determine the feasibility of a randomized controlled trial comparing Lembrorexant to placebo in patients following cardiac surgery in reducing the incidence of delirium, and improving sleep.
Detailed description
Purpose:
This is a pilot study to determine the feasibility of a larger randomized controlled trial comparing lemborexant to placebo in patients following cardiac surgery. The primary outcome of this feasibility study is to determine the rate of enrolment, adherence and retention of patients. Secondary outcomes will include incidence of postoperative delirium, delirium days, quality of sleep, hospital length of stay, and the safety and adverse side effect profile of Lemborexant.
Hypothesis:
- Primary outcome: It is feasible to perform a study of lembrorexant versus placebo in patients after cardiac surgery, as defined by achieving a recruitment rate of at least 70% and adherence rate of 80% to the study protocol and drug administration schedule.
Justification:
Postoperative delirium is a frequent complication after cardiac surgery, with an incidence estimated at 20-52%. It is associated with increased 1 year mortality, longer ICU and hospital length of stay, and declines in functional and cognitive status that may persist for up to one year. Orexin, a neuromodulator regulating sleep and wakefulness, is believed to significantly influence the pathophysiology of delirium through its association with disordered sleep. Thus far, there are no promising therapies in prevention or treatment of post cardiac surgery delirium.
Lemborexant is a novel orexin antagonist that has been approved for treating insomnia, and has shown promising results in some studies in reducing incidence of delirium post-cardiac surgery. However, the generalizability of these studies is limited by small numbers of patients, an exclusively Asian population, variability in clinical settings, use of different clinical delirium assessment tools, and variability in comparator groups. In addition, the safety profile of lembrorexant has not been well established in the cardiac surgery population.
Objectives:
Primary Objective: to determine the rate of enrolment, adherence and retention of patients in a randomized controlled trial comparing Lemborexant to placebo early after cardiac surgery.
Secondary Objective: to compare the incidence of postoperative delirium, quality of sleep as measured by Richard Campbell's Sleep Questionnaire (RCSQ), delirium days, hospital length of stay between Lembrorexant and placebo. To determine the safety and adverse side effect profile of Lemborexant.
Research Design:
This will be a single centre, randomized, double blinded, placebo-controlled pilot trial, with 1:1 allocation of study drug to placebo. Local enrollment local is 60 patients (30 control, 30 experimental).
Statistical Analysis plan:
Patient characteristics will be described using means and standard deviations for continuous data and proportions (%) for categorical data. All analyses will be conducted on the intention-to-treat population. For the primary feasibility outcomes, the investigators will calculate 95% confidence intervals using the whole trial sample. For the secondary outcomes, the investigators will compare proportions with Lembrorexant vs placebo two-sample t-test for parametric data and Wilcoxon Rank Sum test for non parametric data. Analyses will be conducted using R 4.0.5.
Sample Size Calculation: To assess feasibility outcomes, the sample size was calculated to estimate an adherence rate of 80% with a 95% confidence interval of +/- 10%. From this calculation, the sample size will be set at 60 participants, or 10% of the sample size of a definitive trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single centre, randomized, double blinded, placebo-controlled pilot trial, with 1:1 allocation of study drug to placebo.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Lemborexant 5 mgThe intervention arm will receive the study drug, Lemborexant 5mg, daily for 7 days post-operatively while in hospital. |
| Control | Placebo comparator | Drug: Control (placebo) groupThe Control arm will receive the placebo study drug daily for 7 days post-operatively while in hospital. |
Who may qualify
- Ages
- 61 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admitted to hospital following open cardiac surgery through midline sternotomy
Key exclusion criteria (13 listed)
- ● Known severe obstructive sleep apnea diagnosed by polysomnography or STOPBANG score > 5
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 |
|---|---|---|
| Lemborexant 5 mgThe intervention is the oral administration of a study drug containing lemborexant 5 mg daily between 2000h and 0000h for the first 7 days following extubating/initiation criteria is met or until their hospital discharge or until the first diagnosis of delirium, whichever occurs first. Initiation criteria: I. The participant has been extubated for at least 2 hours II. all other sedative medications have been discontinued for >1 hour III. the participant has a Richmond Agitation and Sedation Scale (RASS) score of >-1 or a Pasero Opioid-induced Sedation Scale (POSS) score <3. If satisfactory sleep is not achieved with the 5 mg dose of the study drug, as defined by a Richards Campbell Sleep Score <50 within 1 hour, another insomnia medication may be administered on participant request and clinician judgement. If participants develop delirium, the study drug will be discontinued. | Drug | Intervention |
| Control (placebo) groupThe control group will receive an oral placebo tablet daily between 2000h and 0000h for the first 7 days following when initiation criteria is met or until their hospital discharge, whichever occurs first. Initiation criteria: I. The participant has been extubated for at least 2 hours II. all other sedative medications have been discontinued for >1 hour III. the participant has a Richmond Agitation and Sedation Scale (RASS) score of >-1 or a Pasero Opioid-induced Sedation Scale (POSS) score <3. If satisfactory sleep is not achieved with the 5 mg dose of the study drug, as defined by a Richards Campbell Sleep Score <50 within 1 hour, another insomnia medication may be administered on participant request and clinician judgement. If participants develop delirium, the study drug will be discontinued. | Drug | Control |
Primary outcome
Recruitment Feasibility
Time frame: Prior to Surgery, for the duration of the study recruitment period, estimated to be approximately 2 years
Recruitment will be deemed feasible if the investigators are able to achieve a minimum recruitment rate of 2 patients per week, with 80% of eligible patients approached consenting to participate.
Data Collection Adherence
Time frame: Post-operative day 0 to 7
Data collection adherence will be defined as 80% completion of delirium screening and sleep scores
7 secondary outcomes
Incidence of Postoperative Delirium
Time frame: Post-operative day 0 at baseline (immediately before administration of the drug/placebo) and every 12 hours following drug/placebo administration until end of the 7 day follow-up
Delirium Days
Time frame: Post-operative day 0 to 7
Adverse side effects
Time frame: At the time of study drug initiation (T0) and daily following drug/placebo administration (T1 onwards) until end of the 7 day study follow-up.
Sleep Quality
Time frame: Preoperative baseline (time of recruitment/consent T -1), and daily following drug/placebo administration (T1 onwards) until end of the 7 day follow-up.
Incidence of Additional Sleep Medications
Time frame: Post-operative day 0 to 7
Postoperative Hospital Length of Stay
Time frame: Postoperative day 0 until hospital discharge, usually about 5-7 days postoperatively
In-Hospital Mortality
Time frame: from postoperative day 0 to hospital discharge, usually 5-7 days postoperatively
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 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lemborexant 5 mg in people with Delirium - Postoperative and Cardiac Surgery, run by University of British Columbia at 1 site in Canada.
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 1 inclusion and 13 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 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ron Ree, MD (604-561-8348, ronmree@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: Prior to Surgery, for the duration of the study recruitment period, estimated to be approximately 2 years). The study lists 2 primary outcomes in all. 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 Apr 2025.