Neuromuscular ScoliosisPhase 4NCT06023043
Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients
A Phase 4 study testing Dexamethasone in people with Neuromuscular Scoliosis and Adolescent Idiopathic Scoliosis, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The goal of this randomized clinical trial is to compare the immediate use of steroids after surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular scoliosis after a posterior spinal fusion. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Neuromuscular Scoliosis, Adolescent Idiopathic Scoliosis
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 31 Dec 2028
- Phase
- Phase 4
- 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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants must meet all of the inclusion criteria to participate in this study:
- Patients aged 9-18 years who are scheduled to undergo posterior spinal fusion to treat AIS or NMS
Who cannot join
- Patients will be excluded if any of the following criteria are met at baseline:
- Prior instrumentation or spine surgery
- Conditions associated with increased wound healing issues such as spina bifida
- Non AIS or NMS patients
- Not undergoing PSF
- Outside the ages of 9-18
Show all 9Show fewer
- Allergies to the steroids and/or their ingredients
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tiffany Phan, BA contact
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
Tiffany Phan, 3108488377, tphan@chla.usc.edu
Lindsay Andras, MD
About this study
Official title: A Randomized Trial of Postoperative Steroid Use Following Posterior Spinal Fusion in 100-subject Adolescent Idiopathic Scoliosis (AIS) and Neuromuscular Scoliosis (NMS)
The goal of this randomized clinical trial is to compare the immediate use of steroids after surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular scoliosis after a posterior spinal fusion.
The main question it aims to answer are:
Read more
- What are the effects of using steroids immediately after surgery in decreasing opioid use and helping early mobilization(movement)?
- Does post-operative steroid use affect the incidence of wound complications and are there any long-term impacts on scar formation?
Participants will:
- Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey specifically for pain interference and physical activity observing health related quality of life at enrollment, 3 months, 1 year, and 2 years
- Have clinical photos of their incision at 3 months, 1 year, and 2 years
- Their photos will be assessed using the stony book scar evaluation scale
- For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF) per standard of care, however whether the participant receives or does not receive steroids is what the investigators are trying to understand.
- Researchers will compare no immediate postoperative steroid (NS) to the group with immediate postoperative steroid (WS) group to see if there are changes in opioid use, wound complications, scar formation, and facilitation in early mobilization.
Read the detailed description
Children remain a vulnerable population historically known to be undertreated and underrecognized for their pain, only perpetuating the complexity of managing pain control in this cohort. Children's Hospital of Los Angeles conducted a study observing patient and family's perioperative perception regarding their posterior spinal fusion and found that pain control is a primary concern, however, surgeons did not share the sentiment. Opioids were primarily the medication of choice with dentists and surgeons accounting for approximately two-thirds of opioid prescriptions. However, with the rise of the national opioid crisis and its adverse effects not limited to addiction, providers are gravitating towards alternative multidisciplinary use of medication to manage pain.
Though steroids were formerly used for surgical patients, concerns regarding increased surgical site infection and wound healing complications were of major concern. However, to the investigators knowledge, these issues have only been documented with chronic steroid use. The impact of immediate use of steroids postoperatively for accelerated discharge has gained momentum in the literature with its demonstration in facilitating earlier mobility, decreased pain scores, and decreased narcotic usage. A retrospective study suggested that post-operative dexamethasone administration can have the positive effect of reducing opioid use in pediatric PSF patients without increasing wound complications.
The proposed study aims to rigorously observe the effects of post operative steroid use in its facilitation in early mobilization in adolescent PSF patients, while also understanding the incidence of wound complications and long-term scar formation. Should the randomized controlled trial align with the literature, the implementation of post-operative steroids could potentially alter standard of care for adolescent PSF patients.
- Being tested
- Dexamethasone
- Keywords
- Steroid, Dexamethasone, Scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Three (3) post operative intravenous dexamethasone injections at 8-hour intervals post-operatively. Dosing will be determined as 0.15 mg/kg per dose (WS)
| Study group | Role | What they receive |
|---|---|---|
| No Steroid (NS) | No intervention | No Dexamethasone (NS) |
| With Steroid (WS) | Experimental | With Dexamethasone (WS) Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Day/hours to discharge from hospital following completion of surgery.
Measured: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Post Operative Opioid Use
Expressed as morphine milligram equivalent (MME, mg) units and weight-based MME (mg/kg)
Measured: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Secondary outcomes (7)
Post Operative Ambulation (for ambulatory patients)
Will obtain number of feet ambulated with physical therapy (PT) staff on each post operative day. Will record number of days postoperatively until PT clearance for discharge.
Measured: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Return of Bowel Function
Will record time to return of bowel sounds as noted by nursing or house staff. Will record time to first bowel movement.
Measured: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Rate of wound complications requiring intervention
3.1) Additional clinic visits for drainage or wound concerns will be recorded. 3.2) Use of antibiotic for superficial wound issues will be recorded. 3.3) Any additional operative intervention or hospitalization for concern/management of an infection.
Measured: Less than 90 days from hospitalization
Scar Appearance
Clinical photos will be obtained and graded with Stony Brook Scar Evaluation Scale.
The Stony Brook Scar evaluation scale ranges from a minimum value of 0 (worst) to a maximum value of 5 (best).
Measured: Immediately from enrollment through study completion, at an average of 2 years
Patient-Reported Outcomes Measurement Information System (PROMIS)
The Patient-Reported Outcomes Measurement Information System is a validated quality of life and outcome questionnaire used for various studies. This will also be completed by the parent, if the patient is unable to do so.
PROMIS domains that will be utilized include:
- pain interference
- A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used.
- A higher score is indicative of more problems with pain hindering activities than a lower score.
- physical activity
- A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used.
- A higher score is indicative of engagement with more physical activities than a lower score.
- mobility
- A five-point Likert scale ranging from 1 ("never") to 5 ("almost always") is used.
- A higher score is indicative of engagement with more mobility than a lower score.
Measured: Immediately from enrollment through study completion, at an average of 2 years
Post-Operative Complications
Any additional emergency room visits/readmission or revision surgery
Measured: Within 2 years from date of surgery.
Body Mass Index
Weight, measured in kilograms, and height, measured in meters, will be combined to report body mass index in kg/m^2
Measured: Immediately from enrollment through study completion, at an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Nov 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular ScoliosisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Andras, Children's Hospital Los Angeles
- Investigators
- Lindsay Andras, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023043
- Sponsor's protocol ID
- CHLA-23-00124
- Status last verified
- Mar 2025
- First submitted
- 8 Aug 2023
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fletcher ND, Shourbaji N, Mitchell PM, Oswald TS, Devito DP, Bruce RW. Clinical and economic implications of early discharge following posterior spinal fusion for adolescent idiopathic scoliosis. J Child Orthop. 2014 May;8(3):257-63. doi: 10.1007/s11832-014-0587-y. Epub 2014 Apr 27.
PubMed 24770995Gornitzky AL, Flynn JM, Muhly WT, Sankar WN. A Rapid Recovery Pathway for Adolescent Idiopathic Scoliosis That Improves Pain Control and Reduces Time to Inpatient Recovery After Posterior Spinal Fusion. Spine Deform. 2016 Jul;4(4):288-295. doi: 10.1016/j.jspd.2016.01.001. Epub 2016 Jun 16.
PubMed 27927519Keohane D, Sheridan G, Harty J. Perioperative steroid administration improves knee function and reduces opioid consumption in bilateral total knee arthroplasty. J Orthop. 2020 Oct 7;22:449-453. doi: 10.1016/j.jor.2020.10.004. eCollection 2020 Nov-Dec.
PubMed 33093753Fletcher ND, Ruska T, Austin TM, Guisse NF, Murphy JS, Bruce RW Jr. Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. J Bone Joint Surg Am. 2020 Oct 21;102(20):1807-1813. doi: 10.2106/JBJS.20.00259.
PubMed 33086348Birnie KA, Chambers CT, Fernandez CV, Forgeron PA, Latimer MA, McGrath PJ, Cummings EA, Finley GA. Hospitalized children continue to report undertreated and preventable pain. Pain Res Manag. 2014 Jul-Aug;19(4):198-204. doi: 10.1155/2014/614784. Epub 2014 May 7.
PubMed 24809068Friedrichsdorf SJ, Postier A, Eull D, Weidner C, Foster L, Gilbert M, Campbell F. Pain Outcomes in a US Children's Hospital: A Prospective Cross-Sectional Survey. Hosp Pediatr. 2015 Jan;5(1):18-26. doi: 10.1542/hpeds.2014-0084.
PubMed 25554755Gonzalez L. Pediatric Opioid Prescribing: A Call for Calm. Pediatrics. 2021 Sep;148(3):e2021052190. doi: 10.1542/peds.2021-052190. Epub 2021 Aug 16. No abstract available.
PubMed 34400573Singla A, Qureshi R, Chen DQ, Nourbakhsh A, Hassanzadeh H, Shimer AL, Shen FH. Risk of Surgical Site Infection and Mortality Following Lumbar Fusion Surgery in Patients With Chronic Steroid Usage and Chronic Methicillin-Resistant Staphylococcus aureus Infection. Spine (Phila Pa 1976). 2019 Apr 1;44(7):E408-E413. doi: 10.1097/BRS.0000000000002864.
PubMed 30889145Chan P, Skaggs DL, Sanders AE, Villamor GA, Choi PD, Tolo VT, Andras LM. Pain is the Greatest Preoperative Concern for Patients and Parents Before Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2017 Nov 1;42(21):E1245-E1250. doi: 10.1097/BRS.0000000000002147.
PubMed 28263228
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Postoperative Steroid Use Following Posterior Spinal Fusion in 100-subject Adolescent Idiopathic Scoliosis (AIS) and Neuromuscular Scoliosis (NMS)
- ClinicalTrials.gov ID
- NCT06023043
- Acronym / sponsor ID
- CHLA-23-00124
- Keywords
- Steroid, Dexamethasone, Scoliosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Sep 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.
The goal of this randomized clinical trial is to compare the immediate use of steroids after surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular scoliosis after a posterior spinal fusion.
The main question it aims to answer are:
- What are the effects of using steroids immediately after surgery in decreasing opioid use and helping early mobilization(movement)?
- Does post-operative steroid use affect the incidence of wound complications and are there any long-term impacts on scar formation?
Participants will:
- Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey specifically for pain interference and physical activity observing health related quality of life at enrollment, 3 months, 1 year, and 2 years
- Have clinical photos of their incision at 3 months, 1 year, and 2 years
- Their photos will be assessed using the stony book scar evaluation scale
- For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF) per standard of care, however whether the participant receives or does not receive steroids is what the investigators are trying to understand.
- Researchers will compare no immediate postoperative steroid (NS) to the group with immediate postoperative steroid (WS) group to see if there are changes in opioid use, wound complications, scar formation, and facilitation in early mobilization.
Detailed description
Children remain a vulnerable population historically known to be undertreated and underrecognized for their pain, only perpetuating the complexity of managing pain control in this cohort. Children's Hospital of Los Angeles conducted a study observing patient and family's perioperative perception regarding their posterior spinal fusion and found that pain control is a primary concern, however, surgeons did not share the sentiment. Opioids were primarily the medication of choice with dentists and surgeons accounting for approximately two-thirds of opioid prescriptions. However, with the rise of the national opioid crisis and its adverse effects not limited to addiction, providers are gravitating towards alternative multidisciplinary use of medication to manage pain.
Though steroids were formerly used for surgical patients, concerns regarding increased surgical site infection and wound healing complications were of major concern. However, to the investigators knowledge, these issues have only been documented with chronic steroid use. The impact of immediate use of steroids postoperatively for accelerated discharge has gained momentum in the literature with its demonstration in facilitating earlier mobility, decreased pain scores, and decreased narcotic usage. A retrospective study suggested that post-operative dexamethasone administration can have the positive effect of reducing opioid use in pediatric PSF patients without increasing wound complications.
The proposed study aims to rigorously observe the effects of post operative steroid use in its facilitation in early mobilization in adolescent PSF patients, while also understanding the incidence of wound complications and long-term scar formation. Should the randomized controlled trial align with the literature, the implementation of post-operative steroids could potentially alter standard of care for adolescent PSF patients.
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 |
|---|---|---|
| No Steroid (NS) | No intervention | –No Dexamethasone (NS) |
| With Steroid (WS) | Experimental | Drug: DexamethasoneWith Dexamethasone (WS) |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients aged 9-18 years who are scheduled to undergo posterior spinal fusion to treat AIS or NMS
Key exclusion criteria (9 listed)
- Prior instrumentation or spine surgery
- Conditions associated with increased wound healing issues such as spina bifida
- Non AIS or NMS patients
- Not undergoing PSF
- Outside the ages of 9-18
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 |
|---|---|---|
| DexamethasoneThree (3) post operative intravenous dexamethasone injections at 8-hour intervals post-operatively. Dosing will be determined as 0.15 mg/kg per dose (WS) | Drug | With Steroid (WS) |
Primary outcome
Length of Stay
Time frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Day/hours to discharge from hospital following completion of surgery.
Post Operative Opioid Use
Time frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Expressed as morphine milligram equivalent (MME, mg) units and weight-based MME (mg/kg)
7 secondary outcomes
Post Operative Ambulation (for ambulatory patients)
Time frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Return of Bowel Function
Time frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks
Rate of wound complications requiring intervention
Time frame: Less than 90 days from hospitalization
Scar Appearance
Time frame: Immediately from enrollment through study completion, at an average of 2 years
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: Immediately from enrollment through study completion, at an average of 2 years
Post-Operative Complications
Time frame: Within 2 years from date of surgery.
Body Mass Index
Time frame: Immediately from enrollment through study completion, at an average of 2 years
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 5 Mar 2025.
- Background: PubMed 24770995Fletcher ND, Shourbaji N, Mitchell PM, Oswald TS, Devito DP, Bruce RW. Clinical and economic implications of early discharge following posterior spinal fusion for adolescent idiopathic scoliosis. J Child Orthop. 2014 May;8(3):257-63. doi: 10.1007/s11832-014-0587-y. Epub 2014 Apr 27.
- Background: PubMed 27927519Gornitzky AL, Flynn JM, Muhly WT, Sankar WN. A Rapid Recovery Pathway for Adolescent Idiopathic Scoliosis That Improves Pain Control and Reduces Time to Inpatient Recovery After Posterior Spinal Fusion. Spine Deform. 2016 Jul;4(4):288-295. doi: 10.1016/j.jspd.2016.01.001. Epub 2016 Jun 16.
- Background: PubMed 33093753Keohane D, Sheridan G, Harty J. Perioperative steroid administration improves knee function and reduces opioid consumption in bilateral total knee arthroplasty. J Orthop. 2020 Oct 7;22:449-453. doi: 10.1016/j.jor.2020.10.004. eCollection 2020 Nov-Dec.
- Background: PubMed 33086348Fletcher ND, Ruska T, Austin TM, Guisse NF, Murphy JS, Bruce RW Jr. Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. J Bone Joint Surg Am. 2020 Oct 21;102(20):1807-1813. doi: 10.2106/JBJS.20.00259.
- Background: PubMed 24809068Birnie KA, Chambers CT, Fernandez CV, Forgeron PA, Latimer MA, McGrath PJ, Cummings EA, Finley GA. Hospitalized children continue to report undertreated and preventable pain. Pain Res Manag. 2014 Jul-Aug;19(4):198-204. doi: 10.1155/2014/614784. Epub 2014 May 7.
- Background: PubMed 25554755Friedrichsdorf SJ, Postier A, Eull D, Weidner C, Foster L, Gilbert M, Campbell F. Pain Outcomes in a US Children's Hospital: A Prospective Cross-Sectional Survey. Hosp Pediatr. 2015 Jan;5(1):18-26. doi: 10.1542/hpeds.2014-0084.
- Background: PubMed 34400573Gonzalez L. Pediatric Opioid Prescribing: A Call for Calm. Pediatrics. 2021 Sep;148(3):e2021052190. doi: 10.1542/peds.2021-052190. Epub 2021 Aug 16. No abstract available.
- Background: PubMed 30889145Singla A, Qureshi R, Chen DQ, Nourbakhsh A, Hassanzadeh H, Shimer AL, Shen FH. Risk of Surgical Site Infection and Mortality Following Lumbar Fusion Surgery in Patients With Chronic Steroid Usage and Chronic Methicillin-Resistant Staphylococcus aureus Infection. Spine (Phila Pa 1976). 2019 Apr 1;44(7):E408-E413. doi: 10.1097/BRS.0000000000002864.
- Background: PubMed 28263228Chan P, Skaggs DL, Sanders AE, Villamor GA, Choi PD, Tolo VT, Andras LM. Pain is the Greatest Preoperative Concern for Patients and Parents Before Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. Spine (Phila Pa 1976). 2017 Nov 1;42(21):E1245-E1250. doi: 10.1097/BRS.0000000000002147.
- 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.
Tiffany Phan, BA contact
Lindsay Andras, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Neuromuscular Scoliosis and Adolescent Idiopathic Scoliosis, run by Children's Hospital Los Angeles at 1 site in United States.
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 2 inclusion and 9 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 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Lindsay M Andras, MD (323-361-2142, landras@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (time frame: From date of hospitalization for surgery until date of first discharge, assessed up to two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06023043, which also lists 9 linked publications.
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 2025.