Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05491525
PHASE2/PHASE3

A Study of Vibegron in Pediatric Participants 2 Years to Less Than (<) 18 Years of Age With NDO and on CIC

Sponsor: Urovant Sciences GmbH

View on ClinicalTrials.gov

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

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)

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

85

Start Date

2022-10-12

Completion Date

2027-09

Last Updated

2024-07-03

Healthy Volunteers

No

Interventions

DRUG

Vibegron

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

Locations (6)

Children's Hospital of Orange County

Orange, California, 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

Duke University Medical Center

Durham, North Carolina, United States