AsthmaPhase 3MAGICIANNCT06785272
Magnesium Trial in Acute Asthma in Emergency Department
A Phase 3 study testing magnesium sulfate and Normal Saline in people with Asthma, run by Suzanne Schuh at 6 sites in Canada.
Trial summary
Despite optimal initial emergency department (ED) therapy, 50% of children with severe acute asthma have ongoing moderate-severe respiratory distress. Guidelines recommend intravenous magnesium (IVMg) for them, yet evidence for IVMg efficacy is scant and disparate. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- magnesium sulfate and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 6 sitesCanada
- Study dates
- 8 Oct 2025to Oct 2027
- Phase
- Phase 3
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2.00-17.99 years (prior to 18th birthday),
- Diagnosis of asthma, defined as an asthma or probable asthma diagnosis/asthma-like phenotype made by a physician (this includes ED physician) in a patient who in the opinion of the treating ED physician requires therapy for acute asthma in the ED (GINA asthma guidelines, 2024).
- Moderate-severe asthma after initial therapy with 3 treatments of inhaled salbutamol and ipratropium, defined as an eligibility PRAM ≥5, indicating a strong association with hospitalization.
Who cannot join
- Receipt of IVMg within 24 hours prior to ED arrival.
- Need for airway support on arrival. (Airway support on arrival meeting exclusion criteria will include immediate need for high flow nasal cannula therapy, non-invasive CPAP/bi-PAP ventilation or invasive ventilation with endotracheal intubation, as decided by the attending Emergency Department (ED) physician. Supplemental oxygen therapy will not represent an exclusion criterion.)
- Known renal, chronic pulmonary, neurologic, cardiac or systemic disease: these may influence outcomes after Mg.
- Known hypersensitivity to Mg sulfate.
- Previous enrollment.
- Poor mastery of English and/or French language precluding informed consent understanding.
- No phone/email; unavailable for follow-up
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Not yet recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Mohamed Eltorki, MD, mmeltork@ucalgary.ca
Stephen Freedman, MD, stephen.freedman@albertahealthservices.ca
- Not yet recruiting
Stollery Children's Hospital
Edmonton, Ontario, T6G 2B7
Sarah Curtis, MD, 4164423743, scurtis@ualberta.ca
Andrew Dixon, MD, andrew.dixon@albertahealthservices.ca
- Not yet recruiting
McMaster Children's Hospital
Hamilton, Ontario, L8S 4L8
April Kam, MD, kama@mcmaster.ca
Redjana Carciumaru, (289) 244-8652, carciur@mcmaster.ca
- Not yet recruiting
CHU-Sainte Justine Hospital
Montreal, Quebec, H3T 1C5
Jocelyn Gravel, MD, graveljocelyn@hotmail.com
Ramona Cook, BScN, ramona.cook@recherche-ste-justine.qc.ca
- Not yet recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Waleed Alqurashi, MD, walqurashi@cheo.on.ca
Candice McGahern, CMcGahern@cheo.on.ca
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Sunita O'Shea Project Manager, 416-813-7654 ext. 228453, sunita.oshea@sickkids.ca
Suzanne Schuh
About this study
Despite optimal initial emergency department (ED) therapy, 50% of children with severe acute asthma have ongoing moderate-severe respiratory distress. Guidelines recommend intravenous magnesium (IVMg) for them, yet evidence for IVMg efficacy is scant and disparate. While early small Randomized Controlled Trials (RCTs) suggested hospitalization benefit, recent large observational studies found no association between IVMg and improved outcomes. IVMg therapy is resource-intensive, can cause hypotension and demands close monitoring. Previous RCTs only assessed early Mg effect at 1-2 hours, overlooked the peak effect of key co-interventions such as corticosteroids and did not use validated scores. IVMg use is variable and often delayed until ≥4 hours after ED therapy is started and after the hospitalization decision has been made. Thus, in observational studies children given IVMg are 6-10 times more likely to be hospitalized; these studies have major confounding and the true IVMg treatment effect is thus unknown. To conclusively determine if IVMg alters the exacerbation course, it must be given early, and the primary outcome measure should be the severity of respiratory distress measured at the peak effect of key co-interventions to focus on a clinically meaningful and objective effect. The Pediatric Respiratory Assessment Measure (PRAM)-a valid, discriminative, reproducible and responsive-to-change instrument-is thus the ideal primary outcome measure. Hospitalization outcome has major confounding by indication and MD perceptions.
Primary Aim: In children with acute asthma remaining in moderate-severe distress after 1 hour of initial ED therapy, is early IVMg therapy associated with a significantly greater improvement in respiratory distress, measured by PRAM, at 2 hours after starting the intervention, compared to placebo? Hypothesis: IVMg will yield significantly greater PRAM improvement of ≥1.0 point than placebo.
Expected Outcomes: This trial will clarify if there is an incremental benefit of IVMg in decreasing respiratory distress in pediatric refractory acute asthma. A positive result will establish a proven standard of care for this indication, with a need for Knowledge Translation (KT) to implement routine early IVMg therapy. A negative result will lead to de-implementation of IVMg which may also lead to cost savings.
Read the detailed description
The investigators propose a 6-centre randomized, double-blind, placebo-controlled trial. Two groups will be compared: IV Mg sulfate and IV (intravenous) 0.9% saline placebo. After initial therapy with the systemic Corticosteroids (CSs) routinely used for acute asthma management at a given site, 3 treatments with inhaled salbutamol and ipratropium (ipratropium use as per local practice), eligible patients with PRAM ≥5 will, under the care of the research nurse, receive a 30-minute IV infusion of 75 mg/kg of Mg sulfate (maximum 2.0 g) [experimental group] or an identical volume of 0.9% saline [control group]. Outcomes will be measured during the 180-minute observational period in the ED and at 72 hours post ED discharge.
- Conditions
- Asthma
- Being tested
- magnesium sulfate, Normal Saline
- Keywords
- asthma, magnesium sulfate, pediatric, acute asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium sulfateDrug
After initial therapy with the systemic CSs routinely used for acute asthma management at a given site, 3 treatments with inhaled salbutamol and ipratropium, eligible patients with PRAM ≥5 will, under the care of the research nurse, receive a 30-minute IV infusion of 75 mg/kg of Mg sulfate(maximum 2.0 g) [experimental group]
Normal SalineDrug
After initial therapy with the systemic CSs routinely used for acute asthma management at a given site, 3 treatments with inhaled salbutamol and ipratropium, eligible patients with PRAM ≥5 will, under the care of the research nurse, receive a 30-minute IV infusion of 0.9% saline [control group].
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | This group will receive a single dose of intravenous magnesium sulfate over 30 minutes. After this treatment has been completed, they may also get further Ventolin inhalations or other asthma medicines which are not part of the study, as recommended by the emergency physician. The participant will be monitored closely by the study nurse who will measure their breathing, heart rate, blood pressure and oxygen for 3 hours after the study treatment. The study nurse will also notify the emergency physician of any major changes. Receives: Drug: magnesium sulfate |
| Placebo Group | Placebo comparator | This group, will receive a single dose of intravenous placebo (normal saline, i.e. salt water) over 30 minutes. After this treatment has been completed, they may also get further Ventolin inhalations or other asthma medicines which are not part of the study, as recommended by the emergency physician who is taking care of the participant. They will be monitored closely by the study nurse who will measure the participant's breathing, heart rate, blood pressure and oxygen for 3 hours after the study treatment. The study nurse will also notify the emergency physician of any major changes in their health. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Respiratory Assessment Measure (PRAM) score: This score ranges from 0-12. A score from 0-3 is mild, 4-7 moderate and 8-12 severe. A low score is a better outcome and a high score is a worse outcome.
PRAM is a validated 12-point asthma severity score which exhibits the most comprehensive measurement properties of all asthma scores and has been successfully used as an outcome in major trials. It is the only score with demonstrated criterion validity, using respiratory resistance as the gold standard. PRAM has been validated in both preschool and school-aged children in the ED with asthma and has strong association with admission. PRAM has inter-rater reliability above 70% and is adopted in all pediatric EDs in Canada. Most children treated for acute asthma are preschoolers who lack coordination to perform pulmonary function tests reliably. To maximize the accuracy of the PRAM measurement, all study nurses will complete an online PRAM training module. We will use an eligibility cut-off of PRAM ≥ 5 post initial therapy as this is associated with clinically concerning respiratory distress requiring further intervention. A PRAM score from 0-3 is mild, 4-7 moderate and 8-12 severe.
Measured: The primary outcome measure will be the PRAM score at 120 minutes post start of experimental therapy.
Secondary outcomes (9)
Changes in PRAM score
Changes in vital signs
Measured: Changes in PRAM score from baseline (pre intervention) to 30, 60, 120, 180 minutes after start of experimental therapy
Hospitalization for asthma at the index ED visit
Defined as admission to an inpatient unit due to continued/worsening distress
Measured: Up to 24 hours after starting experimental therapy
Changes in respiratory rate
Changes in vital signs
Measured: From baseline (pre-intervention) to 30,60,120 and 180 minutes post intervention (respiratory rate )
Changes in oxygen saturation
Changes in vital signs
Measured: From baseline (pre-intervention) to 30,60,120 and 180 minutes post intervention ( oxygen saturation)
Changes in blood pressure
Changes in vital signs
Measured: From baseline (pre-intervention) to 10,20,30,60,120, and 180 minutes post intervention (blood pressure).
PRAM denoting mild asthma (≤ 3 points is a widely accepted discharge criterion).
Pediatric Respiratory Assessment Measure (PRAM) is a valid clinical score assessing acute asthma severity in toddlers and teenages. Score ranges from 0 to 12 (mild to severe). A higher score is a more severe asthma measurement. A low score is a better outcome than a high score.
Measured: at 120 minutes post intervention
Hospitalization for asthma at any medical facility
Defined as admission to an inpatient unit due to continued/worsening distress
Measured: within 72 hours post- ED discharge
Unscheduled asthma-related visits to any health care provider
Family-initiated asthma-related medical visit
Measured: within 72 hours post- ED discharge
Hospital length of stay.
Length of stay is the duration of a hospital stay in hours
Measured: From presentation at the Emergency Department triage to the time of hospital discharge, up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start8 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzanne Schuh
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Children's Hospital, McMaster Children's Hospital, Stollery Children's Hospital, Children's Hospital of Eastern Ontario, St. Justine's Hospital, The Hospital for Sick Children
- Responsible party
- Sponsor-investigator, Suzanne Schuh, The Hospital for Sick Children
- Investigators
- Suzanne Schuh, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785272
- Sponsor's protocol ID
- 5274
- Acronym
- MAGICIAN
- Status last verified
- Oct 2025
- First submitted
- 9 Jan 2025
- Last updated
- 18 Dec 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Trial in Acute Asthma in Emergency Department
- ClinicalTrials.gov ID
- NCT06785272
- Acronym / sponsor ID
- MAGICIAN / 5274
- Conditions
- Asthma
- Keywords
- asthma, magnesium sulfate, pediatric, acute asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Suzanne SchuhUniversity, hospital or other
- Collaborators
- Alberta Children's Hospital, McMaster Children's Hospital, Stollery Children's Hospital, Children's Hospital of Eastern Ontario, St. Justine's Hospital, The Hospital for Sick Children
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite optimal initial emergency department (ED) therapy, 50% of children with severe acute asthma have ongoing moderate-severe respiratory distress. Guidelines recommend intravenous magnesium (IVMg) for them, yet evidence for IVMg efficacy is scant and disparate. While early small Randomized Controlled Trials (RCTs) suggested hospitalization benefit, recent large observational studies found no association between IVMg and improved outcomes. IVMg therapy is resource-intensive, can cause hypotension and demands close monitoring. Previous RCTs only assessed early Mg effect at 1-2 hours, overlooked the peak effect of key co-interventions such as corticosteroids and did not use validated scores. IVMg use is variable and often delayed until ≥4 hours after ED therapy is started and after the hospitalization decision has been made. Thus, in observational studies children given IVMg are 6-10 times more likely to be hospitalized; these studies have major confounding and the true IVMg treatment effect is thus unknown. To conclusively determine if IVMg alters the exacerbation course, it must be given early, and the primary outcome measure should be the severity of respiratory distress measured at the peak effect of key co-interventions to focus on a clinically meaningful and objective effect. The Pediatric Respiratory Assessment Measure (PRAM)-a valid, discriminative, reproducible and responsive-to-change instrument-is thus the ideal primary outcome measure. Hospitalization outcome has major confounding by indication and MD perceptions.
Primary Aim: In children with acute asthma remaining in moderate-severe distress after 1 hour of initial ED therapy, is early IVMg therapy associated with a significantly greater improvement in respiratory distress, measured by PRAM, at 2 hours after starting the intervention, compared to placebo? Hypothesis: IVMg will yield significantly greater PRAM improvement of ≥1.0 point than placebo.
Expected Outcomes: This trial will clarify if there is an incremental benefit of IVMg in decreasing respiratory distress in pediatric refractory acute asthma. A positive result will establish a proven standard of care for this indication, with a need for Knowledge Translation (KT) to implement routine early IVMg therapy. A negative result will lead to de-implementation of IVMg which may also lead to cost savings.
Detailed description
The investigators propose a 6-centre randomized, double-blind, placebo-controlled trial. Two groups will be compared: IV Mg sulfate and IV (intravenous) 0.9% saline placebo. After initial therapy with the systemic Corticosteroids (CSs) routinely used for acute asthma management at a given site, 3 treatments with inhaled salbutamol and ipratropium (ipratropium use as per local practice), eligible patients with PRAM ≥5 will, under the care of the research nurse, receive a 30-minute IV infusion of 75 mg/kg of Mg sulfate (maximum 2.0 g) [experimental group] or an identical volume of 0.9% saline [control group]. Outcomes will be measured during the 180-minute observational period in the ED and at 72 hours post ED discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: magnesium sulfateThis group will receive a single dose of intravenous magnesium sulfate over 30 minutes. After this treatment has been completed, they may also get further Ventolin inhalations or other asthma medicines which are not part of the study, as recommended by the emergency physician. The participant will be monitored closely by the study nurse who will measure their breathing, heart rate, blood pressure and oxygen for 3 hours after the study treatment. The study nurse will also notify the emergency physician of any major changes. |
| Placebo Group | Placebo comparator | Drug: Normal SalineThis group, will receive a single dose of intravenous placebo (normal saline, i.e. salt water) over 30 minutes. After this treatment has been completed, they may also get further Ventolin inhalations or other asthma medicines which are not part of the study, as recommended by the emergency physician who is taking care of the participant. They will be monitored closely by the study nurse who will measure the participant's breathing, heart rate, blood pressure and oxygen for 3 hours after the study treatment. The study nurse will also notify the emergency physician of any major changes in their health. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 2.00-17.99 years (prior to 18th birthday),
- Diagnosis of asthma, defined as an asthma or probable asthma diagnosis/asthma-like phenotype made by a physician (this includes ED physician) in a patient who in the opinion of the treating ED physician requires therapy for acute asthma in the ED (GINA asthma guidelines, 2024).
- Moderate-severe asthma after initial therapy with 3 treatments of inhaled salbutamol and ipratropium, defined as an eligibility PRAM ≥5, indicating a strong association with hospitalization.
Key exclusion criteria (7 listed)
- Receipt of IVMg within 24 hours prior to ED arrival.
- Need for airway support on arrival. (Airway support on arrival meeting exclusion criteria will include immediate need for high flow nasal cannula therapy, non-invasive CPAP/bi-PAP ventilation or invasive ventilation with endotracheal intubation, as decided by the attending Emergency Department (ED) physician. Supplemental oxygen therapy will not represent an exclusion criterion.)
- Known renal, chronic pulmonary, neurologic, cardiac or systemic disease: these may influence outcomes after Mg.
- Known hypersensitivity to Mg sulfate.
- Previous enrollment.
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 |
|---|---|---|
| magnesium sulfateAfter initial therapy with the systemic CSs routinely used for acute asthma management at a given site, 3 treatments with inhaled salbutamol and ipratropium, eligible patients with PRAM ≥5 will, under the care of the research nurse, receive a 30-minute IV infusion of 75 mg/kg of Mg sulfate(maximum 2.0 g) [experimental group] | Drug | Experimental Group |
| Normal SalineAfter initial therapy with the systemic CSs routinely used for acute asthma management at a given site, 3 treatments with inhaled salbutamol and ipratropium, eligible patients with PRAM ≥5 will, under the care of the research nurse, receive a 30-minute IV infusion of 0.9% saline [control group]. | Drug | Placebo Group |
Primary outcome
Pediatric Respiratory Assessment Measure (PRAM) score: This score ranges from 0-12. A score from 0-3 is mild, 4-7 moderate and 8-12 severe. A low score is a better outcome and a high score is a worse outcome.
Time frame: The primary outcome measure will be the PRAM score at 120 minutes post start of experimental therapy.
PRAM is a validated 12-point asthma severity score which exhibits the most comprehensive measurement properties of all asthma scores and has been successfully used as an outcome in major trials. It is the only score with demonstrated criterion validity, using respiratory resistance as the gold standard. PRAM has been validated in both preschool and school-aged children in the ED with asthma and has strong association with admission. PRAM has inter-rater reliability above 70% and is adopted in all pediatric EDs in Canada. Most children treated for acute asthma are preschoolers who lack coordination to perform pulmonary function tests reliably. To maximize the accuracy of the PRAM measurement, all study nurses will complete an online PRAM training module. We will use an eligibility cut-off of PRAM ≥ 5 post initial therapy as this is associated with clinically concerning respiratory distress requiring further intervention. A PRAM score from 0-3 is mild, 4-7 moderate and 8-12 severe.
9 secondary outcomes
Changes in PRAM score
Time frame: Changes in PRAM score from baseline (pre intervention) to 30, 60, 120, 180 minutes after start of experimental therapy
Hospitalization for asthma at the index ED visit
Time frame: Up to 24 hours after starting experimental therapy
Changes in respiratory rate
Time frame: From baseline (pre-intervention) to 30,60,120 and 180 minutes post intervention (respiratory rate )
Changes in oxygen saturation
Time frame: From baseline (pre-intervention) to 30,60,120 and 180 minutes post intervention ( oxygen saturation)
Changes in blood pressure
Time frame: From baseline (pre-intervention) to 10,20,30,60,120, and 180 minutes post intervention (blood pressure).
PRAM denoting mild asthma (≤ 3 points is a widely accepted discharge criterion).
Time frame: at 120 minutes post intervention
Hospitalization for asthma at any medical facility
Time frame: within 72 hours post- ED discharge
Unscheduled asthma-related visits to any health care provider
Time frame: within 72 hours post- ED discharge
Hospital length of stay.
Time frame: From presentation at the Emergency Department triage to the time of hospital discharge, up to 4 weeks.
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 18 Dec 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.
Suzanne Schuh, MD principal investigator
The Hospital for Sick Children
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing magnesium sulfate and Normal Saline in people with Asthma, run by Suzanne Schuh at 6 sites 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 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?
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 Sunita O'Shea (416-813-7654 ext. 228453, sunita.oshea@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Respiratory Assessment Measure (PRAM) score: This score ranges from 0-12. A score from 0-3 is mild, 4-7 moderate and 8-12 severe. A low score is a better outcome and a high score is a worse outcome. (time frame: The primary outcome measure will be the PRAM score at 120 minutes post start of experimental therapy.). 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 18 Dec 2025.