Neurogenic Detrusor OveractivityPhase 3NCT05621616
A Study to Learn How Effective and Safe the Drug 'Mirabegron' is and How Long it Stays in the Body of Children Aged 6 Months to Less Than 3 Years of Age With Neurogenic Detrusor Overactivity
A Phase 3 study testing mirabegron in people with Neurogenic Detrusor Overactivity, run by Astellas Pharma Global Development, Inc. at 3 sites in 2 countries.
Trial summary
People with neurogenic detrusor overactivity (NDO) have poor bladder control because of how their nerves to the bladder are wired. This can cause high pressure in the bladder, causing it to leak urine by accident (incontinence). Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Neurogenic Detrusor Overactivity
- What is being tested?
- mirabegron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 28 Feb 2024to 17 Sep 2026
- 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 6 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant's weight is a minimum of 9 kg.
- Participant has a previous myelomeningocele (documented at the screening visit).
- Participant has a diagnosis of neurogenic detrusor overactivity (NDO) confirmed by urodynamic investigation at baseline (day 1). The diagnosis of NDO should be confirmed by the presence of ≥ 1 involuntary detrusor contraction > 15 cm H2O from baseline detrusor pressure, and/or a decrease in bladder compliance leading to an increase in baseline detrusor pressure of > 20 cm H2O.
- Participant has a diagnosis of detrusor sphincter dyssynergia (DSD).
- Participant is using clean intermittent catheterization (CIC).
- Participant is suitable for a regimen of 4 to 6 CICs per day, fixed for the duration of the study using the 7-day baseline e-diary.
Show all 9Show fewer
- Participant is able to swallow the study drug.
- Participant's legally authorized representative (LAR) is willing and able to comply with the study requirements (including compliant use of the e-diary) and with the concomitant medication restrictions.
- Participant's LAR agree not to allow participant to participate in another interventional study while receiving study intervention and throughout the pretreatment period.
Who cannot join
- Participant has a bladder capacity less than 25% of expected age-related capacity, confirmed by urodynamic investigation at baseline (day 1).
- Participant has vesicoureteral reflux grade 3 to 5.
- Participant has a known genitourinary condition, other than NDO, that may cause overactive contractions and/or incontinence (e.g., bladder exstrophy, urinary tract obstruction, urethral diverticulum or fistula) or kidney/bladder stones or another persistent local pathology that may cause urinary symptoms.
- Participant has had an indwelling urinary catheter within 4 weeks prior to the baseline visit.
- Participant has undergone bladder augmentation surgery.
- Participant with surgically corrected underactive sphincter.
Show all 25Show fewer
- Participant receives electrostimulation therapy, if started within 30 days before visit 1 screening or is expected to start during the study period. Participants who are on an established regimen (defined as starting more than 30 days before visit 1 screening) may remain on this for the duration of the study.
- Participant has been administered intravesical botulinum toxin; except if given > 4 months prior to visit 1 screening and the participant experiences symptoms comparable to those existing prior to the botulinum toxin injections.
- Participant has a current symptomatic urinary tract infection (UTI) confirmed by urinalysis (urine culture containing > 100,000 cfu/mL) at baseline. If at screening and start of washout a UTI is present, the participant will be eligible for enrollment if the UTI has been treated successfully prior to baseline. If a symptomatic UTI is present at baseline, all baseline assessments should be postponed for a maximum of 7 days until the UTI is successfully treated. Successful treatment is defined as a symptom free patient with a white blood cell count in the urine < 100/microliter and urine culture below 100,000 cfu/mL.
- Participant is using prohibited medications.
- Participant has a diagnosis of central or congenital nephrogenic diabetes insipidus.
- Participant with severe gastrointestinal (GI) condition (including toxic megacolon) or any of the following GI conditions: partial or complete obstruction, decreased motility like paralytic ileus or at risk for gastric retention.
- Participant suffers from malnutrition or is severely overweight.
- Participant has an average QT interval corrected by Bazett's formula (QTcB) > 440 ms (based on the QTcB mean from the screening and baseline ECG triplicates), history of QTc prolongation or risk of QT prolongation (e.g., hypokalemia, Long QT Syndrome (LQTS), or family history of LQTS, exercise induced syncope).
- Participant has severe renal impairment (estimated glomerular filtration rate (eGFR) < 30 mL/min per 1.73 m^2 for participants 1 year of age and older; serum creatinine ≥ 2 × ULN, with ULN defined as 97.5th percentile for participants 6 to < 12 months of age.).
- Participant's aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is ≥ 2 × upper limit of normal (ULN) or total bilirubin (TBL) greater than or equal to 1.5 × ULN.
- Participant has a current or previous history of epilepsy.
- Participant has a history or presence of any malignancy prior to visit 1 screening.
- Participant has any other clinically significant out of range results of urinalysis, biochemistry, hematology or coagulation.
- Participant has an established hypertension and systolic or diastolic blood pressure greater than the 99th percentile of their normal range determined by gender, body size and age, plus 5 mmHg.
- Participant has a (median) resting heart rate > 99th percentile.
- Participant has any clinically significant or unstable medical condition or disorder which precludes the participant from participating in the study.
- Participant has known or suspected hypersensitivity to mirabegron, any of the excipients used in the current formulation or previous severe hypersensitivity to any drug.
- Participant has participated in another clinical trial and/or has taken an investigational drug within 30 days (or 5 half-lives of the drug, or the limit set by national law, whichever is longer) prior to visit 1 screening.
- Participant is being breast-fed by a woman taking any prohibited medication or fed with a milk product in which the presence of prohibited medication ingredients cannot be excluded.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: A Phase 3, Open Label, Multicenter, Baseline-Controlled Sequential Dose Titration Study Followed by a Fixed Dose Observation Period to Evaluate Pharmacokinetics, Efficacy and Safety of Mirabegron Prolonged-Release Microgranula-Based Suspension in Children From 6 Months to Less Than 3 Years of Age With Neurogenic Detrusor Overactivity
People with neurogenic detrusor overactivity (NDO) have poor bladder control because of how their nerves to the bladder are wired. This can cause high pressure in the bladder, causing it to leak urine by accident (incontinence). Mirabegron has already been approved for adults with bladder problems and for children 3 years and older. This study will learn if mirabegron can help young children with NDO. The children will be from 6 months to up to 3 years old.
The main aim of this study is to learn if mirabegron increases how much urine the bladder holds (maximum cystometric capacity, or Maximum Cystometric Capacity [MCC]) in young children with NDO. An increase in MCC will prevent high pressure in the bladder.
Read more
Children from 6 months to up to 3 years old who have NDO can take part. They must weigh 9 kilograms (kg) or more. They will already be fitted with a tube (catheter) in their bladder. They will use this to drain urine from their bladder regularly during the day. This is called clean intermittent catheterization (CIC).
There will be 2 groups in the study. Young children who aren't taking certain medicines for NDO will be in group A. Young children who are taking certain medicines for NDO will be in group B. Children in group B will stop taking these medicines before they start taking mirabegron. Treatment in group B will be delayed to allow the medicines to be cleared from the body before they start taking mirabegron. Both groups (A and B) will have the same treatment and dose of mirabegron and will have the same checks throughout the study.
Mirabegron will be squirted from a syringe into the children's mouths, followed by a sip of water. This will happen once a day for up to 52 weeks (1 year). They will start on a low dose, adjusted for their weight. The dose may be increased to a higher dose if the study doctor thinks the child will benefit from the higher dose.
Children will have safety checks throughout the study. Other tests will include checking how the bladder fills and empties plus an ultrasound of the bladder area.
There will be several clinic visits during the study. There will be fewer clinic visits if a child stays on the low dose of mirabegron. Then, the clinic will phone the caregiver about 1 month after the last dose of mirabegron to check if there are any further medical problems.
- Conditions
- Neurogenic Detrusor Overactivity
- Being tested
- mirabegron
- Keywords
- Neurogenic Detrusor Overactivity, Pediatric acceptability, Bladder capacity, Pharmacokinetics of mirabegron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirabegronDrug
Also called Betanis, Betmiga, Myrbetriq, YM178
Participants will receive mirabegron prolonged-release microgranula-based oral suspension once daily. The initial dose of mirabegron will be based on the participant's weight.
The initial low dose will be up-titrated to a higher dose at weeks 2, 4 or 8 unless the participant is determined to be effectively treated with the low dose, based on urodynamics and the participants'e-diary.
| Study group | Role | What they receive |
|---|---|---|
| mirabegron | Experimental | Participants will receive mirabegron prolonged-release microgranula-based oral suspension. Receives: Drug: mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
MCC is maximum bladder capacity reached at end of filling cytometry.
Measured: Baseline and week 24
Secondary outcomes (20)
Change from baseline in bladder compliance
Bladder compliance is calculated by change in volume divided by change in pressure during filling of the bladder.
Measured: Baseline and weeks 4 and 24
Change from baseline in filling volume until first detrusor contraction (>15cm H2O)
Change in bladder volume calculated by urodynamic assessments.
Measured: Baseline and weeks 4 and 24
Change from baseline in number of uninhibited detrusor contractions until leakage or until maximum 135% of age-related bladder capacity
Change in number of of uninhibited detrusor contractions is calculated by urodynamic assessments.
Measured: Baseline and weeks 4 and 24
Change from baseline in maximum catheterized daytime volume
Based on participant e-diary.
Measured: Baseline and up to week 52
Change from baseline in average catheterized daytime volume
Based on participant e-diary.
Measured: Baseline and up to week 52
Change from baseline in average morning catheterized volume
E-diary measure based on first catheterization after participant wakes up.
Measured: Baseline and up to week 52
Change from baseline in number of leakage episodes per 24 hours
Based on participant e-diary.
Measured: Baseline and up to week 52
Change from baseline in number of dry days per 7 days
Based on participant e-diary, dry defined as leakage-free.
Measured: Baseline and up to week 52
Acceptability by pediatric oral medicine acceptability questionnaire for caregivers (P-OMAQ-C)
The P-OMAQ-C uses a 5-point numerical rate scale to measure acceptability of use of the tablet formulation with questions related to taste, smell and administration of study medication. Acceptability questionnaires to be completed by caregivers on an electronic device.
Measured: Baseline and weeks 4, 24 and 52
Frequency of adverse events (AE)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator and events related to the (study) procedures.
Measured: Up to week 54
Number of Participants With Vital Sign Abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Measured: Up to week 54
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to week 52
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Measured: Up to week 54
Number of participants with upper urinary tract ultrasound abnormalities and/or AEs
Number of participants with potentially clinically significant upper urinary tract ultrasounds.
Measured: Up to week 52
PK of mirabegron in plasma: Area under the concentration-time curve per 24 hours (AUC24)
AUC24 will be recorded from the PK plasma samples collected.
Measured: Up to week 52
PK of mirabegron in plasma: Concentration immediately prior to dosing (Ctrough)
Ctrough will be recorded from the PK plasma samples collected.
Measured: Up to week 52
PK of mirabegron in plasma: Apparent clearance (CL/F)
CL/F will be recorded from the PK plasma samples collected.
Measured: Up to week 52
PK of mirabegron in plasma: Apparent volume of distribution (VzF)
VzF will be recorded from the PK plasma samples collected.
Measured: Up to week 52
PK of mirabegron in plasma: Maximum concentration (Cmax)
Cmax will be recorded from the PK plasma samples collected.
Measured: Up to week 52
PK of mirabegron in plasma: Time of maximum concentration (Tmax)
Tmax will be recorded from the PK plasma samples collected.
Measured: Up to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start28 Feb 2024
- Primary completion16 Feb 2026
- Study completion17 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Detrusor OveractivityStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621616
- Sponsor's protocol ID
- 178-CL-207
- Other IDs
- 2021-005455-37, 2023-507903-74, 2023
- Status last verified
- Sep 2026
- First submitted
- 11 Nov 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open Label, Multicenter, Baseline-Controlled Sequential Dose Titration Study Followed by a Fixed Dose Observation Period to Evaluate Pharmacokinetics, Efficacy and Safety of Mirabegron Prolonged-Release Microgranula-Based Suspension in Children From 6 Months to Less Than 3 Years of Age With Neurogenic Detrusor Overactivity
- ClinicalTrials.gov ID
- NCT05621616
- Acronym / sponsor ID
- 178-CL-207
- Conditions
- Neurogenic Detrusor Overactivity
- Keywords
- Neurogenic Detrusor Overactivity, Pediatric acceptability, Bladder capacity, Pharmacokinetics of mirabegron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 18 Nov 2022 (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.
People with neurogenic detrusor overactivity (NDO) have poor bladder control because of how their nerves to the bladder are wired. This can cause high pressure in the bladder, causing it to leak urine by accident (incontinence). Mirabegron has already been approved for adults with bladder problems and for children 3 years and older. This study will learn if mirabegron can help young children with NDO. The children will be from 6 months to up to 3 years old.
The main aim of this study is to learn if mirabegron increases how much urine the bladder holds (maximum cystometric capacity, or Maximum Cystometric Capacity [MCC]) in young children with NDO. An increase in MCC will prevent high pressure in the bladder.
Children from 6 months to up to 3 years old who have NDO can take part. They must weigh 9 kilograms (kg) or more. They will already be fitted with a tube (catheter) in their bladder. They will use this to drain urine from their bladder regularly during the day. This is called clean intermittent catheterization (CIC).
There will be 2 groups in the study. Young children who aren't taking certain medicines for NDO will be in group A. Young children who are taking certain medicines for NDO will be in group B. Children in group B will stop taking these medicines before they start taking mirabegron. Treatment in group B will be delayed to allow the medicines to be cleared from the body before they start taking mirabegron. Both groups (A and B) will have the same treatment and dose of mirabegron and will have the same checks throughout the study.
Mirabegron will be squirted from a syringe into the children's mouths, followed by a sip of water. This will happen once a day for up to 52 weeks (1 year). They will start on a low dose, adjusted for their weight. The dose may be increased to a higher dose if the study doctor thinks the child will benefit from the higher dose.
Children will have safety checks throughout the study. Other tests will include checking how the bladder fills and empties plus an ultrasound of the bladder area.
There will be several clinic visits during the study. There will be fewer clinic visits if a child stays on the low dose of mirabegron. Then, the clinic will phone the caregiver about 1 month after the last dose of mirabegron to check if there are any further medical problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mirabegron | Experimental | Drug: mirabegronParticipants will receive mirabegron prolonged-release microgranula-based oral suspension. |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Participant's weight is a minimum of 9 kg.
- Participant has a previous myelomeningocele (documented at the screening visit).
- Participant has a diagnosis of neurogenic detrusor overactivity (NDO) confirmed by urodynamic investigation at baseline (day 1). The diagnosis of NDO should be confirmed by the presence of ≥ 1 involuntary detrusor contraction > 15 cm H2O from baseline detrusor pressure, and/or a decrease in bladder compliance leading to an increase in baseline detrusor pressure of > 20 cm H2O.
- Participant has a diagnosis of detrusor sphincter dyssynergia (DSD).
- Participant is using clean intermittent catheterization (CIC).
Key exclusion criteria (25 listed)
- Participant has a bladder capacity less than 25% of expected age-related capacity, confirmed by urodynamic investigation at baseline (day 1).
- Participant has vesicoureteral reflux grade 3 to 5.
- Participant has a known genitourinary condition, other than NDO, that may cause overactive contractions and/or incontinence (e.g., bladder exstrophy, urinary tract obstruction, urethral diverticulum or fistula) or kidney/bladder stones or another persistent local pathology that may cause urinary symptoms.
- Participant has had an indwelling urinary catheter within 4 weeks prior to the baseline visit.
- Participant has undergone bladder augmentation surgery.
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 |
|---|---|---|
| mirabegronAlso: Betanis, Betmiga, Myrbetriq, YM178Participants will receive mirabegron prolonged-release microgranula-based oral suspension once daily. The initial dose of mirabegron will be based on the participant's weight. The initial low dose will be up-titrated to a higher dose at weeks 2, 4 or 8 unless the participant is determined to be effectively treated with the low dose, based on urodynamics and the participants'e-diary. | Drug | mirabegron |
Primary outcome
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
Time frame: Baseline and week 24
MCC is maximum bladder capacity reached at end of filling cytometry.
20 secondary outcomes
Change from baseline in bladder compliance
Time frame: Baseline and weeks 4 and 24
Change from baseline in filling volume until first detrusor contraction (>15cm H2O)
Time frame: Baseline and weeks 4 and 24
Change from baseline in number of uninhibited detrusor contractions until leakage or until maximum 135% of age-related bladder capacity
Time frame: Baseline and weeks 4 and 24
Change from baseline in maximum catheterized daytime volume
Time frame: Baseline and up to week 52
Change from baseline in average catheterized daytime volume
Time frame: Baseline and up to week 52
Change from baseline in average morning catheterized volume
Time frame: Baseline and up to week 52
Change from baseline in number of leakage episodes per 24 hours
Time frame: Baseline and up to week 52
Change from baseline in number of dry days per 7 days
Time frame: Baseline and up to week 52
Acceptability by pediatric oral medicine acceptability questionnaire for caregivers (P-OMAQ-C)
Time frame: Baseline and weeks 4, 24 and 52
Frequency of adverse events (AE)
Time frame: Up to week 54
Number of Participants With Vital Sign Abnormalities and/or AEs
Time frame: Up to week 54
Number of participants with laboratory value abnormalities and/or AEs
Time frame: Up to week 52
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Time frame: Up to week 54
Number of participants with upper urinary tract ultrasound abnormalities and/or AEs
Time frame: Up to week 52
PK of mirabegron in plasma: Area under the concentration-time curve per 24 hours (AUC24)
Time frame: Up to week 52
PK of mirabegron in plasma: Concentration immediately prior to dosing (Ctrough)
Time frame: Up to week 52
PK of mirabegron in plasma: Apparent clearance (CL/F)
Time frame: Up to week 52
PK of mirabegron in plasma: Apparent volume of distribution (VzF)
Time frame: Up to week 52
PK of mirabegron in plasma: Maximum concentration (Cmax)
Time frame: Up to week 52
PK of mirabegron in plasma: Time of maximum concentration (Tmax)
Time frame: Up to week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Related trials for Neurogenic Detrusor Overactivity
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TTNS in SCI Patients With Neurogenic Detrusor Overactivity
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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.
Medical Director study director
Astellas Pharma Global Development, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mirabegron in people with Neurogenic Detrusor Overactivity, run by Astellas Pharma Global Development, Inc. at 3 sites in 2 countries.
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 9 inclusion and 25 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: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Philippines, Poland. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC) (time frame: Baseline and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.