Mirabegron and Oxybutynin Safety and Efficacy Trial in Spinal Cord Injury (MOSET-SCI Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByTodd A. Linsenmeyer, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Kessler Foundation

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 Criteria

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Oxybutynin chloride IR then MirabegronExperimental Treatment2 Interventions

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).

Group II: Mirabegron then Oxybutynin chloride IRExperimental Treatment2 Interventions

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

Mirabegron is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Myrbetriq for: