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
Public ClinicalTrials.gov record NCT05491525. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT05491525
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 71 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 11, 2022
- Primary completion
- Feb 28, 2030
- Completion
- Aug 31, 2030
- Last update posted
- Jun 14, 2026
2022 – 2030
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Childrens Hospital | Little Rock | Arkansas | 72202 | Recruiting |
| Children's Hospital of Orange County | Orange | California | 92868-4568 | Terminated |
| Children's Hospital Colorado | Aurora | Colorado | 800045 | Recruiting |
| Nemours Childrens Health, Jacksonville | Jacksonville | Florida | 32207 | Recruiting |
| Wichita Urology Group | Wichita | Kansas | 67226 | Recruiting |
| Childrens Hospital New Orleans | New Orleans | Louisiana | 70118 | Withdrawn |
| Albany Medical College | Albany | New York | 12208 | Recruiting |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | Recruiting |
| Duke University Medical Center | Durham | North Carolina | 27710 | Terminated |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Oregon Health & Science University | Portland | Oregon | 97239 | Withdrawn |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05491525, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 14, 2026 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05491525 live on ClinicalTrials.gov.