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
Part of paid clinical trials in Little Rock, Arkansas.
- Sponsor
- Urovant Sciences GmbH
- Study ID
- NCT05491525
- Phase
- PHASE2/PHASE3
- Status
- Recruiting
Conditions
- Neurogenic Detrusor Overactivity
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Vibegron — DRUGParticipants will be administered Vibegron orally, once daily (QD)
Study Details
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
Key Dates
- First listed
- Aug 8, 2022
- Start date
- Oct 12, 2022
- Status verified
- Jun 2026
- Primary completion
- Mar 31, 2030
- Completion
- Sep 30, 2030
Study Design
- Enrollment
- 71 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1: Weight >=41.5kgPart A: Participants will receive a dose of Vibegron based on their weight, with dose reduction based on individual clinical condition, PK, and safety/tolerability data. Participants may be dose-reduced up to 2 times. Part B: Participants will receive a Data and Safety Monitoring Board (DSMB)-selected Vibegron dose for their weight determined from participants in their respective cohort and weight band of Part A.
- Experimental: Cohort 2: Weight Range >=29.5 kg to <=41.4 kgPart A: participants will receive a dose of Vibegron based on their weight, with dose reduction based on individual clinical condition, PK, and safety/tolerability data. Participants may be dose-reduced up to 2 times. Part B: Participants will receive a DSMB-selected Vibegron dose for their weight determined from participants in their respective cohort and weight band of Part A.
- Experimental: Cohort 3: Weight range >=11 kg to <=29.4 kgPart A: Participants will receive a dose of Vibegron based on their weight, with dose reduction based on individual clinical condition, PK, and safety/tolerability data. Participants may be dose-reduced up to 2 times. Part B: Participants will receive a DSMB-selected Vibegron dose for their weight determined from participants in their respective cohort and weight band of Part A.
Primary Outcome Measure
Change from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamics [ Time Frame: Optimized Treatment Week 24 ]
Central Contacts
- Study Director833-876-8268
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arkansas Childrens Hospital | Little Rock | Arkansas | 72202 | Ashay Patel (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Orange County | Orange | California | 92868-4568 | - |
| Children's Hospital Colorado | Aurora | Colorado | 800045 | Kyle Rove (PRINCIPAL_INVESTIGATOR) |
| Nemours Childrens Health, Jacksonville | Jacksonville | Florida | 32207 | Andrew Stec (PRINCIPAL_INVESTIGATOR) |
| Wichita Urology Group | Wichita | Kansas | 67226 | Kahlil N Saad (PRINCIPAL_INVESTIGATOR) |
| Childrens Hospital New Orleans | New Orleans | Louisiana | 70118 | - |
| Albany Medical College | Albany | New York | 12208 | Alexandra Rehfuss (PRINCIPAL_INVESTIGATOR) |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | Jeffery Villanueva (PRINCIPAL_INVESTIGATOR) |
| Duke University Medical Center | Durham | North Carolina | 27710 | - |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | Dominic Frimberger (PRINCIPAL_INVESTIGATOR) |
| Oregon Health & Science University | Portland | Oregon | 97239 | - |