Efficacy and Tolerability of Mirabegron Compared to Oxybutynin Chloride Immediate Release for Neurogenic Detrusor Overactivity in Persons With Chronic Spinal Cord Injury: A Randomized, Double-Blind, Controlled, Cross-Over Clinical Trial

Who is this study for? Patients with chronic spinal cord injury
What treatments are being studied? Oxybutynin Chloride+Mirabegron
Status: Unknown status
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: No
View:

• 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.

Locations
United States
New Jersey
Kessler Institute for Rehabilitation
Recruiting
West Orange
Contact Information
Primary
Todd A. Linsenmeyer, M.D.
tlinsenmeyer@kessler-rehab.com
973-243-6924
Backup
Trevor A. Dyson-Hudson, M.D.
tdysonhudson@kesslerfoundation.org
973-324-3576
Time Frame
Start Date: April 3, 2019
Completion Date: March 30, 2022
Participants
Target number of participants: 62
Treatments
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
Authors
Steven C. Kirshblum, Trevor A. Dyson-Hudson, Todd A. Linsenmeyer
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
Leads: Kessler Foundation

This content was sourced from clinicaltrials.gov

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