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Beta-3 Adrenergic Agonist

Mirabegron for Spinal Cord Injury (MOSET-SCI Trial)

Phase 2

Waitlist Available

Led By Todd A. Linsenmeyer, 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

Approved for 5 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6 and week 12

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in cystometric bladder capacity during filing cystometry

Secondary study objectives

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 study objectives

Adverse Event Case Report Form

Side Effects Record

Side effects data

From 2019 Phase 4 trial • 28 Patients • NCT02086188

headache

asthma

diarrhea

gastritis

urinary tract infection

fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Mirabegron

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

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