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Clinical Trials in the USA / NCT05491525
Recruiting Phase 2/3

Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC

NCT05491525 · tracked via the Priya Life Science USA tracker
Sponsor
Urovant Sciences GmbH
Phase
Phase 2/3
Started
2022-10-12
Last updated
2026-06-15

Condition(s) studied

Neurogenic Detrusor Overactivity

Investigational drug(s) / intervention(s)

Vibegron

Vibegron: Participants will be administered Vibegron orally, once daily (QD)

Study summary

The purpose of this study is to evaluate the safety, efficacy, and PK of Vibegron in pediatric participants with NDO who are regularly using CIC

Eligibility

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
Arkansas Childrens Hospital Little Rock Arkansas Recruiting
Children's Hospital of Orange County Orange California Terminated
Children's Hospital Colorado Aurora Colorado Recruiting
Nemours Childrens Health, Jacksonville Jacksonville Florida Recruiting
Wichita Urology Group Wichita Kansas Recruiting
Childrens Hospital New Orleans New Orleans Louisiana Withdrawn
Albany Medical College Albany New York Recruiting
SUNY Upstate Medical University Syracuse New York Recruiting
Duke University Medical Center Durham North Carolina Terminated
University of Oklahoma Oklahoma City Oklahoma Recruiting
Oregon Health & Science University Portland Oregon Withdrawn
Universitair Ziekenhuis Antwerpen Edegem Antwerpen Withdrawn
UZ Gent Ghent East Flanders Recruiting
Alberta Children's Hospital Calgary Alberta Recruiting
The Hospital for Sick Children Toronto Ontario 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
Childrens Clinical University Hospital Riga Latvia Withdrawn
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 Recruiting
Hospital Umum Sarawak Kuching Sarawak Recruiting
National Children's Hospital Quezon City National Capital Region 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 Recruiting
Maria Sklodowska Curie Childrens Clinical Emergency Hospital Bucharest Bucharest 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 Recruiting
Mersin University, Dept. of Urology Yenişehir Turkey (Türkiye) Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05491525 on ClinicalTrials.gov ↗ ← All trials in the USA