The purpose of this study is to evaluate blood levels of solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after taking a single oral dose. If the bladder contracts strongly and without warning, the muscles surrounding the urethra (detrusor muscles) may not be able to keep urine from passing. This may happen as a consequence of spinal cord defects, and then is called neurogenic detrusor overactivity.
Who can participate
Age range
5 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented diagnosis of NDO, confirmed by urodynamics
* Weight and height are within normal percentiles (3rd to 97th percentile) according to Centers for Disease Control and Prevention (CDC) growth charts
* Subject's bowel function is being actively managed
* Able to swallow the study medication in accordance to the protocol
* Female subjects of childbearing potential and sexually active agree to use a reliable form of birth control for the duration of the study and for at least one month after ending study treatment. Sexually active male subjects agree to use a barrier method of birth control for the duration of the study and for at least one month after ending study treatment
* Subject and subject's parent(s)/legal guardian are willing and able to comply with the study requirements and with the concomitant medication restrictions
Exclusion Criteria:
At screening:
* Subject is breastfeeding or pregnant. Subjects of childbearing potential must have a negative serum pregnancy test
* Subject with any of the following gastrointestinal (GI)conditions: partial or complete bowel obstruction, decreased motility (e.g., paralytic ileus) or at risk for gastric retention
* Current fecal impaction or history of hospitalization for fecal impaction with enema in the past 2 years
* History of QTc prolongation or risk of QT prolongation (e.g., hypokalemia, family history of Long QT Syndrome \[LQTS\]). QT interval greater than 470 ms at baseline
* Any clinically sign…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum concentration (Cmax)
Timeframe: Day 1 predose up to Day 7 postdose
2
Time to Attain Cmax (tmax)
Timeframe: Day 1 predose up to Day 7 postdose
3
Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf)
Timeframe: Day 1 predose up to Day 7 postdose
4
Apparent Terminal Elimination Half-life (t1/2)
Timeframe: Day 1 predose up to Day 7 postdose
5
Apparent Total Body Clearance (CL/F)
Timeframe: Day 1 predose up to Day 7 postdose
6
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Timeframe: Day 1 predose up to Day 7 postdose
7
Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)