Evaluating Vibegron for Children with Neurogenic Detrusor Overactivity
Official title: A Phase 2/3, Open-label, Baseline-controlled, Multicenter, Long-term Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)
Run by Urovant Sciences GmbH · NCT05491525 · Data updated 2026-11-12
This study is testing if vibegron is safe and effective for children aged 2 to under 18 with neurogenic detrusor overactivity who use catheters.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Enrollment | 71 (estimated) |
| Sponsor | Urovant Sciences GmbH Industry-sponsored |
| Locations | 38 sites (Little Rock, Arkansas and 37 other locations) |
| Status | Recruiting |
| Started | October 12, 2022 |
| Main results expected | March 2030 |
| Study ends | September 2030 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT05491525 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 2 to less than 18 years with a diagnosis of NDO who are currently using CIC.
✕Probably not a fit
Patients with conditions such as cerebral palsy or uncontrolled epilepsy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the safety and effectiveness of vibegron in pediatric patients aged 2 to less than 18 years who have been diagnosed with neurogenic detrusor overactivity (NDO) and are using clean intermittent catheterization (CIC). Participants will be divided into two cohorts based on age and weight, and will receive vibegron to evaluate its pharmacokinetics and therapeutic outcomes. The study will monitor participants for a range of safety and efficacy endpoints over the course of the trial.
Why it matters
Potential benefit: If successful, this treatment could significantly improve bladder function and quality of life for children suffering from NDO.
How similar studies have gone: Previous studies have shown promise with beta-3 adrenergic receptor agonists in treating bladder dysfunction, indicating potential for success with this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female participants, age 2 years to \< 18 years and weighing at least 11 kg at the Screening Visit. * Participant has been diagnosed with NDO due to one of the following: spinal dysraphism, which includes spina bifida (eg, myelomeningocele, meningocele) and all forms of tethered cord; or acquired NDO from a spinal cord injury or spinal cord surgery, with the injury/surgery having occurred at least 6 months prior to the Screening Visit; or acquired NDO due to transverse myelitis with diagnosis at least 12 months prior to the Screening Visit. * Participant undergoes CIC at least 3 times per 24 hours (with the last CIC performed prior to going to sleep for the night) for at least 4 weeks prior to the Screening Visit. Exclusion Criteria: * Participant has cerebral palsy, uncontrolled epilepsy, diabetes insipidus, or Stage 2 hypertension * Participant has an active malignancy in the 12 months prior to the Screening Visit. * Participant has been administered intravesical botulinum toxin within 9 months prior to the Screening Visit and should remain off this therapy during the study. * Participant is taking digoxin or lithium within 10 days prior to Screening Visit or plans to start taking either during the study. * Participant currently uses or plans to use a baclofen pump during the study. * Participant has had urethral dilatation or urethral surgery in the 3 months prior to the Screening Visit. * Participant has undergone bladder augmentation surgery. * Participant has a known genitourinary condition (other than NDO) that may cause overactive contractions or incontinence (bladder exstrophy, urinary tract obstruction, urethral diverticulum or fistula) or bladder stones or another persistent urinary tract pathology that may cause symptoms. * Participant has an insufficient urethral sphincter, has had implantation of an artificial sphincter, has a surgically-treated underactive urethral sphincter, or, in the 6 months prior to the Screening Visit, has undergone pelvic gender reassignment surgery. * Participant has one of the following gastrointestinal problems: partial or complete obstruction, decreased motility such as paralytic ileus, risk of gastric retention, or malabsorption syndrome of any form. * Participant has acute fecal impaction or, within the 3 months prior to the Screening Visit, had fecal impaction that required hospitalization or ambulatory surgical treatment. * Participant had a urinary indwelling catheter in the 4 weeks prior to the Screening Visit. * Participant has moderate to severe dilating vesicoureteral reflux (Grade IV to V) or severe renal failure. * Participant started electrostimulation/neuromodulation therapy in the 4 weeks before the Screening Visit, or is expected to start this therapy during the study period. * Participant has participated in another clinical trial and/or has taken an investigational drug within 4 weeks prior to the Screening Visit. * Participant is unable, or parent/caregiver is not willing, to washout any medication for the management of NDO. * Participant is a female of childbearing potential who is unwilling or unable to use a highly effective method of contraception for the duration of the study. * Female participants who are currently breastfeeding or plan to breastfeed any time from the Screening Visit until 28 days after the final study drug administration.
Where it's running
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Arkansas Childrens Hospital
Little Rock, Arkansas, United States Recruiting -
Children's Hospital Colorado
Aurora, Colorado, United States Recruiting -
Nemours Childrens Health, Jacksonville
Jacksonville, Florida, United States Recruiting -
Wichita Urology Group
Wichita, Kansas, United States Recruiting -
Albany Medical College
Albany, New York, United States Recruiting -
SUNY Upstate Medical University
Syracuse, New York, United States Recruiting
Show 32 more locations
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University of Oklahoma
Oklahoma City, Oklahoma, United States Recruiting -
UZ Gent
Ghent, East Flanders, Belgium Recruiting -
Alberta Children's Hospital
Calgary, Alberta, Canada Recruiting -
The Hospital for Sick Children
Toronto, Ontario, Canada Recruiting -
University Hospital Split - KBC Split
Split, Croatia Recruiting -
Aarhus University Hospital - Department of Paediatrics and Adolescent Medicine
Aarhus, Denmark Recruiting -
JSC Evex Hospital M. lashvili Childrens Central Hospital
Tbilisi, Georgia Recruiting -
Istiklal Hospital
Amman, Jordan Recruiting -
Jordan University Hospital
Amman, Jordan Recruiting -
Irbid Specialty Hospital
Irbid, Jordan Recruiting -
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Lithuania Recruiting -
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania Recruiting -
Kuala Lumpur Hospital
Kuala Lumpur, Kuala Lumpur, Malaysia Recruiting -
Hospital Umum Sarawak
Kuching, Sarawak, Malaysia Recruiting -
National Children's Hospital
Quezon City, National Capital Region, Philippines Recruiting -
Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
Bialystok, Poland Recruiting -
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland Recruiting -
Instytut Pomnik - Centrum Zdrowia Dziecka
Warsaw, Poland Recruiting -
Institutul Clinic Fundeni
Bucharest, Bucharest, Romania Recruiting -
Maria Sklodowska Curie Childrens Clinical Emergency Hospital
Bucharest, Bucharest, Romania Recruiting -
University Children's Hospital Tirsova
Belgrade, Serbia Recruiting -
Children and Youth Health Care Institute of Vojvodina
Novi Sad, Serbia Recruiting -
Detská fakultná nemocnica s poliklinikou/Národný ústav detských chorôb (NÚDCH)
Bratislava, Slovakia Recruiting -
Urologická ambulancia J. BREZA MEDICAL s.r.o.
Bratislava, Slovakia Recruiting -
Ankara University Faculty of Medicine Ibni Sina Hospital
Ankara, Altindag, Turkey (Türkiye) Recruiting -
Mersin University, Dept. of Urology
Yenişehir, Turkey (Türkiye) Recruiting -
Children's Hospital of Orange County
Orange, California, United States Terminated -
Childrens Hospital New Orleans
New Orleans, Louisiana, United States Withdrawn -
Duke University Medical Center
Durham, North Carolina, United States Terminated -
Oregon Health & Science University
Portland, Oregon, United States Withdrawn -
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, Belgium Withdrawn -
Childrens Clinical University Hospital
Riga, Latvia Withdrawn
Study contacts
- Study coordinator: Study Director
- Email: clinicaltrials@us.sumitomo-pharma.com
- Phone: 833-876-8268
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Testing EG110A injections for bladder control in spinal cord injury patients
This study is testing if EG110A injections can help people with spinal cord injuries who have trouble controlling their bladder feel more comfortable and manage their incontinence better.
-
Improving pelvic rehabilitation after spinal cord injury with epidural stimulation
This study is testing if using a special device to stimulate the spinal cord can help people with spinal cord injuries improve their bladder and bowel function through pelvic rehabilitation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.