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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

NCT05491525 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2026-06-15

No results posted yet for this study

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

Conditions

  • Neurogenic Detrusor Overactivity

Interventions

DRUG

Vibegron

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

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    collaborator INDUSTRY

  • Urovant Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • Janet Owens-Grillo · Sumitomo Pharma America

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-12
Primary Completion
2030-03-31
Completion
2030-09-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Croatia
  • Denmark
  • Georgia
  • Jordan
  • Latvia
  • Lithuania
  • Malaysia
  • Philippines
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05491525 on ClinicalTrials.gov