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🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2026-06-15)

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

🟢 Recruiting Phase 2 💊 Investigational Drug / Biologic Sponsor: Urovant Sciences GmbH

🩺 Protocol 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

Primary Research Facility: Arkansas Childrens Hospital (Little Rock, Arkansas)

📋 Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

📍 Primary Site Map

Site: Arkansas Childrens Hospital — Little Rock, Arkansas

📍 All Participating Trial Locations (38 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Arkansas Childrens Hospital — Little Rock, Arkansas
2. Children's Hospital of Orange County — Orange, California
3. Children's Hospital Colorado — Aurora, Colorado
4. Nemours Childrens Health, Jacksonville — Jacksonville, Florida
5. Wichita Urology Group — Wichita, Kansas
6. Childrens Hospital New Orleans — New Orleans, Louisiana
7. Albany Medical College — Albany, New York
8. SUNY Upstate Medical University — Syracuse, New York
9. Duke University Medical Center — Durham, North Carolina
10. University of Oklahoma — Oklahoma City, Oklahoma
11. Oregon Health & Science University — Portland, Oregon
12. Universitair Ziekenhuis Antwerpen — Edegem, Antwerpen
13. UZ Gent — Ghent, East Flanders
14. Alberta Children's Hospital — Calgary, Alberta
15. The Hospital for Sick Children — Toronto, Ontario
16. University Hospital Split - KBC Split — United States
17. Aarhus University Hospital - Department of Paediatrics and Adolescent Medicine — United States
18. JSC Evex Hospital M. lashvili Childrens Central Hospital — United States
19. Istiklal Hospital — United States
20. Jordan University Hospital — United States
21. Irbid Specialty Hospital — United States
22. Childrens Clinical University Hospital — United States
23. Hospital of Lithuanian University of Health Sciences Kauno klinikos — United States
24. Vilnius University Hospital Santaros Klinikos — United States
25. Kuala Lumpur Hospital — Kuala Lumpur, Kuala Lumpur

📄 Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT05491525 • Last Synced: 2026-06-15
View on ClinicalTrials.gov ↗
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