Acute Ischemic StrokePhase 2CARE-EVTNCT06339411
Cerebrolysin After Reperfusion in Extended-window EndoVascular Thrombectomy
A Phase 2 study testing Cerebrolysin in people with Acute Ischemic Stroke, run by Chang Gung Memorial Hospital.
Trial summary
Acute ischemic stroke caused by blockage of a large brain artery can lead to severe disability. Endovascular thrombectomy is a catheter-based procedure used to remove the blood clot and restore blood flow. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Cerebrolysin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2030
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years.
- Acute anterior-circulation ischemic stroke caused by internal carotid artery or M1 or M2 middle cerebral artery occlusion confirmed by computed tomography angiography.
- Stroke onset-to-groin-puncture interval greater than 6 hours and no more than 24 hours.
- Prestroke modified Rankin Scale score of 0 to 2.
- Baseline National Institutes of Health Stroke Scale score of at least 6 with cortical signs.
- Alberta Stroke Program Early Computed Tomography Score greater than 3.
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- Computed tomography perfusion target mismatch defined as ischemic core volume less than 70 mL, mismatch ratio at least 1.8, and mismatch volume at least 15 mL.
- Moderate-to-good collateral circulation, defined as filling of more than 50% of the middle cerebral artery territory on computed tomography angiography.
- Successful endovascular reperfusion, defined as modified Thrombolysis in Cerebral Infarction grade 2b or 3, confirmed before randomization.
- Study treatment can be initiated within 36 hours of stroke onset.
- Written informed consent obtained before randomization from the participant or a legally authorized representative.
Who cannot join
- Life expectancy less than 6 months or a serious medical, neurological, or psychiatric condition likely to interfere with study treatment, follow-up, or outcome assessment.
- Current pregnancy or breastfeeding.
- Known iodinated contrast allergy that precludes required endovascular or imaging procedures.
- Acute or chronic renal failure with creatinine clearance less than 30 mL/min.
- Known hypersensitivity or contraindication to Cerebrolysin.
- Aspartate aminotransferase or alanine aminotransferase greater than 2 times the upper limit of normal, or total bilirubin greater than 2 mg/dL.
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- Blood glucose less than 50 mg/dL or greater than 400 mg/dL.
- Platelet count less than 50,000/mm3 or international normalized ratio greater than 3.
- Seizure at stroke onset that prevents reliable neurological assessment.
- Pre-existing intracranial hemorrhage or multiple vascular occlusions on baseline neuroimaging.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cerebrolysin After Reperfusion in Extended-Window Endovascular Thrombectomy: A Multicenter Randomized Controlled Trial
Acute ischemic stroke caused by blockage of a large brain artery can lead to severe disability. Endovascular thrombectomy is a catheter-based procedure used to remove the blood clot and restore blood flow. It can benefit selected patients treated 6 to 24 hours after stroke onset, but some patients remain disabled even when the blocked artery is successfully reopened. Ongoing injury to brain tissue, small blood vessels, and the blood-brain barrier may contribute to this incomplete recovery.
This multicenter randomized clinical trial will evaluate whether Cerebrolysin, given after successful extended-window endovascular thrombectomy, can reduce brain tissue injury and support recovery. The study will enroll 100 adults aged 18 to 80 years at three stroke centers in Taiwan. Participants will be randomly assigned, after successful reperfusion has been confirmed, to receive either Cerebrolysin 30 mL or a matched normal saline placebo by intravenous infusion once daily for 10 consecutive days. The first infusion will begin within 36 hours of stroke onset. All participants will also receive standard stroke care and rehabilitation.
Read more
The primary outcome is final infarct volume measured by diffusion-weighted magnetic resonance imaging on Day 7 to Day 10. Other outcomes include functional recovery at 3 and 12 months, neurological improvement, symptomatic intracranial hemorrhage, cerebral edema, recurrent stroke, mortality, cognition, language, and mood. The study will also examine blood-brain barrier injury using computed tomography perfusion, dynamic contrast-enhanced magnetic resonance imaging, and serial plasma Claudin-5 measurements.
This study will determine whether Cerebrolysin shows evidence of reducing postreperfusion brain injury after successful thrombectomy and will help guide the design of a larger trial focused on clinical outcomes.
Read the detailed description
This is an investigator-initiated, multicenter, randomized, placebo-controlled, participant- and outcome-assessor-blinded proof-of-concept trial conducted at three stroke centers within the Chang Gung Memorial Hospital system in Taiwan.
The study will enroll 100 participants aged 18 to 80 years with anterior-circulation acute ischemic stroke caused by internal carotid artery or M1/M2 middle cerebral artery occlusion. Eligible participants must undergo endovascular thrombectomy more than 6 hours and no more than 24 hours after stroke onset and must achieve successful reperfusion, defined as modified Thrombolysis in Cerebral Infarction grade 2b or 3, before randomization.
Participants will be randomized in a 1:1 ratio to receive Cerebrolysin 30 mL diluted in 70 mL normal saline or matched normal saline placebo. Study treatment will be administered intravenously over 60 minutes once daily for 10 consecutive days and will begin after randomization and within 36 hours of stroke onset. Both groups will receive standard post-thrombectomy stroke care, secondary prevention, and rehabilitation.
The primary outcome is final infarct volume measured on diffusion-weighted magnetic resonance imaging performed on Day 7 to Day 10. The key secondary clinical outcome is functional independence, defined as a modified Rankin Scale score of 0 to 2, at Month 3. Other outcomes include ordinal modified Rankin Scale, National Institutes of Health Stroke Scale, Barthel Index, symptomatic intracranial hemorrhage, asymptomatic hemorrhagic transformation, cerebral edema, recurrent stroke, all-cause mortality, vessel patency, cognition, language, and mood through Month 12.
Mechanistic assessments will evaluate blood-brain barrier injury. Computed tomography perfusion-derived blood-brain barrier permeability will be measured before thrombectomy and approximately 24 hours after reperfusion. Dynamic contrast-enhanced magnetic resonance imaging will assess subacute permeability on Day 7 to Day 10. Plasma Claudin-5, an exploratory marker of endothelial tight-junction injury, will be measured at groin puncture before reperfusion, 24 hours after reperfusion, and on Day 7.
The trial is designed to determine whether adjunctive Cerebrolysin reduces tissue-level injury and provides biological signals consistent with preservation of blood-brain barrier integrity after successful extended-window thrombectomy. The study is not powered to establish definitive clinical efficacy, and clinical and mechanistic secondary analyses will be considered exploratory.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Cerebrolysin, Normal saline placebo
- Keywords
- Endovascular Thrombectomy, Large Vessel Occlusion, Extended Time Window, Cerebrolysin, Blood-Brain Barrier, Claudin-5, Neuroprotection, Computed Tomography Perfusion
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebrolysinDrug
Cerebrolysin 30 mL diluted in 70 mL normal saline will be administered intravenously over 60 minutes once daily for 10 consecutive days. Treatment will begin after successful endovascular reperfusion and randomization and within 36 hours of stroke onset.
Normal saline placeboDrug
Also called cerebrolysin
Normal saline 100 mL will be administered intravenously over 60 minutes once daily for 10 consecutive days according to the same schedule as Cerebrolysin. Infusion bags, drip chambers, and visible tubing will be covered to maintain masking.
| Study group | Role | What they receive |
|---|---|---|
| Cerebrolysin After Successful Extended-Window Thrombectomy | Experimental | Participants will receive Cerebrolysin 30 mL diluted in 70 mL normal saline, administered intravenously over 60 minutes once daily for 10 consecutive days. The first infusion will begin after successful endovascular reperfusion and randomization and within 36 hours of stroke onset. All participants will also receive standard post-thrombectomy stroke care, secondary prevention, and rehabilitation. Receives: Drug: Cerebrolysin |
| Matched Placebo After Successful Extended-Window Thrombectomy | Placebo comparator | Participants will receive 100 mL normal saline placebo, administered intravenously over 60 minutes once daily for 10 consecutive days according to the same schedule as the experimental arm. The first infusion will begin after successful endovascular reperfusion and randomization and within 36 hours of stroke onset. All participants will also receive standard post-thrombectomy stroke care, secondary prevention, and rehabilitation. Receives: Drug: Normal saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final Infarct Volume on Diffusion-Weighted MRI
Final infarct volume will be quantified on Day 7-10 diffusion-weighted magnetic resonance imaging using standardized semiautomated lesion segmentation with manual correction when required. Imaging readers will be blinded to treatment allocation. Participants who are unable to undergo MRI will remain in the intention-to-treat population, and missing primary-outcome data will be addressed using prespecified imputation and sensitivity analyses.
Measured: Day 7 to Day 10 after stroke onset
Secondary outcomes (6)
Functional Independence Defined as Modified Rankin Scale Score 0-2
The proportion of participants achieving functional independence, defined as a modified Rankin Scale score of 0 to 2, will be assessed using a validated structured interview.
Measured: Month 3 and Month 12 after stroke onset
Symptomatic Intracranial Hemorrhage
Symptomatic intracranial hemorrhage will be defined according to the ECASS III criteria.
Measured: Within 7 days after stroke onset
Change in Computed Tomography Perfusion-Derived Blood-Brain Barrier Permeability
Blood-brain barrier permeability surface area product will be measured using the Patlak model before thrombectomy and approximately 24 hours after reperfusion. The change from baseline will be compared between treatment groups.
Measured: Pre-EVT and 24 ± 6 hours after reperfusion
Plasma Claudin-5 Concentration-Time Profile
Plasma Claudin-5 concentrations will be measured as an exploratory marker of endothelial tight-junction injury.
Measured: At groin puncture before reperfusion, 24 ± 6 hours after reperfusion, and Day 7 ± 1
Montreal Cognitive Assessment Score
Global cognitive function will be assessed using the Montreal Cognitive Assessment, with lower scores indicating greater cognitive impairment.
Measured: Months 3, 6, and 12
Recurrent Stroke
The occurrence of recurrent ischemic or hemorrhagic stroke will be recorded through clinical follow-up and review of available medical records.
Measured: Through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio after successful endovascular reperfusion to receive either intravenous Cerebrolysin or matched normal saline placebo in parallel for 10 consecutive days. Randomization will occur only after confirmation of modified Thrombolysis in Cerebral Infarction grade 2b or 3 reperfusion.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- EVER Pharma France SAS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339411
- Sponsor's protocol ID
- 202302239A3
- Acronym
- CARE-EVT
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data may be shared after publication of the primary trial results upon reasonable request. Data sharing will require approval by the investigators, applicable ethical and regulatory review, protection of participant confidentiality, institutional approval, and execution of a data-use agreement. The trial protocol and statistical analysis plan will be made available with the primary trial publication. Statistical code may also be shared upon reasonable request, subject to institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrolysin After Reperfusion in Extended-Window Endovascular Thrombectomy: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06339411
- Acronym / sponsor ID
- CARE-EVT / 202302239A3
- Conditions
- Acute Ischemic Stroke
- Keywords
- Endovascular Thrombectomy, Large Vessel Occlusion, Extended Time Window, Cerebrolysin, Blood-Brain Barrier, Claudin-5, Neuroprotection, Computed Tomography Perfusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- EVER Pharma France SAS
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 Apr 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.
Acute ischemic stroke caused by blockage of a large brain artery can lead to severe disability. Endovascular thrombectomy is a catheter-based procedure used to remove the blood clot and restore blood flow. It can benefit selected patients treated 6 to 24 hours after stroke onset, but some patients remain disabled even when the blocked artery is successfully reopened. Ongoing injury to brain tissue, small blood vessels, and the blood-brain barrier may contribute to this incomplete recovery.
This multicenter randomized clinical trial will evaluate whether Cerebrolysin, given after successful extended-window endovascular thrombectomy, can reduce brain tissue injury and support recovery. The study will enroll 100 adults aged 18 to 80 years at three stroke centers in Taiwan. Participants will be randomly assigned, after successful reperfusion has been confirmed, to receive either Cerebrolysin 30 mL or a matched normal saline placebo by intravenous infusion once daily for 10 consecutive days. The first infusion will begin within 36 hours of stroke onset. All participants will also receive standard stroke care and rehabilitation.
The primary outcome is final infarct volume measured by diffusion-weighted magnetic resonance imaging on Day 7 to Day 10. Other outcomes include functional recovery at 3 and 12 months, neurological improvement, symptomatic intracranial hemorrhage, cerebral edema, recurrent stroke, mortality, cognition, language, and mood. The study will also examine blood-brain barrier injury using computed tomography perfusion, dynamic contrast-enhanced magnetic resonance imaging, and serial plasma Claudin-5 measurements.
This study will determine whether Cerebrolysin shows evidence of reducing postreperfusion brain injury after successful thrombectomy and will help guide the design of a larger trial focused on clinical outcomes.
Detailed description
This is an investigator-initiated, multicenter, randomized, placebo-controlled, participant- and outcome-assessor-blinded proof-of-concept trial conducted at three stroke centers within the Chang Gung Memorial Hospital system in Taiwan.
The study will enroll 100 participants aged 18 to 80 years with anterior-circulation acute ischemic stroke caused by internal carotid artery or M1/M2 middle cerebral artery occlusion. Eligible participants must undergo endovascular thrombectomy more than 6 hours and no more than 24 hours after stroke onset and must achieve successful reperfusion, defined as modified Thrombolysis in Cerebral Infarction grade 2b or 3, before randomization.
Participants will be randomized in a 1:1 ratio to receive Cerebrolysin 30 mL diluted in 70 mL normal saline or matched normal saline placebo. Study treatment will be administered intravenously over 60 minutes once daily for 10 consecutive days and will begin after randomization and within 36 hours of stroke onset. Both groups will receive standard post-thrombectomy stroke care, secondary prevention, and rehabilitation.
The primary outcome is final infarct volume measured on diffusion-weighted magnetic resonance imaging performed on Day 7 to Day 10. The key secondary clinical outcome is functional independence, defined as a modified Rankin Scale score of 0 to 2, at Month 3. Other outcomes include ordinal modified Rankin Scale, National Institutes of Health Stroke Scale, Barthel Index, symptomatic intracranial hemorrhage, asymptomatic hemorrhagic transformation, cerebral edema, recurrent stroke, all-cause mortality, vessel patency, cognition, language, and mood through Month 12.
Mechanistic assessments will evaluate blood-brain barrier injury. Computed tomography perfusion-derived blood-brain barrier permeability will be measured before thrombectomy and approximately 24 hours after reperfusion. Dynamic contrast-enhanced magnetic resonance imaging will assess subacute permeability on Day 7 to Day 10. Plasma Claudin-5, an exploratory marker of endothelial tight-junction injury, will be measured at groin puncture before reperfusion, 24 hours after reperfusion, and on Day 7.
The trial is designed to determine whether adjunctive Cerebrolysin reduces tissue-level injury and provides biological signals consistent with preservation of blood-brain barrier integrity after successful extended-window thrombectomy. The study is not powered to establish definitive clinical efficacy, and clinical and mechanistic secondary analyses will be considered exploratory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio after successful endovascular reperfusion to receive either intravenous Cerebrolysin or matched normal saline placebo in parallel for 10 consecutive days. Randomization will occur only after confirmation of modified Thrombolysis in Cerebral Infarction grade 2b or 3 reperfusion.
| Arm | Type | Receives |
|---|---|---|
| Cerebrolysin After Successful Extended-Window Thrombectomy | Experimental | Drug: CerebrolysinParticipants will receive Cerebrolysin 30 mL diluted in 70 mL normal saline, administered intravenously over 60 minutes once daily for 10 consecutive days. The first infusion will begin after successful endovascular reperfusion and randomization and within 36 hours of stroke onset. All participants will also receive standard post-thrombectomy stroke care, secondary prevention, and rehabilitation. |
| Matched Placebo After Successful Extended-Window Thrombectomy | Placebo comparator | Drug: Normal saline placeboParticipants will receive 100 mL normal saline placebo, administered intravenously over 60 minutes once daily for 10 consecutive days according to the same schedule as the experimental arm. The first infusion will begin after successful endovascular reperfusion and randomization and within 36 hours of stroke onset. All participants will also receive standard post-thrombectomy stroke care, secondary prevention, and rehabilitation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 to 80 years.
- Acute anterior-circulation ischemic stroke caused by internal carotid artery or M1 or M2 middle cerebral artery occlusion confirmed by computed tomography angiography.
- Stroke onset-to-groin-puncture interval greater than 6 hours and no more than 24 hours.
- Prestroke modified Rankin Scale score of 0 to 2.
- Baseline National Institutes of Health Stroke Scale score of at least 6 with cortical signs.
Key exclusion criteria (10 listed)
- Life expectancy less than 6 months or a serious medical, neurological, or psychiatric condition likely to interfere with study treatment, follow-up, or outcome assessment.
- Current pregnancy or breastfeeding.
- Known iodinated contrast allergy that precludes required endovascular or imaging procedures.
- Acute or chronic renal failure with creatinine clearance less than 30 mL/min.
- Known hypersensitivity or contraindication to Cerebrolysin.
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 |
|---|---|---|
| CerebrolysinCerebrolysin 30 mL diluted in 70 mL normal saline will be administered intravenously over 60 minutes once daily for 10 consecutive days. Treatment will begin after successful endovascular reperfusion and randomization and within 36 hours of stroke onset. | Drug | Cerebrolysin After Successful Extended-Window Thrombectomy |
| Normal saline placeboAlso: cerebrolysinNormal saline 100 mL will be administered intravenously over 60 minutes once daily for 10 consecutive days according to the same schedule as Cerebrolysin. Infusion bags, drip chambers, and visible tubing will be covered to maintain masking. | Drug | Matched Placebo After Successful Extended-Window Thrombectomy |
Primary outcome
Final Infarct Volume on Diffusion-Weighted MRI
Time frame: Day 7 to Day 10 after stroke onset
Final infarct volume will be quantified on Day 7-10 diffusion-weighted magnetic resonance imaging using standardized semiautomated lesion segmentation with manual correction when required. Imaging readers will be blinded to treatment allocation. Participants who are unable to undergo MRI will remain in the intention-to-treat population, and missing primary-outcome data will be addressed using prespecified imputation and sensitivity analyses.
6 secondary outcomes
Functional Independence Defined as Modified Rankin Scale Score 0-2
Time frame: Month 3 and Month 12 after stroke onset
Symptomatic Intracranial Hemorrhage
Time frame: Within 7 days after stroke onset
Change in Computed Tomography Perfusion-Derived Blood-Brain Barrier Permeability
Time frame: Pre-EVT and 24 ± 6 hours after reperfusion
Plasma Claudin-5 Concentration-Time Profile
Time frame: At groin puncture before reperfusion, 24 ± 6 hours after reperfusion, and Day 7 ± 1
Montreal Cognitive Assessment Score
Time frame: Months 3, 6, and 12
Recurrent Stroke
Time frame: Through Month 12
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 11 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data may be shared after publication of the primary trial results upon reasonable request. Data sharing will require approval by the investigators, applicable ethical and regulatory review, protection of participant confidentiality, institutional approval, and execution of a data-use agreement. The trial protocol and statistical analysis plan will be made available with the primary trial publication. Statistical code may also be shared upon reasonable request, subject to institutional approval.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cerebrolysin in people with Acute Ischemic Stroke, run by Chang Gung Memorial Hospital.
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 11 inclusion and 10 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Chien H Chang, MD (+886978009593, cva9514@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final Infarct Volume on Diffusion-Weighted MRI (time frame: Day 7 to Day 10 after stroke onset). 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 11 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.