Moderate-to-Severe Traumatic Brain InjuryICP-TBINCT07678216
Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury
A study testing propofol, midazolam and Dexmedetomidine in people with Moderate-to-Severe Traumatic Brain Injury, run by Aswan University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the effects of propofol, midazolam, and dexmedetomidine on intracranial pressure control and clinical outcomes in adults with moderate-to-severe traumatic brain injury undergoing urgent neurosurgical intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate-to-Severe Traumatic Brain Injury
- What is being tested?
- propofol, midazolam and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Moderate to severe traumatic brain injury with post-resuscitation Glasgow Coma Scale (GCS) ≤12
- Undergone urgent neurosurgical intervention (craniotomy, craniectomy, or ICP monitor placement) within 24 hours of injury
- Admitted to ICU and expected to require continuous sedation
- Hemodynamically stable or stabilized (defined as MAP ≥65 mmHg with vasopressor requirement ≤0.1 mcg/kg/min norepinephrine equivalent)
- Informed consent obtained from legally authorized representative
Who cannot join
- The Relative refusal to participate in the research.
- Known allergy or contraindication to propofol, midazolam, or dexmedetomidine
- Pre-existing neurological disorders (epilepsy, prior stroke, brain tumors, dementia) that may interfere with outcome assessment
- Severe hepatic dysfunction (Child-Pugh Class C) or acute liver failure
- Severe renal dysfunction (eGFR <30 mL/min/1.73m² or requiring renal replacement therapy)
- Pregnancy or breastfeeding
Show all 11Show fewer
- Hemodynamic instability requiring norepinephrine >0.1 mcg/kg/min or equivalent vasopressor support
- Heart rate <50 bpm or second/third-degree AV block without pacemaker (relative contraindication for dexmedetomidine)
- Clinical determination of brain death or expected survival <24 hours
- Enrollment in another interventional trial
- Severe polytrauma requiring ongoing surgical interventions that would interfere with protocol adherence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Aswan University Hospital
Asyut, Asyut Governorate, 81528
Mohamed Abdelhamed, M.Sc., 01061651065, hamedo_2020@yahoo.com
About this study
Official title: Effect of Propofol, Midazolam, and Dexmedetomidine on Intracranial Pressure and Clinical Outcomes in Patients With Moderate-to-Severe Traumatic Brain Injury Undergoing Urgent Neurosurgical Intervention
The goal of this clinical trial is to compare the effects of propofol, midazolam, and dexmedetomidine on intracranial pressure control and clinical outcomes in adults with moderate-to-severe traumatic brain injury undergoing urgent neurosurgical intervention.
The main questions it aims to answer are:
Read more
- Which sedative agent provides better control of intracranial pressure, assessed by optic nerve sheath diameter (ONSD), during the first 24 hours after neurosurgical intervention?
- How do the three sedative agents compare in achieving target sedation depth, maintaining hemodynamic stability, and improving short-term clinical outcomes such as ICU mortality, duration of mechanical ventilation, and ICU length of stay?
Participants will be randomly assigned to receive propofol, midazolam, or dexmedetomidine for 24 hours of continuous sedation. Clinical, hemodynamic, and neurological outcomes will be assessed and compared among the three study groups.
Read the detailed description
Traumatic brain injury (TBI) is a major cause of mortality and long-term disability worldwide. Prevention of secondary brain injury through optimal control of intracranial pressure (ICP) is a key component of intensive care management in patients with moderate-to-severe TBI. Sedative agents are routinely used to facilitate mechanical ventilation, reduce cerebral metabolic demand, and improve ICP control. However, uncertainty remains regarding the optimal sedative agent for this patient population.
Propofol, midazolam, and dexmedetomidine are among the most commonly used sedatives in neurocritical care. Each agent has distinct pharmacological characteristics that may influence intracranial pressure, hemodynamic stability, neurological assessment, and clinical outcomes. Despite widespread use, direct comparative evidence between these agents remains limited.
This prospective randomized clinical trial aims to compare the effects of propofol, midazolam, and dexmedetomidine on intracranial pressure control and clinical outcomes in adult patients with moderate-to-severe traumatic brain injury undergoing urgent neurosurgical intervention. Intracranial pressure will be assessed noninvasively using serial optic nerve sheath diameter (ONSD) measurements obtained by ocular ultrasonography during the first 24 hours of continuous sedation.
Participants will be randomly assigned to receive one of the three sedative regimens according to a standardized protocol targeting a Richmond Agitation-Sedation Scale (RASS) score of -3 to -4. Standard neurocritical care management and analgesia protocols will be applied to all study groups.
The study will evaluate the comparative effects of the three sedative agents on intracranial pressure control, sedation quality, hemodynamic stability, adverse events, secondary brain injury, and short-term clinical outcomes. The findings are expected to provide evidence to guide sedative selection in patients with moderate-to-severe traumatic brain injury, particularly in settings where invasive intracranial pressure monitoring is not routinely available.
- Being tested
- propofol, midazolam, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Continuous intravenous propofol infusion initiated at 1 mg/kg/h and titrated within a range of 1-4 mg/kg/h to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4 during the 24-hour study intervention period.
midazolamDrug
Continuous intravenous midazolam infusion initiated at 0.03 mg/kg/h and titrated within a range of 0.02-0.1 mg/kg/h to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4 during the 24-hour study intervention period. An initial bolus dose of 0.05 mg/kg may be administered if rapid sedation is required.
DexmedetomidineDrug
Continuous intravenous dexmedetomidine infusion initiated at 0.4 μg/kg/h and titrated within a range of 0.2-0.7 μg/kg/h to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4 during the 24-hour study intervention period. No loading dose will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | Participants receive continuous intravenous propofol infusion initiated at 1 mg/kg/h and titrated to 1-4 mg/kg/h to maintain a target RASS score of -3 to -4 for 24 hours. Receives: Drug: propofol |
| Midazolam | Experimental | Participants receive continuous intravenous midazolam infusion initiated at 0.03 mg/kg/h and titrated to 0.02-0.1 mg/kg/h to maintain a target RASS score of -3 to -4 for 24 hours. Receives: Drug: midazolam |
| dexmedetomidine | Experimental | Participants receive continuous intravenous dexmedetomidine infusion initiated at 0.4 μg/kg/h and titrated to 0.2-0.7 μg/kg/h to maintain a target RASS score of -3 to -4 for 24 hours. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Pressure Control Assessed by Optic Nerve Sheath Diameter (ONSD)
Intracranial pressure control will be evaluated using serial optic nerve sheath diameter (ONSD) measurements obtained by ocular ultrasonography. The primary outcome will be the mean ONSD over the 24-hour intervention period, analyzed as a continuous measure of intracranial pressure control.
Measured: Baseline, 6 hours, 12 hours, and 24 hours after initiation of sedation
Secondary outcomes (11)
Proportion of Time at Target Sedation Level
Percentage of assessment time during which patients maintained the target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4. The Richmond Agitation-Sedation Scale ranges from +4 (combative) to -5 (unarousable). Higher scores indicate greater agitation, whereas lower scores indicate deeper sedation. The target sedation level for this study is RASS -3 to -4.
Measured: 24 hours after initiation of sedation
Mean Richmond Agitation-Sedation Scale (RASS) Score
Mean Richmond Agitation-Sedation Scale (RASS) score during the 24-hour intervention period. The RASS ranges from +4 (combative) to -5 (unarousable), with target sedation defined as -3 to -4.
Measured: 24 hours after initiation of sedation
Need for Rescue Sedation
Proportion of patients requiring rescue sedation due to failure to achieve target sedation despite maximum protocol dose.
Measured: 24 hours after initiation of sedation
Time to Achieve Target Sedation
Time from initiation of study sedative infusion until achievement of target Richmond Agitation-Sedation Scale (RASS) score (-3 to -4).The RASS ranges from +4 (combative) to -5 (unarousable)
Measured: 24 hours after initiation of sedation
Incidence of Hypotension
Incidence of hypotension, defined as mean arterial pressure (MAP) <65 mmHg or cerebral perfusion pressure (CPP) <60 mmHg.
Measured: 24 hours after initiation of study sedation
Vasopressor Requirements
Vasopressor requirements assessed by the proportion of patients requiring vasopressor support.
Measured: 24 hours after initiation of study sedation.
Incidence of Bradycardia.
Percentage of participants who develop bradycardia, defined as a sustained heart rate <50 beats per minute (bpm).
Measured: 24 hours after initiation of study sedation.
Percentage of Participants Who Developed Secondary Brain Injury ✅
Secondary brain injury will be assessed by the presence of new or progressive findings on brain computed tomography (CT) compared with baseline imaging, including new intracranial hemorrhage, progression of cerebral edema (defined as >25% increase in midline shift or worsening basal cistern effacement), new cerebral infarction, or transtentorial or uncal herniation. Brain CT scans will be reviewed by a blinded neuroradiologist.
Measured: Baseline and 24 hours after initiation of study sedation.
Duration of Mechanical Ventilation
Duration of invasive mechanical ventilation, measured as the number of days from initiation of mechanical ventilation until successful liberation from ventilatory support.
Measured: From initiation of mechanical ventilation until successful extubation, assessed for up to 30 days.
Time to Neurological Awakening
Time from discontinuation of study sedation to achievement of a Glasgow Coma Scale (GCS) motor score of ≥5. The Glasgow Coma Scale motor component ranges from 1 (no motor response) to 6 (obeys commands), with higher scores indicating better neurological function.
Measured: From discontinuation of study sedation until achievement of a Glasgow Coma Scale motor score of ≥5, assessed for up to 30 days.
ICU Mortality
Death from any cause during the ICU stay following urgent neurosurgical intervention for traumatic brain injury.
Measured: From ICU admission until ICU discharge, assessed for up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-Severe Traumatic Brain InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel treatment groups receiving continuous sedation for 24 hours following urgent neurosurgical intervention for moderate-to-severe traumatic brain injury. Group A will receive propofol initiated at 1 mg/kg/h and titrated within a range of 1-4 mg/kg/h to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4. Group B will receive midazolam initiated at 0.03 mg/kg/h and titrated within a range of 0.02-0.1 mg/kg/h to maintain the target RASS score. An initial bolus dose of 0.05 mg/kg may be administered if rapid sedation is required. Group C will receive dexmedetomidine initiated at 0.4 μg/kg/h and titrated within a range of 0.2-0.7 μg/kg/h to maintain the target RASS score. Participants will remain in their assigned treatment group throughout the intervention period, and outcomes will be compared between groups. The trial uses a prospective randomized parallel-group design with blinded
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelhameed Sayed, Aswan University
- Investigators
- Ahmed Elsaied Aly, Ph.D., Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678216
- Sponsor's protocol ID
- 1230/3/26
- Acronym
- ICP-TBI
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study contains sensitive clinical data, and sharing could compromise participant confidentiality. Data are subject to institutional policies and ethics committee restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol, Midazolam, and Dexmedetomidine on Intracranial Pressure and Clinical Outcomes in Patients With Moderate-to-Severe Traumatic Brain Injury Undergoing Urgent Neurosurgical Intervention
- ClinicalTrials.gov ID
- NCT07678216
- Acronym / sponsor ID
- ICP-TBI / 1230/3/26
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 1 Jul 2026 (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 clinical trial is to compare the effects of propofol, midazolam, and dexmedetomidine on intracranial pressure control and clinical outcomes in adults with moderate-to-severe traumatic brain injury undergoing urgent neurosurgical intervention.
The main questions it aims to answer are:
- Which sedative agent provides better control of intracranial pressure, assessed by optic nerve sheath diameter (ONSD), during the first 24 hours after neurosurgical intervention?
- How do the three sedative agents compare in achieving target sedation depth, maintaining hemodynamic stability, and improving short-term clinical outcomes such as ICU mortality, duration of mechanical ventilation, and ICU length of stay?
Participants will be randomly assigned to receive propofol, midazolam, or dexmedetomidine for 24 hours of continuous sedation. Clinical, hemodynamic, and neurological outcomes will be assessed and compared among the three study groups.
Detailed description
Traumatic brain injury (TBI) is a major cause of mortality and long-term disability worldwide. Prevention of secondary brain injury through optimal control of intracranial pressure (ICP) is a key component of intensive care management in patients with moderate-to-severe TBI. Sedative agents are routinely used to facilitate mechanical ventilation, reduce cerebral metabolic demand, and improve ICP control. However, uncertainty remains regarding the optimal sedative agent for this patient population.
Propofol, midazolam, and dexmedetomidine are among the most commonly used sedatives in neurocritical care. Each agent has distinct pharmacological characteristics that may influence intracranial pressure, hemodynamic stability, neurological assessment, and clinical outcomes. Despite widespread use, direct comparative evidence between these agents remains limited.
This prospective randomized clinical trial aims to compare the effects of propofol, midazolam, and dexmedetomidine on intracranial pressure control and clinical outcomes in adult patients with moderate-to-severe traumatic brain injury undergoing urgent neurosurgical intervention. Intracranial pressure will be assessed noninvasively using serial optic nerve sheath diameter (ONSD) measurements obtained by ocular ultrasonography during the first 24 hours of continuous sedation.
Participants will be randomly assigned to receive one of the three sedative regimens according to a standardized protocol targeting a Richmond Agitation-Sedation Scale (RASS) score of -3 to -4. Standard neurocritical care management and analgesia protocols will be applied to all study groups.
The study will evaluate the comparative effects of the three sedative agents on intracranial pressure control, sedation quality, hemodynamic stability, adverse events, secondary brain injury, and short-term clinical outcomes. The findings are expected to provide evidence to guide sedative selection in patients with moderate-to-severe traumatic brain injury, particularly in settings where invasive intracranial pressure monitoring is not routinely available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel treatment groups receiving continuous sedation for 24 hours following urgent neurosurgical intervention for moderate-to-severe traumatic brain injury. Group A will receive propofol initiated at 1 mg/kg/h and titrated within a range of 1-4 mg/kg/h to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4. Group B will receive midazolam initiated at 0.03 mg/kg/h and titrated within a range of 0.02-0.1 mg/kg/h to maintain the target RASS score. An initial bolus dose of 0.05 mg/kg may be administered if rapid sedation is required. Group C will receive dexmedetomidine initiated at 0.4 μg/kg/h and titrated within a range of 0.2-0.7 μg/kg/h to maintain the target RASS score. Participants will remain in their assigned treatment group throughout the intervention period, and outcomes will be compared between groups. The trial uses a prospective randomized parallel-group design with blinded
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: propofolParticipants receive continuous intravenous propofol infusion initiated at 1 mg/kg/h and titrated to 1-4 mg/kg/h to maintain a target RASS score of -3 to -4 for 24 hours. |
| Midazolam | Experimental | Drug: midazolamParticipants receive continuous intravenous midazolam infusion initiated at 0.03 mg/kg/h and titrated to 0.02-0.1 mg/kg/h to maintain a target RASS score of -3 to -4 for 24 hours. |
| dexmedetomidine | Experimental | Drug: DexmedetomidineParticipants receive continuous intravenous dexmedetomidine infusion initiated at 0.4 μg/kg/h and titrated to 0.2-0.7 μg/kg/h to maintain a target RASS score of -3 to -4 for 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
Key exclusion criteria (11 listed)
- The Relative refusal to participate in the research.
- Known allergy or contraindication to propofol, midazolam, or dexmedetomidine
- Pre-existing neurological disorders (epilepsy, prior stroke, brain tumors, dementia) that may interfere with outcome assessment
- Severe hepatic dysfunction (Child-Pugh Class C) or acute liver failure
- Severe renal dysfunction (eGFR <30 mL/min/1.73m² or requiring renal replacement therapy)
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 |
|---|---|---|
| propofolContinuous intravenous propofol infusion initiated at 1 mg/kg/h and titrated within a range of 1-4 mg/kg/h to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4 during the 24-hour study intervention period. | Drug | Propofol |
| midazolamContinuous intravenous midazolam infusion initiated at 0.03 mg/kg/h and titrated within a range of 0.02-0.1 mg/kg/h to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4 during the 24-hour study intervention period. An initial bolus dose of 0.05 mg/kg may be administered if rapid sedation is required. | Drug | Midazolam |
| DexmedetomidineContinuous intravenous dexmedetomidine infusion initiated at 0.4 μg/kg/h and titrated within a range of 0.2-0.7 μg/kg/h to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4 during the 24-hour study intervention period. No loading dose will be administered. | Drug | dexmedetomidine |
Primary outcome
Intracranial Pressure Control Assessed by Optic Nerve Sheath Diameter (ONSD)
Time frame: Baseline, 6 hours, 12 hours, and 24 hours after initiation of sedation
Intracranial pressure control will be evaluated using serial optic nerve sheath diameter (ONSD) measurements obtained by ocular ultrasonography. The primary outcome will be the mean ONSD over the 24-hour intervention period, analyzed as a continuous measure of intracranial pressure control.
11 secondary outcomes
Proportion of Time at Target Sedation Level
Time frame: 24 hours after initiation of sedation
Mean Richmond Agitation-Sedation Scale (RASS) Score
Time frame: 24 hours after initiation of sedation
Need for Rescue Sedation
Time frame: 24 hours after initiation of sedation
Time to Achieve Target Sedation
Time frame: 24 hours after initiation of sedation
Incidence of Hypotension
Time frame: 24 hours after initiation of study sedation
Vasopressor Requirements
Time frame: 24 hours after initiation of study sedation.
Incidence of Bradycardia.
Time frame: 24 hours after initiation of study sedation.
Percentage of Participants Who Developed Secondary Brain Injury ✅
Time frame: Baseline and 24 hours after initiation of study sedation.
Duration of Mechanical Ventilation
Time frame: From initiation of mechanical ventilation until successful extubation, assessed for up to 30 days.
Time to Neurological Awakening
Time frame: From discontinuation of study sedation until achievement of a Glasgow Coma Scale motor score of ≥5, assessed for up to 30 days.
ICU Mortality
Time frame: From ICU admission until ICU discharge, assessed for up to 30 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 1 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study contains sensitive clinical data, and sharing could compromise participant confidentiality. Data are subject to institutional policies and ethics committee restrictions.
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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.
Ahmed Elsaied Aly, Ph.D. study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol, midazolam and Dexmedetomidine in people with Moderate-to-Severe Traumatic Brain Injury, run by Aswan University at 1 site in Egypt.
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 11 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 1 Jul 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 Egypt. 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 Mohamed Abdelhamed, M.Sc (+201061651065, mohamed.said@med.aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial Pressure Control Assessed by Optic Nerve Sheath Diameter (ONSD) (time frame: Baseline, 6 hours, 12 hours, and 24 hours after initiation of sedation). 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 1 Jul 2026.