Phase 3 Transverse Myelitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The participant must be a child or teenager between 2 and under 18 years old, and must weigh at least 11 kg (about 24 lbs) at the screening appointment.
• The participant must have been diagnosed with neurogenic detrusor overactivity (a bladder control condition caused by nerve problems) due to a spinal birth defect such as spina bifida, OR due to a spinal cord injury or spinal cord surgery that happened at least 6 months ago, OR due to a condition called transverse myelitis diagnosed at least 12 months ago.
• The participant must use a catheter to empty their bladder (called "clean intermittent catheterisation") at least 3 times every 24 hours, including before going to sleep at night, and must have been doing this for at least 4 weeks before the screening appointment.

Who may not be able to join:

• The participant has cerebral palsy, epilepsy that is not well controlled, diabetes insipidus, or severely high blood pressure (Stage 2 hypertension).
• The participant has had an active cancer diagnosis in the 12 months before the screening appointment.
• The participant has received botulinum toxin (e.g. Botox) injected into the bladder within the past 9 months, or would need to continue this treatment during the study.
• The participant is currently taking or has taken the medications digoxin or lithium within 10 days before screening, or plans to take either during the study.
• The participant currently uses or plans to use a baclofen pump (a device that delivers medication for muscle spasms) during the study.
• The participant has had a procedure to widen or repair the urethra (the tube that carries urine out of the body) in the 3 months before screening.
• The participant has previously had surgery to enlarge the bladder (bladder augmentation surgery).
• The participant has another known bladder or urinary condition — besides the nerve-related bladder condition — that could cause bladder spasms, leaking, blockages, bladder stones, or other ongoing urinary problems.
• The participant has a urethral sphincter (the muscle that controls urine flow) that does not work properly, has had an artificial sphincter implanted, has had surgery to treat a weak sphincter, or has had pelvic gender reassignment surgery in the 6 months before screening.
• The participant has certain bowel problems, such as a blockage in the gut, slow or stopped bowel movement, risk of the stomach not emptying properly, or a condition that affects how the body absorbs nutrients.
• The participant currently has severe constipation with impacted stool (fecal impaction), or within the past 3 months needed hospital or surgical treatment for this problem.
• The participant has had a permanent catheter (a tube left in place in the bladder) in the 4 weeks before screening.
• The participant has a moderate to severe backflow of urine from the bladder to the kidneys (Grade IV or V vesicoureteral reflux) or severe kidney failure.
• The participant started electrical nerve stimulation therapy for their bladder within the 4 weeks before screening, or is expected to start this during the study.
• The participant has taken part in another clinical trial or taken an experimental drug within the 4 weeks before screening.
• The participant (or their parent/caregiver) is not willing or able to stop taking any current medications used to manage their bladder condition for the duration of the study.
• The participant is a girl or young woman who could become pregnant and is unwilling or unable to use a highly effective form of contraception throughout the study.
• The participant is a girl or young woman who is currently breastfeeding or plans to breastfeed at any time from the screening appointment until 28 days after the last dose of the study drug.

Important: Always verify eligibility with the trial site directly before applying.