Stroke, Acute IschemicPhase 3NCT05857046
Cerebroprotective Effect of Melatonin in Stroke
A Phase 3 study testing Melatonin 10 MG in people with Stroke, Acute Ischemic and Strokes Thrombotic, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
Stroke is a leading cause of mortality and disability in Mexico and worldwide. Although current treatment strategies focus on removing oclussion, they do not interrupt the signaling cascade of neuronal damage. Thus, the search for a cerebroprotective agent that can protect the entire brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic, Strokes Thrombotic
- What is being tested?
- Melatonin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2024to 14 Jul 2025
- Phase
- Phase 3
- 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
- Patients presenting to the Emergency Department with acute ischemic CVD
- Affiliated to the IMSS and ISSSTE,
- Patients with NIHSS of 5-25 points
- Patients with an evolution of less than 24 hours,
- Patients over 18 years of age,
- Patients with no history of disease that conditions neurological deficit prior to the event
Who cannot join
- Patients with cancer, rheumatic diseases, AIDS, immunological disease or conical infection, connective tissue diseases or CVD in the last 3 months,
- Pregnant patients, with renal or hepatic insufficiency, allergic to iodine
- Patients who receive thrombolytic
- Patient who were taking illicit drugs the following medicine: Imipramine, Thioridazine, Cyproterone, Teriflunomide, Abiraterone acetate, deferasirox, obeticholic acid, peginterferon α2b, vemurafenib.
- Elimination Criteria:
- Patients who have an allergic reaction to melatonin
- Patients who do not keep follow-up appointments
- Patients who wish to leave the study
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Georgina Ortiz-Martínez
Morelia, Michoacán, 58290
Georgina Ortiz-Martínez, MC, +524434107211, gortizm001@gmail.com
Georgina Ortiz Martínez, MC, +524434107211, gortizm001@gmail.com
About this study
Official title: Cerebroprotective Effect of Melatonin in Acute Ischemic Stroke
Stroke is a leading cause of mortality and disability in Mexico and worldwide. Although current treatment strategies focus on removing oclussion, they do not interrupt the signaling cascade of neuronal damage. Thus, the search for a cerebroprotective agent that can protect the entire brain. Melatonin has been proposed as a potential cerebroprotective agent due to its antioxidant, anti-inflammatory, antiapoptotic, and immunomodulatory effects, which oppose the pathophysiological mechanisms of cerebrovascular disease. Melatonin has the potential to improve stroke outcomes and reduce the risk of disability and mortality, making it a promising therapeutic option for stroke patients.
To assess the efficacy of melatonin in patients with acute ischemic CVD, improve clinical outcome, and infarct volume.
Read the detailed description
JUSTIFICATION AND OBJECTIVES The objective of this study is to evaluate the protective effect of melatonin on the brain in patients with cerebral infarction. Cerebral infarction is the death of a small part of the brain that can leave moderate or severe disabilities, such as paralysis or death. The current treatment does not attempt to stop all the mechanisms of brain damage that occur with this disease. Melatonin is a substance that probably protects the brain by regulating cell responses to decrease damage and death of brain cells, in addition to decreasing and cushioning the secretion of substances that produce greater damage at the site of the lesion. These effects have been tested in other heart and neurological diseases in children and adults. However, its effectiveness in this disease in humans has not been studied, so it will be evaluated in this study. This medication is already approved for use in humans to improve sleep quality, so its use is safe, and the side effects are mild and may consist of headache, feeling sleepy during the day, and dizziness. These effects are discussed in detail in the risks and discomfort section.
PROCEDURES You will receive the usual treatment and studies for the care of cerebral infarction. In addition, you will be administered melatonin or lactose orally, forming two groups to evaluate the medication's effectiveness. The group will be assigned in a sequentially numbered envelope that I will give you containing your medication, which was previously sorted by someone outside the research, so neither the researcher, nor the doctor, nor you will know which group you are in. It is essential to mention that lactose tablets will have no effect.
The treatment consists of one tablet every 12 hours for 7 days and then one tablet every 24 hours at night until completing 83 days. We will perform a head CT scan upon admission, on day 2, and on day 90. We will also take blood samples for the laboratory (approximately two teaspoons of blood) on days 0 (upon admission), 5, 30, and 90 to measure substances in the blood that may be modified by the medication and confirm its protective effect on the brain. During your hospital stay, your treating physician will evaluate you daily, and we will perform evaluations on days 3 and 5. Once discharged, the patient will attend monthly medical follow-up appointments on days 30, 60, and 90 after the infarction.
The blood samples will be stored for later evaluation, within a period of fewer than 3 years, with the support of the Universidad Michoacana de San Nicolás de Hidalgo and the Centro de Investigación Biomédica de Michoacán. These samples may be used for future research if you authorize them.
If you decide to participate, you will take your medication according to the instructions. We will monitor you during your hospitalization, and you will attend monthly appointments on days 30, 60, and 90. During these appointments, we will perform clinical evaluations, administer questionnaires, conduct a CT scan, take blood samples, and provide melatonin or a placebo. Each appointment will require 60 minutes to perform all the interventions mentioned.
During your illness, you may experience complications specific to cerebral infarction, such as infections, ulcers, or cerebral hemorrhage, which will be addressed, and only in the case of a severe infection, you will be withdrawn from the study.
No travel expenses will be provided for follow-up appointments. BENEFITS AT THE END OF THE STUDY There will be no economic benefits for the patient participating in the study. At the end of the study, we will have gained more knowledge about the effect of melatonin on brain protection for patients with embolism, in order to offer another alternative in treatment that can decrease the complications caused by this disease. The administration of the medication is experimental and we hope that by receiving it, the patient may experience clinical improvement and a decrease in disability, although it is possible that it may not have any effect on the patient.
RISKS AND DISCOMFORT Melatonin has been shown to be a safe medication and is authorized for use in children and adults for the treatment of insomnia and disorders caused by changes in time zone due to travel or working night shifts. This study will evaluate the effectiveness of melatonin in the clinical development of the disease and its complications. By taking this medication, you may experience the following in order of frequency: drowsiness (28%), fatigue (25%), mood changes (16.7%), headache (13.3%), vomiting (13.3%), and hives (5%). If any of these symptoms occur, please contact us to determine the appropriate course of action, whether it be monitoring, treatment, hospitalization, or discontinuation of melatonin. In rare cases, you may experience increased activity, restlessness, decreased temperature, skin rash, insomnia, burping, tearing, fatigue, feeling heavy, nausea, decreased appetite, tiredness, or nighttime urinary incontinence. Again, if any of these symptoms occur, please contact us to determine the appropriate course of action.
The blood sample collection may cause slight pain from the needle and bruising at the puncture site. If these symptoms are not tolerable, please contact us at the phone numbers provided or go to the hospital's emergency department. You will also have an open appointment for emergency services when needed.
RESULTS INFORMATION AND TREATMENT ALTERNATIVES The complete results of this study will be available at the end of 2025 and will be sent to your registered email or phone number. You will be informed about the type of treatment received the results of your studies, as well as the results of the project. If a new treatment that improves your medical condition is discovered during the study, you will be informed immediately.
If any unforeseen events occur directly caused by the research, you will be treated at the IMSS or ISSSTE, depending on the institute you are registered with.
PARTICIPATION OR WITHDRAWAL Your participation is completely voluntary, and you may ask any questions you deem necessary at any time should you have any doubts. You may make the decision that you consider best, without this affecting your relationship with the IMSS or ISSSTE Institute (according to your registration). If you choose to participate in the study, you may leave the study at any time without affecting your care or relationship with the Institute or your doctor, and you may continue with your usual care and treatment.
If you decide to participate, you will have a contact person to stay in communication with the researcher whenever you deem it necessary.
If you choose not to participate, your relationship and care at the institute or with your doctor will not be affected, and you may continue with your usual care and treatment.
- Conditions
- Stroke, Acute Ischemic, Strokes Thrombotic
- Being tested
- Melatonin 10 MG, Placebo
- Keywords
- Melatonin, Cerebroprotective
- Medical subject headings
- Ischemic Stroke, Thrombotic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 10 MGDrug
Also called Cronocaps
Patients received extended-release melatonin 10 mg PO every 12 hours for 7 days and then every 24 hours for 83 days
PlaceboOther
Patients received placebo every 12 hours for 7 days and then every 24 hours for 83 days
| Study group | Role | What they receive |
|---|---|---|
| Melatonin group | Active comparator | Melatonin group will receive prolonged released melatonin tablet 10mg for 7 days, then 10 mg for 83 days. Receives: Drug: Melatonin 10 MG; Other: Placebo |
| Placebo group | Placebo comparator | Placebo group will receive placebo tablet for 7 days, then for 83 days. Receives: Drug: Melatonin 10 MG; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional outcome and mortality
Is considered improvement, if present a decrease of NIHSS of 10 points on day 30, Or if you have one rating of 0-1 points before the day 7, from the start of symptoms. Is considered deterioration if NIHSS increases more than 4 points the first 5 days of the stroke.
Measured: 3 months
Secondary outcomes (5)
Change in infarct volume
Evaluating the infarct volume size in the placebo and melatonin groups. RR and CI will be calculated. Each one of the parameters will determine effective if we get a RR>1 and a CI, which does not include 1.
Measured: 3 months
Change in inflammatory biomarkers
It will be evaluated the magnitude of the association between the medication and the the desired effect, evaluating the anti-inflammatory (IL-6) effect between the placebo and melatonin groups. RR and CI will be calculated. Each one of parameters and will determine effective if we get a RR>1, and a CI which does not include 1.
Measured: 7 days
Change in antiapoptotic biomarkers
It will be evaluated the magnitude of the association between the medication and the the desired effect, evaluating the antiapoptotic effect (Casp-3), between the placebo and melatonin groups. RR and CI will be calculated. Each one of parameters and will determine effective if we get a RR>1, and a CI which does not include 1.
Measured: 7 days
Change in antioxidant biomarkers
It will be evaluated the magnitude of the association between the medication and the the desired effect, evaluating the antioxidant effect (SOD), between the placebo and melatonin groups. RR and CI will be calculated. Each one of parameters and will determine effective if we get a RR>1, and a CI which does not include 1.
Measured: 3 months
Change endothelial damage
It will be evaluated the magnitude of the association between the medication and the the desired effect, evaluating the endothelial damage (FVW), between the placebo and melatonin groups. RR and CI will be calculated. Each one of parameters and will determine effective if we get a RR>1, and a CI which does not include 1.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Mar 2024
- Primary completion15 Mar 2025 (estimated)
- Study completion14 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Acute IschemicStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A phase IIIb clinical trial, randomized double-blind, parallel
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- Instituto Mexicano del Seguro Social, Universidad Michoacana de San Nicolás de Hidalgo, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Responsible party
- Principal investigator, Georgina Ortiz-Martínez, Coordinación de Investigación en Salud, Mexico
- Investigators
- Georgina Ortiz-Martínez, MC, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857046
- Sponsor's protocol ID
- HGZ83 Morelia
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2023
- Last updated
- 5 Mar 2024
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebroprotective Effect of Melatonin in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05857046
- Acronym / sponsor ID
- HGZ83 Morelia
- Conditions
- Stroke, Acute Ischemic, Strokes Thrombotic
- Keywords
- Melatonin, Cerebroprotective
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- Instituto Mexicano del Seguro Social, Universidad Michoacana de San Nicolás de Hidalgo, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 14 Jul 2025 (estimated)
- First posted
- 12 May 2023 (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.
Stroke is a leading cause of mortality and disability in Mexico and worldwide. Although current treatment strategies focus on removing oclussion, they do not interrupt the signaling cascade of neuronal damage. Thus, the search for a cerebroprotective agent that can protect the entire brain. Melatonin has been proposed as a potential cerebroprotective agent due to its antioxidant, anti-inflammatory, antiapoptotic, and immunomodulatory effects, which oppose the pathophysiological mechanisms of cerebrovascular disease. Melatonin has the potential to improve stroke outcomes and reduce the risk of disability and mortality, making it a promising therapeutic option for stroke patients.
To assess the efficacy of melatonin in patients with acute ischemic CVD, improve clinical outcome, and infarct volume.
Detailed description
JUSTIFICATION AND OBJECTIVES The objective of this study is to evaluate the protective effect of melatonin on the brain in patients with cerebral infarction. Cerebral infarction is the death of a small part of the brain that can leave moderate or severe disabilities, such as paralysis or death. The current treatment does not attempt to stop all the mechanisms of brain damage that occur with this disease. Melatonin is a substance that probably protects the brain by regulating cell responses to decrease damage and death of brain cells, in addition to decreasing and cushioning the secretion of substances that produce greater damage at the site of the lesion. These effects have been tested in other heart and neurological diseases in children and adults. However, its effectiveness in this disease in humans has not been studied, so it will be evaluated in this study. This medication is already approved for use in humans to improve sleep quality, so its use is safe, and the side effects are mild and may consist of headache, feeling sleepy during the day, and dizziness. These effects are discussed in detail in the risks and discomfort section.
PROCEDURES You will receive the usual treatment and studies for the care of cerebral infarction. In addition, you will be administered melatonin or lactose orally, forming two groups to evaluate the medication's effectiveness. The group will be assigned in a sequentially numbered envelope that I will give you containing your medication, which was previously sorted by someone outside the research, so neither the researcher, nor the doctor, nor you will know which group you are in. It is essential to mention that lactose tablets will have no effect.
The treatment consists of one tablet every 12 hours for 7 days and then one tablet every 24 hours at night until completing 83 days. We will perform a head CT scan upon admission, on day 2, and on day 90. We will also take blood samples for the laboratory (approximately two teaspoons of blood) on days 0 (upon admission), 5, 30, and 90 to measure substances in the blood that may be modified by the medication and confirm its protective effect on the brain. During your hospital stay, your treating physician will evaluate you daily, and we will perform evaluations on days 3 and 5. Once discharged, the patient will attend monthly medical follow-up appointments on days 30, 60, and 90 after the infarction.
The blood samples will be stored for later evaluation, within a period of fewer than 3 years, with the support of the Universidad Michoacana de San Nicolás de Hidalgo and the Centro de Investigación Biomédica de Michoacán. These samples may be used for future research if you authorize them.
If you decide to participate, you will take your medication according to the instructions. We will monitor you during your hospitalization, and you will attend monthly appointments on days 30, 60, and 90. During these appointments, we will perform clinical evaluations, administer questionnaires, conduct a CT scan, take blood samples, and provide melatonin or a placebo. Each appointment will require 60 minutes to perform all the interventions mentioned.
During your illness, you may experience complications specific to cerebral infarction, such as infections, ulcers, or cerebral hemorrhage, which will be addressed, and only in the case of a severe infection, you will be withdrawn from the study.
No travel expenses will be provided for follow-up appointments. BENEFITS AT THE END OF THE STUDY There will be no economic benefits for the patient participating in the study. At the end of the study, we will have gained more knowledge about the effect of melatonin on brain protection for patients with embolism, in order to offer another alternative in treatment that can decrease the complications caused by this disease. The administration of the medication is experimental and we hope that by receiving it, the patient may experience clinical improvement and a decrease in disability, although it is possible that it may not have any effect on the patient.
RISKS AND DISCOMFORT Melatonin has been shown to be a safe medication and is authorized for use in children and adults for the treatment of insomnia and disorders caused by changes in time zone due to travel or working night shifts. This study will evaluate the effectiveness of melatonin in the clinical development of the disease and its complications. By taking this medication, you may experience the following in order of frequency: drowsiness (28%), fatigue (25%), mood changes (16.7%), headache (13.3%), vomiting (13.3%), and hives (5%). If any of these symptoms occur, please contact us to determine the appropriate course of action, whether it be monitoring, treatment, hospitalization, or discontinuation of melatonin. In rare cases, you may experience increased activity, restlessness, decreased temperature, skin rash, insomnia, burping, tearing, fatigue, feeling heavy, nausea, decreased appetite, tiredness, or nighttime urinary incontinence. Again, if any of these symptoms occur, please contact us to determine the appropriate course of action.
The blood sample collection may cause slight pain from the needle and bruising at the puncture site. If these symptoms are not tolerable, please contact us at the phone numbers provided or go to the hospital's emergency department. You will also have an open appointment for emergency services when needed.
RESULTS INFORMATION AND TREATMENT ALTERNATIVES The complete results of this study will be available at the end of 2025 and will be sent to your registered email or phone number. You will be informed about the type of treatment received the results of your studies, as well as the results of the project. If a new treatment that improves your medical condition is discovered during the study, you will be informed immediately.
If any unforeseen events occur directly caused by the research, you will be treated at the IMSS or ISSSTE, depending on the institute you are registered with.
PARTICIPATION OR WITHDRAWAL Your participation is completely voluntary, and you may ask any questions you deem necessary at any time should you have any doubts. You may make the decision that you consider best, without this affecting your relationship with the IMSS or ISSSTE Institute (according to your registration). If you choose to participate in the study, you may leave the study at any time without affecting your care or relationship with the Institute or your doctor, and you may continue with your usual care and treatment.
If you decide to participate, you will have a contact person to stay in communication with the researcher whenever you deem it necessary.
If you choose not to participate, your relationship and care at the institute or with your doctor will not be affected, and you may continue with your usual care and treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A phase IIIb clinical trial, randomized double-blind, parallel
| Arm | Type | Receives |
|---|---|---|
| Melatonin group | Active comparator | Drug: Melatonin 10 MG, Other: PlaceboMelatonin group will receive prolonged released melatonin tablet 10mg for 7 days, then 10 mg for 83 days. |
| Placebo group | Placebo comparator | Drug: Melatonin 10 MG, Other: PlaceboPlacebo group will receive placebo tablet for 7 days, then for 83 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients presenting to the Emergency Department with acute ischemic CVD
- Affiliated to the IMSS and ISSSTE,
- Patients with NIHSS of 5-25 points
- Patients with an evolution of less than 24 hours,
- Patients over 18 years of age,
Key exclusion criteria (8 listed)
- Patients with cancer, rheumatic diseases, AIDS, immunological disease or conical infection, connective tissue diseases or CVD in the last 3 months,
- Pregnant patients, with renal or hepatic insufficiency, allergic to iodine
- Patients who receive thrombolytic
- Patient who were taking illicit drugs the following medicine: Imipramine, Thioridazine, Cyproterone, Teriflunomide, Abiraterone acetate, deferasirox, obeticholic acid, peginterferon α2b, vemurafenib.
- Patients who have an allergic reaction to melatonin
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 |
|---|---|---|
| Melatonin 10 MGAlso: CronocapsPatients received extended-release melatonin 10 mg PO every 12 hours for 7 days and then every 24 hours for 83 days | Drug | Melatonin group, Placebo group |
| PlaceboPatients received placebo every 12 hours for 7 days and then every 24 hours for 83 days | Other | Melatonin group, Placebo group |
Primary outcome
Change in functional outcome and mortality
Time frame: 3 months
Is considered improvement, if present a decrease of NIHSS of 10 points on day 30, Or if you have one rating of 0-1 points before the day 7, from the start of symptoms. Is considered deterioration if NIHSS increases more than 4 points the first 5 days of the stroke.
5 secondary outcomes
Change in infarct volume
Time frame: 3 months
Change in inflammatory biomarkers
Time frame: 7 days
Change in antiapoptotic biomarkers
Time frame: 7 days
Change in antioxidant biomarkers
Time frame: 3 months
Change endothelial damage
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- 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. This study is not recruiting at the moment.
Georgina Ortiz-Martínez, MC principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melatonin 10 MG in people with Stroke, Acute Ischemic and Strokes Thrombotic, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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 8 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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 Mexico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgina Ortiz Martínez (443120510, gortizm001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional outcome and mortality (time frame: 3 months). 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 5 Mar 2024.