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Beta-3 Adrenergic Agonist

Mirabegron for Spinal Cord Injury (MOSET-SCI Trial)

Phase 2
Waitlist Available
Led By Trevor A. Dyson-Hudson, M.D.
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6 and week 12
Awards & highlights

MOSET-SCI Trial Summary

This trial will compare the effectiveness of two drugs for treating neurogenic detrusor overactivity, a bladder condition caused by spinal cord injury.

Eligible Conditions
  • Spinal Cord Injury
  • Neurogenic Bladder

MOSET-SCI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6 and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cystometric bladder capacity during filing cystometry
Secondary outcome measures
Change in California Verbal Learning Test - II (CVLT) scores
Change in Clinician Global Impression (CGI) of Change score
Change in Qualiveen scores
+10 more
Other outcome measures
Adverse Event Case Report Form
Side Effects Record

Side effects data

From 2019 Phase 4 trial • 28 Patients • NCT02086188
7%
urinary tract infection
7%
asthma
7%
gastritis
7%
fatigue
7%
diarrhea
7%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Mirabegron

MOSET-SCI Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirabegron
FDA approved

Find a Location

Who is running the clinical trial?

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
71 Previous Clinical Trials
9,067 Total Patients Enrolled
Kessler FoundationLead Sponsor
173 Previous Clinical Trials
10,646 Total Patients Enrolled
Trevor A. Dyson-Hudson, M.D.Principal InvestigatorKessler Foundation
5 Previous Clinical Trials
203 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Mirabegron and Oxybutynin Safety and Efficacy Trial in Spinal Cord Injury
Trevor Dyson-Hudson, M.D. 2019. "Mirabegron and Oxybutynin Safety and Efficacy Trial in Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03187795.
All > Spinal Cord
~10 spots leftby Apr 2025
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