Mirabegron for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Spinal Cord Injury+1 MoreMirabegron - Drug
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study 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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: Week 6 and Week 12

Week 12
Adverse Event Case Report Form
Side Effects Record
Screening Visit
Wechsler Test of Adult Reading (WTAR) score
Week 12
Change in California Verbal Learning Test - II (CVLT) scores
Change in Clinician Global Impression (CGI) of Change score
Change in Qualiveen scores
Change in SCI-QOL Bowel & Bladder Management Difficulties scores
Change in Subject Global Impression (SGI) of Change score
Change in Symbol Digit Modalities Test oral version (SDMT) scores
Change in bladder compliance during filling cystometry
Change in cystometric bladder capacity during filing cystometry
Change in detrusor leak point pressure
Change in maximum detrusor pressure
Change in post-void residual volume
Change on Bowel Function Measures - International SCI Bowel Function Basic & Extended Data Sets
Change on International Lower Urinary Tract Function Basic Spinal Cord Injury (SCI) Data Set

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Mirabegron
20%Constipation
13%Fatigue
13%loose stools
13%urinary incontinence
7%Diarrhea
7%Sore throat
7%Hallucinations
7%headache
7%abdominal cramps
7%Heart palpitations
7%Dysphagia
7%Hypertension
7%foot or knee pain
7%Dizziness
7%sinus infection
7%Erectile dysfunction
7%edema
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT02092181) in the Mirabegron ARM group. Side effects include: Constipation with 20%, Fatigue with 13%, loose stools with 13%, urinary incontinence with 13%, Diarrhea with 7%.

Trial Design

2 Treatment Groups

Oxybutynin chloride IR then Mirabegron
1 of 2
Mirabegron then Oxybutynin chloride IR
1 of 2

Experimental Treatment

62 Total Participants · 2 Treatment Groups

Primary Treatment: Mirabegron · No Placebo Group · Phase 2

Oxybutynin chloride IR then MirabegronExperimental Group · 2 Interventions: Oxybutynin Chloride IR, Mirabegron · Intervention Types: Drug, Drug
Mirabegron then Oxybutynin chloride IRExperimental Group · 2 Interventions: Oxybutynin Chloride IR, Mirabegron · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirabegron
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 6 and week 12

Who is running the clinical trial?

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
56 Previous Clinical Trials
6,866 Total Patients Enrolled
Kessler FoundationLead Sponsor
155 Previous Clinical Trials
10,253 Total Patients Enrolled
Todd A. Linsenmeyer, M.D.Principal InvestigatorKessler Institute for Rehabilitation
Steven C. Kirshblum, M.D.Principal InvestigatorKessler Institute for Rehabilitation
2 Previous Clinical Trials
67 Total Patients Enrolled
Trevor A. Dyson-Hudson, M.D.Principal InvestigatorKessler Foundation
5 Previous Clinical Trials
203 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The subject is taking oxybutynin IR three times a day in a stable dosage.
The subject has been made aware of any study-specific procedures, and has consented to having them performed.
The subject has a neurological impairment caused by a traumatic spinal cord injury that happened at least twelve (12) months before the screening visit.
The subject either uses intermittent catheterization (IC) or an indwelling catheter (transurethral or suprapubic) to manage their bladder.
The subject is able to comply with the study protocol, including availability for all scheduled clinic visits and locomotor training sessions.
The injury is classified as a complete or incomplete spinal cord injury and the neurological level of the injury is above T12.
There is evidence of neurogenic detrusor overactivity in the urodynamic records.