Recruiting
Phase 2

Mirabegron & Oxybutynin

Sponsor:

Kessler Foundation

Code:

NCT03187795

Conditions

Spinal Cord Injuries

Urinary Bladder, Neurogenic

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Oxybutynin Chloride IR

Mirabegron

Study Details

Brief 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).

Conditions

Spinal Cord Injuries

Urinary Bladder, Neurogenic

Study ID

NCT03187795

Start date

Apr 3, 2019

Status verified date

Dec, 2019

Completion date

Mar 30, 2022

Anticipated

Primary completion date

Sep 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oxybutynin chloride IR then Mirabegron

Subjects randomized to this group will receive oxybutynin IR (5 mg three times daily) for 6 weeks. After the initial 6 weeks, subjects in this group will then be switched to an escalating dose of mirabegron for 6 weeks (25 mg once daily for 2 weeks, followed by 50 mg once daily for 4 weeks; Note: two placebo daily will be included with mirabegron once daily to match the frequency of dosing to oxybutynin IR three times daily).

experimental: Mirabegron then Oxybutynin chloride IR

Subjects randomized to this group will receive an escalating dose of mirabegron for 6 weeks (25 mg once daily for 2 weeks, followed by 50 mg once daily for 4 weeks; Note: two placebo daily will be included with mirabegron once daily to match the frequency of dosing to oxybutynin IR three times daily). After the initial 6 weeks, subjects in this group will then be switched to receive oxybutynin IR (5 mg three times daily) for 6 weeks

Interventions

Oxybutynin Chloride IR

Oxybutynin chloride immediate release (IR) 5 mg three times daily for 6 weeks

Mirabegron

Mirabegron 25 mg tablet once daily for 2 weeks, followed by mirabegron 50 mg once daily for 4 weeks (Note: Placebo twice daily will be included with mirabegron once daily to match the three-time daily dosing of oxybutynin IR in the other intervention).

Primary outcome measure

  • Change in cystometric bladder capacity during filing cystometry [ Time Frame: Week 6 and Week 12 ]

Central Contacts and Locations

Central contacts

Todd A. Linsenmeyer, M.D.

973-243-6924tlinsenmeyer@kessler-rehab.com

Trevor A. Dyson-Hudson, M.D.

973-324-3576tdysonhudson@kesslerfoundation.org

Locations

Kessler Institute for Rehabilitation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Todd A. Linsenmeyer, M.D.

973-243-6924tlinsenmeyer@kessler-rehab.com

Trevor A. Dyson-Hudson, M.D.

973-324-3576tdysonhudson@kesslerfoundation.org

Principal Investigator:

Todd A. Linsenmeyer, M.D.

More Information

Sponsor

Kessler Foundation

Last update posted

Dec 17, 2019

Last verified

Dec, 2019

Keywords

  • Spinal Cord Injuries
  • Randomized Controlled Trial
  • Neurogenic Bladder
  • Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2019-12-17.