Actively Recruiting
A Phase 2/3, Open-label, Long-term Study to Evaluate Safety, Efficacy, and Pharmacokinetics of Vibegron in Children 2 to <18 Years With Neurogenic Detrusor Overactivity on Clean Intermittent Catheterization
Led by Urovant Sciences GmbH · Updated on 2024-07-03
85
Participants Needed
6
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and how the body processes the drug vibegron in children aged 2 to less than 18 years who have neurogenic detrusor overactivity (NDO) and who regularly use clean intermittent catheterization (CIC). This study includes pediatric participants with NDO due to conditions like spinal dysraphism or acquired causes and aims to gather long-term safety and efficacy data. Participants are divided into two groups based on age: those aged 12 to less than 18 years and those aged 2 to less than 12 years. Both groups receive vibegron orally once daily, with doses adjusted according to weight and individual responses, including possible dose reductions up to two times. The study includes two parts: Part A involves initial dosing and monitoring, while Part B administers a dose selected by a safety board based on Part A data. Throughout the study, participants will be monitored with various assessments including bladder function tests, catheterized urine volume measurements, and questionnaires about incontinence and symptoms. These evaluations occur at multiple time points up to 52 weeks, with the primary outcome focused on changes in bladder capacity at 32 weeks. Safety and tolerability are also closely followed during the study, which may last several months for each participant.
CONDITIONS
Brief 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 to less than 18 years at screening
- Participants aged 12 to less than 18 years must weigh at least 29.5 kilograms
- Participants aged 2 to less than 12 years must weigh at least 11 kilograms
- 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
- Undergoing clean intermittent catheterization at least 3 times per 24 hours for at least 4 weeks prior to screening
You will not qualify if you...
- Diagnosis of cerebral palsy, uncontrolled epilepsy, diabetes insipidus, or Stage 2 hypertension
- Active malignancy within 12 months prior to screening
- Received intravesical botulinum toxin within 9 months prior to screening
- Taking or planning to take digoxin or lithium within 10 days prior to screening
- Current or planned use of a baclofen pump
- Urethral dilatation or urethral surgery within 3 months prior to screening
- History of bladder augmentation surgery
- Other genitourinary conditions causing overactive contractions or incontinence
- Insufficient urethral sphincter or surgeries related to sphincter or pelvic gender reassignment within 6 months
- Gastrointestinal issues like obstruction, decreased motility, or malabsorption
- Fecal impaction requiring hospitalization or surgery within 3 months prior
- Use of urinary indwelling catheter within 4 weeks prior
- Moderate to severe vesicoureteral reflux or severe renal failure
- Started or expected to start electrostimulation/neuromodulation therapy within 4 weeks prior
- Participation in another clinical trial or use of investigational drug within 4 weeks prior
- Unable or unwilling to washout medications for NDO management
- Female of childbearing potential unwilling or unable to use effective contraception during study
- Currently breastfeeding or planning to breastfeed from screening until 28 days after final drug administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive Vibegron orally once daily with dose adjustments based on individual clinical condition, pharmacokinetics, and safety/tolerability.
Regular visits at Baseline and Weeks 1, 4, 8, 20, 32, 48, and 52
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here