Urinary Incontinence in ChildrenPhase 3NCT06551246
Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)
A Phase 3 study testing Solifenacin and Mirabegron in people with Urinary Incontinence in Children, run by University of Aarhus at 5 sites in Denmark.
Trial summary
The primary objective is to evaluate if (1) combination therapy of solifenacin and mirabegron in low doses is superior to monotherapy of solifenacin in high dose and if (2) combination therapy of mirabegron and solifenacin in low doses is superior to monotherapy of mirabegron in high dose in treatment of daytime… Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Urinary Incontinence in Children
- What is being tested?
- Solifenacin and Mirabegron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 5 sitesDenmark
- Study dates
- 27 Jun 2024to 1 Dec 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study specific procedures.
- Age 5 to 14 years (inclusive) at the time of inclusion.
- Overactive bladder as per International Children's Continence Society criteria
- At least 2 daytime urinary incontinence episodes per week
- Inadequate effect of at least 4 weeks urotherapy (non-pharmacological treatment)
- No previous treatment with solifenacin, mirabegron or bladder/sphincter botulinum toxin injections
- No current constipation as per ROME IV criteria or fecal incontinence (laxative treatment is accepted)
- Per investigator's judgment, the participant can swallow or can learn to swallow study medication
Who cannot join
- Inability of the patent(s) or legal guardian(s) to understand the Danish written and oral information
- Known or suspected hypersensitivity to study medication
- Any contraindication to the use of the study medication
- Known urogenital anatomical abnormalities affecting lower urinary tract function
- Known kidney or bladder stones
- Known diabetes insipidus
Show all 20Show fewer
- Ongoing symptomatic urinary tract infection
- Recurrent urinary tract infection or ongoing prophylactic antibiotic treatment
- Known QTc prolongation, QTc >460 ms, or risk of QTc prolongation (hypokalaemia, exercise-induced syncope, or familial long QT syndrome)
- Other significant electrocardiogram abnormalities
- Known hypertension
- ≤3 daily voiding, evaluated by 48-hour frequency-volume chart
- Uroflowmetry suggestive of other pathology than overactive bladder (staccato-shaped, interrupted-shaped, or plateau-shaped curve)
- Post-void residual >50 ml after double voiding
- Dipstick haematuria (≥2+ erythrocytes) or macroscopic haematuria
- Pregnancy or breastfeeding
- Female subjects of childbearing potential
- Ongoing constipation according to Rome IV-criteria which is intractable to medication or fecal incontinence
- Inability to swallow study medication
- Use of any medication during study period, except permitted medication
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Department of Pediatric and Adolescent Medicine, Aalborg University Hospital
Aalborg, Aalborg, 9000
Søren Hagstrøm, Professor, +45 97663374, soha@rm.dk
- Recruiting
Department of Pediatric and Adolescent Medicine, Aarhus University Hospital
Aarhus, Aarhus N, 8200
Konstantinos Kamperis, MD, PhD, konskamp@rm.dk
Ann-Kristine Mandøe Svendsen, MD
- Recruiting
Department of Pediatric and Adolescent medicine, Esbjerg Hospital
Esbjerg, Esbjerg, 6700
Linda Kuhne-Qvist, MD, Linda.Kuhne-qvist2@rsyd.dk
- Recruiting
Department of Pediatric and Adolescent Medicine, Gødstrup Hospital
Herning, Herning, 7400
Luise Borch, MD, PhD, +45 78433654, luise.borch@rm.dk
Ann-Kristine Mandøe Svendsen, MD
- Recruiting
Department of Pediatric and Adolescent Medicine, Kolding Hospital
Kolding, Kolding, 6000
Louise Winding, MD, louise.winding1@rsyd.dk
About this study
Official title: Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Overactive Bladder and Daytime Urinary Incontinence (BeDry)
The primary objective is to evaluate if (1) combination therapy of solifenacin and mirabegron in low doses is superior to monotherapy of solifenacin in high dose and if (2) combination therapy of mirabegron and solifenacin in low doses is superior to monotherapy of mirabegron in high dose in treatment of daytime urinary incontinence among children aged 5 to 14 years who are none complete responders to respectively monotherapy of solifenacin in low dose or monotherapy of mirabegron in low dose.
In total, 236 children diagnosed with daytime urinary incontinence will be randomized 1:1:1:1 to one of four treatment groups. Total pharmacological treatment period will be 18 weeks.
Read the detailed description
Background: According to International Children's Continence Society, first-line treatment of children with daytime urinary incontinence is standard urotherapy, eventually followed by pharmacotherapy of anticholinergics. The effect of medical treatment is sparsely investigated and primarily in non-randomized trials.
Objectives: The primary objective is to evaluate if (1) combination therapy of solifenacin and mirabegron in low doses is superior to monotherapy of solifenacin in high dose and if (2) combination therapy of mirabegron and solifenacin in low doses is superior to monotherapy of mirabegron in high dose in treatment of daytime urinary incontinence among children aged 5 to 14 years who are none complete responders to respectively monotherapy of solifenacin in low dose or monotherapy of mirabegron in low dose.
The secondary objective is to evaluate the treatment response of combination therapy of solifenacin and mirabegron in low doses, monotherapy in high dose and monotherapy in low doses as supplementary comparisons. Additionally, the secondary objective is to evaluate side effects, safety, and tolerability of the medical treatment as well as the effect of treatment on well-being and quality of life.
Study design: The BeDry study is designed as a multicenter, randomized, single-blinded, controlled clinical trial. Included children will be randomized 1:1:1:1 to one of four treatment groups. Children aged 5-14 years diagnosed with daytime urinary incontinence refractory to standard urotherapy will be randomized. Initially two groups will receive solifenacin 5 mg and two groups will receive mirabegron 25 mg. After 6 weeks, non-complete respondsers will receive add-on treatment according to their primary randomization group; group 1A will reviece solifenacin 5 mg and add-on solifenacin 5 mg, group 1B will receive solifenacin 5 mg and add-on mirabegron 25 mg, group 2A will receive mirabegron 25 mg and add-on mirabegron 25 mg, group 2B will receive mirabegron 25 mg and add-on solifenacin 5 mg. Total treatment period will be 18 weeks. The primary endpoint measure is treatment response assessed by change from visit 2 to end of study, according to number of wet days pr. 7 days by DryPie.
Perspectives: The trial has the potential to optimize medical treatment of children with daytime urinary incontinence, to shorten the treatment period, diminish side effects and minimized unnecessary medical expenses.
Ethics: All pharmacological side effects will be handled in accordance with the Danish legislation. No risk or unknown side effects are expected to urotherapy, medical treatment or withdrawal. No risks are expected by the clinical examination and paraclinical measurements. The therapeutic potential for future patients justifies the project to be carried out. Participation in this study will not lead to any disadvantages for the patient in their treatment. The study will be conducted in accordance with the protocol, applicable regulatory requirements according to Good Clinical Practice and the ethical principles of the Declaration of Helsinki. The study is approved by the authorities. Significant additions or changes to the protocol may be conducted after the application for amendment is approved by the Regulatory Authority and the Ethics Committee. Information regarding the participants is protected according to the General Data Protection Regulation and the actual law. The study is registered at the research inventory of the Regions of Denmark (1-16-02-210-24) and at Aarhus University (ARG-2024-731-23829). The study is registered and authorized at CTIS (EU CT 2023-510187-13-00).
- Conditions
- Urinary Incontinence in Children
- Being tested
- Solifenacin, Mirabegron
- Keywords
- Urinary incontinence, Daytime urinary incontinence, Overactive bladder, Children, Solifenacin, Mirabegron
- Medical subject headings
- Urinary Incontinence, Diurnal Enuresis, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolifenacinDrug
According to randomization.
MirabegronDrug
According to randomization.
| Study group | Role | What they receive |
|---|---|---|
| Solifenacin 5 mg + add-on solifenacin 5 mg | Experimental | Group 1A: Solifenacin 5 mg for 6 weeks, and if non-complete response after 6 weeks add-on solifenacin 5 mg for 12 weeks. Receives: Drug: Solifenacin |
| Solifenacin 5 mg + add-on mirabegron 25 mg | Experimental | Group 1B: Solifenacin 5 mg for 6 weeks, and if non-complete response after 6 weeks add-on mirabegron 25 mg for 12 weeks. Receives: Drug: Solifenacin; Drug: Mirabegron |
| Mirabegron 25 mg + ad-on mirabegron 25 mg | Experimental | Group 2A: Mirabegron 25 mg for 6 weeks, and if non-complete response after 6 weeks add-on mirabegron 25 mg for 12 weeks. Receives: Drug: Mirabegron |
| Mirabegron 25 mg + add-on solifenacin 5 mg | Experimental | Group 2B: Mirabegron 25 mg for 6 weeks, and if non-complete response after 6 weeks add-on solifenacin 5 mg for 12 weeks. Receives: Drug: Solifenacin; Drug: Mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response
Assesed by change in number of wetdays pr. 7 days by DryPie
Measured: From study week 6 and through study completion, an average of 18 weeks in total
Secondary outcomes (9)
Treatment response
Assesed by change in number of wetdays pr. 7 days by DryPie
Measured: From date of randomization until study completion, an average of 18 weeks in total
Inconcintnence severity score
Assesed by DryPie (scoring from 0 to 21, in which the higher score means severe incontinence)
Measured: From date of randomization until study completion, an average of 18 weeks in total
Urge severity
Quantified by Bower VAS Urgency Scheme (scoring from 0 to 10, in which the higher score means servere urge)
Measured: From date of randomization until study completion, an average of 18 weeks in total
Maximum voided volume (ml)
48-hour frequency-volume chart
Measured: From date of randomization until study completion, an average of 18 weeks in total
Age standardized maximum voided volume (ml)
Maximum voided volume as a percent of expected bladder capacity
Measured: From date of randomization until study completion, an average of 18 weeks in total
Average voided volume (ml)
48-hour frequency-volume chart
Measured: From date of randomization until study completion, an average of 18 weeks in total
Miction frequency
48-hour frequency-volume chart
Measured: From date of randomization until study completion, an average of 18 weeks in total
Pediatric incontinence questionnaire total score
20-item questionnaire (scoring from 0 to 4 on a Likert scale, with a total of 80 points in which the higher score, the greater impact of urinary incontinence of quality of life)
Measured: From date of randomization until study completion, an average of 18 weeks in total
WHO-5 total score
5-item questionnaire (scoring from 0 to 5 on a Likert scale, with a total of 30 points in which the higher score, the greater impact of urinary incontinence of quality of life)
Measured: From date of randomization until study completion, an average of 18 weeks in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start27 Jun 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence in ChildrenStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children aged 5-14 years diagnosed with daytime urinary incontinence refractory to standard urotherapy will be randomized to four treatment groups, randomization 1:1:1:1.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luise Borch, MD, PhD, Study director, Department of Pediatric and Adolescent Medicine, Gødstrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551246
- Sponsor's protocol ID
- BeDry
- Status last verified
- Dec 2025
- First submitted
- 25 Jun 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Svendsen AM, Hagstrom S, Thorsteinsson K, Van Batavia J, Kamperis K, Olesen AE, Borch L. Efficacy of Solifenacin, Mirabegron, and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry): Protocol for a Randomized Single-Blinded Controlled Trial. JMIR Res Protoc. 2025 Jun 26;14:e63588. doi: 10.2196/63588.
PubMed 40570329
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Overactive Bladder and Daytime Urinary Incontinence (BeDry)
- ClinicalTrials.gov ID
- NCT06551246
- Acronym / sponsor ID
- BeDry
- Conditions
- Urinary Incontinence in Children
- Keywords
- Urinary incontinence, Daytime urinary incontinence, Overactive bladder, Children, Solifenacin, Mirabegron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to evaluate if (1) combination therapy of solifenacin and mirabegron in low doses is superior to monotherapy of solifenacin in high dose and if (2) combination therapy of mirabegron and solifenacin in low doses is superior to monotherapy of mirabegron in high dose in treatment of daytime urinary incontinence among children aged 5 to 14 years who are none complete responders to respectively monotherapy of solifenacin in low dose or monotherapy of mirabegron in low dose.
In total, 236 children diagnosed with daytime urinary incontinence will be randomized 1:1:1:1 to one of four treatment groups. Total pharmacological treatment period will be 18 weeks.
Detailed description
Background: According to International Children's Continence Society, first-line treatment of children with daytime urinary incontinence is standard urotherapy, eventually followed by pharmacotherapy of anticholinergics. The effect of medical treatment is sparsely investigated and primarily in non-randomized trials.
Objectives: The primary objective is to evaluate if (1) combination therapy of solifenacin and mirabegron in low doses is superior to monotherapy of solifenacin in high dose and if (2) combination therapy of mirabegron and solifenacin in low doses is superior to monotherapy of mirabegron in high dose in treatment of daytime urinary incontinence among children aged 5 to 14 years who are none complete responders to respectively monotherapy of solifenacin in low dose or monotherapy of mirabegron in low dose.
The secondary objective is to evaluate the treatment response of combination therapy of solifenacin and mirabegron in low doses, monotherapy in high dose and monotherapy in low doses as supplementary comparisons. Additionally, the secondary objective is to evaluate side effects, safety, and tolerability of the medical treatment as well as the effect of treatment on well-being and quality of life.
Study design: The BeDry study is designed as a multicenter, randomized, single-blinded, controlled clinical trial. Included children will be randomized 1:1:1:1 to one of four treatment groups. Children aged 5-14 years diagnosed with daytime urinary incontinence refractory to standard urotherapy will be randomized. Initially two groups will receive solifenacin 5 mg and two groups will receive mirabegron 25 mg. After 6 weeks, non-complete respondsers will receive add-on treatment according to their primary randomization group; group 1A will reviece solifenacin 5 mg and add-on solifenacin 5 mg, group 1B will receive solifenacin 5 mg and add-on mirabegron 25 mg, group 2A will receive mirabegron 25 mg and add-on mirabegron 25 mg, group 2B will receive mirabegron 25 mg and add-on solifenacin 5 mg. Total treatment period will be 18 weeks. The primary endpoint measure is treatment response assessed by change from visit 2 to end of study, according to number of wet days pr. 7 days by DryPie.
Perspectives: The trial has the potential to optimize medical treatment of children with daytime urinary incontinence, to shorten the treatment period, diminish side effects and minimized unnecessary medical expenses.
Ethics: All pharmacological side effects will be handled in accordance with the Danish legislation. No risk or unknown side effects are expected to urotherapy, medical treatment or withdrawal. No risks are expected by the clinical examination and paraclinical measurements. The therapeutic potential for future patients justifies the project to be carried out. Participation in this study will not lead to any disadvantages for the patient in their treatment. The study will be conducted in accordance with the protocol, applicable regulatory requirements according to Good Clinical Practice and the ethical principles of the Declaration of Helsinki. The study is approved by the authorities. Significant additions or changes to the protocol may be conducted after the application for amendment is approved by the Regulatory Authority and the Ethics Committee. Information regarding the participants is protected according to the General Data Protection Regulation and the actual law. The study is registered at the research inventory of the Regions of Denmark (1-16-02-210-24) and at Aarhus University (ARG-2024-731-23829). The study is registered and authorized at CTIS (EU CT 2023-510187-13-00).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Children aged 5-14 years diagnosed with daytime urinary incontinence refractory to standard urotherapy will be randomized to four treatment groups, randomization 1:1:1:1.
| Arm | Type | Receives |
|---|---|---|
| Solifenacin 5 mg + add-on solifenacin 5 mg | Experimental | Drug: SolifenacinGroup 1A: Solifenacin 5 mg for 6 weeks, and if non-complete response after 6 weeks add-on solifenacin 5 mg for 12 weeks. |
| Solifenacin 5 mg + add-on mirabegron 25 mg | Experimental | Drug: Solifenacin, Drug: MirabegronGroup 1B: Solifenacin 5 mg for 6 weeks, and if non-complete response after 6 weeks add-on mirabegron 25 mg for 12 weeks. |
| Mirabegron 25 mg + ad-on mirabegron 25 mg | Experimental | Drug: MirabegronGroup 2A: Mirabegron 25 mg for 6 weeks, and if non-complete response after 6 weeks add-on mirabegron 25 mg for 12 weeks. |
| Mirabegron 25 mg + add-on solifenacin 5 mg | Experimental | Drug: Solifenacin, Drug: MirabegronGroup 2B: Mirabegron 25 mg for 6 weeks, and if non-complete response after 6 weeks add-on solifenacin 5 mg for 12 weeks. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study specific procedures.
- Age 5 to 14 years (inclusive) at the time of inclusion.
- Overactive bladder as per International Children's Continence Society criteria
- At least 2 daytime urinary incontinence episodes per week
- Inadequate effect of at least 4 weeks urotherapy (non-pharmacological treatment)
Key exclusion criteria (20 listed)
- Inability of the patent(s) or legal guardian(s) to understand the Danish written and oral information
- Known or suspected hypersensitivity to study medication
- Any contraindication to the use of the study medication
- Known urogenital anatomical abnormalities affecting lower urinary tract function
- Known kidney or bladder stones
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 |
|---|---|---|
| SolifenacinAccording to randomization. | Drug | Mirabegron 25 mg + add-on solifenacin 5 mg, Solifenacin 5 mg + add-on mirabegron 25 mg, Solifenacin 5 mg + add-on solifenacin 5 mg |
| MirabegronAccording to randomization. | Drug | Mirabegron 25 mg + ad-on mirabegron 25 mg, Mirabegron 25 mg + add-on solifenacin 5 mg, Solifenacin 5 mg + add-on mirabegron 25 mg |
Primary outcome
Treatment response
Time frame: From study week 6 and through study completion, an average of 18 weeks in total
Assesed by change in number of wetdays pr. 7 days by DryPie
9 secondary outcomes
Treatment response
Time frame: From date of randomization until study completion, an average of 18 weeks in total
Inconcintnence severity score
Time frame: From date of randomization until study completion, an average of 18 weeks in total
Urge severity
Time frame: From date of randomization until study completion, an average of 18 weeks in total
Maximum voided volume (ml)
Time frame: From date of randomization until study completion, an average of 18 weeks in total
Age standardized maximum voided volume (ml)
Time frame: From date of randomization until study completion, an average of 18 weeks in total
Average voided volume (ml)
Time frame: From date of randomization until study completion, an average of 18 weeks in total
Miction frequency
Time frame: From date of randomization until study completion, an average of 18 weeks in total
Pediatric incontinence questionnaire total score
Time frame: From date of randomization until study completion, an average of 18 weeks in total
WHO-5 total score
Time frame: From date of randomization until study completion, an average of 18 weeks in total
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 8 Jun 2026.
- Derived from this study: PubMed 40570329Svendsen AM, Hagstrom S, Thorsteinsson K, Van Batavia J, Kamperis K, Olesen AE, Borch L. Efficacy of Solifenacin, Mirabegron, and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry): Protocol for a Randomized Single-Blinded Controlled Trial. JMIR Res Protoc. 2025 Jun 26;14:e63588. doi: 10.2196/63588.
- 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.
Luise Borch, MD, PhD study director
Department of Pediatric and Adolescent Medicine, Gødstrup Hospital
5 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 Solifenacin and Mirabegron in people with Urinary Incontinence in Children, run by University of Aarhus at 5 sites in Denmark.
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 8 inclusion and 20 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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?
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 Ann-Kristine Mandøe Svendsen, MD (+45 78430408, ankrso@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response (time frame: From study week 6 and through study completion, an average of 18 weeks in total). 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 NCT06551246, which also lists 1 linked publication.
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 8 Jun 2026.