Mirabegron and Oxybutynin Safety and Efficacy Trial in Spinal Cord Injury

• Status: Recruiting
• Trial end date: 2022-03-30
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kessler Foundation
• Collaborator: National Institute on Disability, Independent Living, and Rehabilitation Research
• Treatments: Mandelic Acids; Mirabegron; Oxybutynin

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.