Trial · NCT05491525
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, Phase 2, Phase 3, Recruiting, Urovant Sciences GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT05491525. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05491525
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT05491525
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 71 participants, estimated
- Lead sponsor
- Urovant Sciences GmbH
- Conditions
- Neurogenic Detrusor Overactivity
- Interventions
- Vibegron
- First posted
- 2022-08-08
- Last updated
- 2026-06-15
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamics | Optimized Treatment Week 24 | |
| Secondary | Change from Baseline in MCC | Optimized Week 12 | |
| Secondary | Change from Baseline in number of overactive detrusor contractions until the end of bladder filling | Optimized Treatment Weeks 12 and 24 | |
| Secondary | Change from Baseline in detrusor pressure at the end of bladder filling | Optimized Treatment Weeks 12 and 24 | |
| Secondary | Change from Baseline in bladder filling volume until first involuntary/hyperactive detrusor contraction | Optimized Treatment Weeks 12 and 24 | |
| Secondary | Change from Baseline in bladder compliance (mL/cm H2O) | Optimized Treatment Weeks 12 and 24 | Bladder compliance is calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder |
| Secondary | Change from Baseline in average first morning catheterized volume | through study completion, an average of 52 weeks | |
| Secondary | Change from Baseline in average catheterized volume per catheterization | through study completion, an average of 52 weeks | |
| Secondary | Change from Baseline in average maximum catheterized volume per day | through study completion, an average of 52 weeks | |
| Secondary | Change from Baseline in average maximum catheterized daytime volume | through study completion, an average of 52 weeks |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05491525
GET https://conductscience.org/api/trials/v1/NCT05491525/registered