Mirabegron and Oxybutynin Safety and Efficacy Trial in Spinal Cord Injury

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Spinal Cord Injuries, Urinary Bladder, Neurogenic

In brief

The purpose of this research study is to determine the effectiveness and safety of mirabegron compared to oxybutynin chloride immediate release (oxybutynin IR) for a condition called neurogenic detrusor overactivity in individuals with chronic spinal cord injury (SCI).

Key facts

Study ID

NCT03187795

Run by

Kessler Foundation

People needed

62

Starts

2019-04-03

Expected to finish

2022-03-30

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kessler Institute for Rehabilitation — West Orange, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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