RecruitingPhase 2Phase 3NCT05491525

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

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)

Sponsor

Urovant Sciences GmbH

Enrollment

71 participants

Start Date

Oct 12, 2022

Study Type

INTERVENTIONAL

Conditions

neurogenic detrusor overactivity

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

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Vibegron for people with neurogenic detrusor overactivity. The study is currently recruiting participants at 38 locations. People eligible for this study include aged 2 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVibegron

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

Locations(38)

Arkansas Childrens Hospital

Little Rock, Arkansas, United States

Children's Hospital of Orange County

Orange, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Nemours Childrens Health, Jacksonville

Jacksonville, Florida, United States

Wichita Urology Group

Wichita, Kansas, United States

Childrens Hospital New Orleans

New Orleans, Louisiana, United States

Albany Medical College

Albany, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

Universitair Ziekenhuis Antwerpen

Edegem, Antwerpen, Belgium

UZ Gent

Ghent, East Flanders, Belgium

Alberta Children's Hospital

Calgary, Alberta, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

University Hospital Split - KBC Split

Split, Croatia

Aarhus University Hospital - Department of Paediatrics and Adolescent Medicine

Aarhus, Denmark

JSC Evex Hospital M. lashvili Childrens Central Hospital

Tbilisi, Georgia

Istiklal Hospital

Amman, Jordan

Jordan University Hospital

Amman, Jordan

Irbid Specialty Hospital

Irbid, Jordan

Childrens Clinical University Hospital

Riga, Latvia

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Kuala Lumpur Hospital

Kuala Lumpur, Kuala Lumpur, Malaysia

Hospital Umum Sarawak

Kuching, Sarawak, Malaysia

National Children's Hospital

Quezon City, National Capital Region, Philippines

Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa

Bialystok, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Instytut Pomnik - Centrum Zdrowia Dziecka

Warsaw, Poland

Institutul Clinic Fundeni

Bucharest, Bucharest, Romania

Maria Sklodowska Curie Childrens Clinical Emergency Hospital

Bucharest, Bucharest, Romania

University Children's Hospital Tirsova

Belgrade, Serbia

Children and Youth Health Care Institute of Vojvodina

Novi Sad, Serbia

Detská fakultná nemocnica s poliklinikou/Národný ústav detských chorôb (NÚDCH)

Bratislava, Slovakia

Urologická ambulancia J. BREZA MEDICAL s.r.o.

Bratislava, Slovakia

Ankara University Faculty of Medicine Ibni Sina Hospital

Ankara, Altindag, Turkey (Türkiye)

Mersin University, Dept. of Urology

Yenişehir, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05491525

Related Trials

Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adults With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization

NCT065962914 locations

Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury

NCT065152231 location