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Tests treatment safety and results for Neurogenic Detrusor Overactivity
Official 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
ClinicalTrials.gov ID: NCT05491525
What this study is testing
What is Vibegron?
Vibegron is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for neurogenic detrusor overactivity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Male or female participants, age 2 years to \< 18 years and weighing at least 11 kg at the Screening Visit.
- Participant has been diagnosed with NDO due to one of the following: spinal dysraphism, which includes spina bifida (eg, myelomeningocele...
- Participant undergoes CIC at least 3 times per 24 hours (with the last CIC performed prior to going to sleep for the night) for at least 4 weeks...
You likely can't join if
- Participant has cerebral palsy, uncontrolled epilepsy, diabetes insipidus, or Stage 2 hypertension
- Participant has an active malignancy in the 12 months prior to the Screening Visit.
- Participant has been administered intravesical botulinum toxin within 9 months prior to the Screening Visit and should remain off this therapy during...
- Participant is taking digoxin or lithium within 10 days prior to Screening Visit or plans to start taking either during the study.
- Participant currently uses or plans to use a baclofen pump during the study.
- Participant has had urethral dilatation or urethral surgery in the 3 months prior to the Screening Visit.
See the full eligibility criteria
- Male or female participants, age 2 years to \< 18 years and weighing at least 11 kg at the Screening Visit.
- Participant has been diagnosed with NDO due to one of the following: spinal dysraphism, which includes spina bifida (eg, myelomeningocele, meningocele) and all forms of tethered cord; or acquired NDO from a spinal cord...
- Participant undergoes CIC at least 3 times per 24 hours (with the last CIC performed prior to going to sleep for the night) for at least 4 weeks prior to the Screening Visit.
- Participant has cerebral palsy, uncontrolled epilepsy, diabetes insipidus, or Stage 2 hypertension
- Participant has an active malignancy in the 12 months prior to the Screening Visit.
- Participant has been administered intravesical botulinum toxin within 9 months prior to the Screening Visit and should remain off this therapy during the study.
- Participant is taking digoxin or lithium within 10 days prior to Screening Visit or plans to start taking either during the study.
- Participant currently uses or plans to use a baclofen pump during the study.
- Participant has had urethral dilatation or urethral surgery in the 3 months prior to the Screening Visit.
- Participant has undergone bladder augmentation surgery.
- Participant has a known genitourinary condition (other than NDO) that may cause overactive contractions or incontinence (bladder exstrophy, urinary tract obstruction, urethral diverticulum or fistula) or bladder stones...
- Participant has an insufficient urethral sphincter, has had implantation of an artificial sphincter, has a surgically-treated underactive urethral sphincter, or, in the 6 months prior to the Screening Visit, has...
- Participant has one of the following gastrointestinal problems: partial or complete obstruction, decreased motility such as paralytic ileus, risk of gastric retention, or malabsorption syndrome of any form.
- Participant has acute fecal impaction or, within the 3 months prior to the Screening Visit, had fecal impaction that required hospitalization or ambulatory surgical treatment.
- Participant had a urinary indwelling catheter in the 4 weeks prior to the Screening Visit.
- Participant has moderate to severe dilating vesicoureteral reflux (Grade IV to V) or severe renal failure.
- Participant started electrostimulation/neuromodulation therapy in the 4 weeks before the Screening Visit, or is expected to start this therapy during the study period.
- Participant has participated in another clinical trial and/or has taken an investigational drug within 4 weeks prior to the Screening Visit.
- Participant is unable, or parent/caregiver is not willing, to washout any medication for the management of NDO.
- Participant is a female of childbearing potential who is unwilling or unable to use a highly effective method of contraception for the duration of the study.
- Female participants who are currently breastfeeding or plan to breastfeed any time from the Screening Visit until 28 days after the final study drug administration.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Orange, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Wichita, Kansas, United States
- New Orleans, Louisiana, United States
- Albany, New York, United States
- Syracuse, New York, United States
- Durham, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- Edegem, Antwerpen, Belgium
- Ghent, East Flanders, Belgium
- Calgary, Alberta, Canada
- Toronto, Ontario, Canada
- Split, Croatia
- Aarhus, Denmark
- Tbilisi, Georgia
- Amman, Jordan
- Irbid, Jordan
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Orange, California, United States; Aurora, Colorado, United States; Jacksonville, Florida, United States; Wichita, Kansas, United States; New Orleans, Louisiana, United States and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.