Actively Recruiting
A Study of Vibegron in Pediatric Participants 2 Years to Less Than (<) 18 Years of Age With NDO and on CIC
Led by Urovant Sciences GmbH · Updated on 2024-07-03
85
Participants Needed
6
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Vibegron in Pediatric Participants 2 Years to Less Than (<) 18 Years of Age With NDO and on CIC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 2 years to under 18 years at screening
- Participants aged 12 to under 18 years must weigh at least 29.5 kg
- Participants aged 2 to under 12 years must weigh at least 11 kg
- Diagnosed with neurogenic detrusor overactivity due to spinal dysraphism, spinal cord injury/surgery (at least 6 months prior), or transverse myelitis (diagnosed at least 12 months prior)
- Performing clean intermittent catheterization at least 3 times per day for at least 4 weeks prior to screening
You will not qualify if you...
- Cerebral palsy, uncontrolled epilepsy, diabetes insipidus, or Stage 2 hypertension
- Active malignancy within 12 months prior to screening
- Intravesical botulinum toxin treatment within 9 months prior to screening
- Taking or planning to take digoxin or lithium within 10 days prior to screening or during the study
- Current or planned use of a baclofen pump during the study
- Urethral dilatation or urethral surgery within 3 months prior to screening
- History of bladder augmentation surgery
- Known genitourinary conditions other than NDO causing overactive contractions or incontinence
- Insufficient urethral sphincter or related surgeries including pelvic gender reassignment within 6 months prior to screening
- Gastrointestinal problems such as obstruction, decreased motility, gastric retention risk, or malabsorption syndrome
- Fecal impaction requiring hospitalization or surgery within 3 months prior to screening
- Use of urinary indwelling catheter within 4 weeks prior to screening
- Moderate to severe vesicoureteral reflux (Grade III to V) or severe renal failure
- Started or expected to start electrostimulation/neuromodulation therapy within 4 weeks prior to screening or during the study
- Participation in another clinical trial or investigational drug use within 4 weeks prior to screening
- Unable or unwilling to wash out any medication for NDO management
- Female of childbearing potential unwilling or unable to use highly effective contraception during the study
- Female currently breastfeeding or planning to breastfeed from screening until 28 days after last study drug dose
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Children's Hospital of Orange County
Orange, California, United States, 92868-4568
Actively Recruiting
2
Nemours Childrens Health, Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
3
Wichita Urology Group
Wichita, Kansas, United States, 67226
Actively Recruiting
4
Childrens Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Actively Recruiting
5
Albany Medical College
Albany, New York, United States, 12208
Actively Recruiting
6
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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