Clinical trial Recruiting at 32 sites Phase2; Phase3 Interventional Ages 2 to 17

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

PhasePhase2; Phase3
Study typeInterventional
Ages2 Years to 17 Years
SexAll
Enrollment71 (estimated)
SponsorUrovant Sciences GmbH
Industry-sponsored
Locations38 sites (Little Rock, Arkansas and 37 other locations)
StatusRecruiting
StartedOctober 12, 2022
Main results expectedMarch 2030
Study endsSeptember 2030
Registry record updatedJune 15, 2026
Trial IDNCT05491525 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.