Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT03187795
Eligibility Criteria:
Inclusion Criteria:
* The subject has a neurological impairment secondary to a traumatic spinal cord injury that occurred at least twelve (12) months prior to the screening visit.
* The injury is classified as complete or incomplete (AIS grade A-D) and the neurological level of the injury is above T12.
* The subject's method of bladder management is intermittent catheterization (IC) or indwelling catheter (transurethral or suprapubic).
* There is urodynamic documentation of neurogenic detrusor overactivity (NDO).
* The subject is on a stable dose of oxybutynin IR three times daily.
* The subject is able and willing to comply with the study protocol, including availability for all scheduled clinic visits and locomotor training sessions.
* The subject is able to and has voluntarily given informed consent prior to the performance of any study-specific procedures.
Exclusion Criteria:
* The subject has taken mirabegron within one month of the Screening Visit.
* The subject has received a botulinum toxin injection to the bladder within one year of the Screening Visit.
* The subject is allergic to mirabegron.
* The subject has a history of uncontrolled autonomic dysreflexia or significant autonomic dysreflexia on urodynamics (systolic BP≥150 mm/Hg).
* The subject has a known history of significant anatomical problems of the upper tracts, including hydronephrosis, kidney stones, or ureteropelvic junction obstruction.
* The subject has a known history or treatment for a non-neurogenic bladder or prostate problem (prostate cancer, bladder cancer).
* The subject has recurrent UTIs, defined as a UTI more than every three months.
* The subject has untreated Grade 3 or above vesicoureteral reflux.
* If female, the subject is pregnant (documented by a urine pregnancy test) or breastfeeding.
* The subject has taken another investigational drug within 30 days before screening.
* The subject has a medical condition that might pose a safety issue or would interfere with interpretation of study results or study conduct.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03187795
Study Brief:
Protocol Section:
NCT03187795