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Spinal Cord InjuriesEarly Phase 1SCIMYRNCT03612401

Treatment of Spinal Cord Injury Patients for Neurogenic Bladder: Anticholinergic Agent vs. Mirabegron

A Early Phase 1 study testing Mirabegron in people with Spinal Cord Injuries and Neurogenic Bladder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

We propose to test the hypothesis that cognition will improve with substitution of mirabegron for the anticholinergic agent (AC) in elderly persons with spinal cord injury (SCI) who require neurogenic bladder (NGB) treatment. Read more about this study

Who is it for?
Ages 60 to 99 years
What is being tested?
Mirabegron
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
5 Dec 2018to 31 Mar 2021
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Both genders with spinal cord injury being treated for neurogenic bladder and age >60 years
  • All ethnic groups
  • Veterans will be enrolled to allow mailing of study medication by VA pharmacies.
  • Laboratory results:
  • Normal clinical labs for CBC (complete blood count), CMP (comprehensive metabolic panel), and UA (urinalysis) within past 6 months or repeat at screening if none. For example: HCT (hematocrit) ≥34%, GFR (glomerular filtration rate) ≥ 30 mL/min, liver enzymes (AST (aspartate aminotransferase test) < 2 x upper limit of normal, ALT (alanine aminotransferase test) < 2 x upper limit of normal, alkaline phosphatase < 2 X upper limit of normal), normal electrolytes, urinalysis and asymptomatic for UTI (urinary tract infection)
  • Taking a minimum regimen for 3 months of anticholinergic agent.

Who cannot join

  • Diagnosis of dementia or cognitive impairment from another condition such as TBI (traumatic brain injury), ALZ (alzheimers), Lewy body dementia or vascular dementia
  • End stage renal disease (GFR <30) or bladder obstruction
  • Poorly controlled blood pressure (BP), systolic BP>180, diastolic BP>110 mmHg)
  • Renal function - exclude if serum creatinine >2x normal range
  • Liver function - exclude if >2x normal liver enzyme levels
  • History of, or currently active treatment for cardiac dysrhythmias, including atrial fibrillation (eg. apixaban. If subject is currently taking metoprolol they will be monitored and dose may need to be adjusted on mirabegron)
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  • Current treatment with desipramine, digoxin
  • Active/unstable conditions: inflammatory, thyroid, autoimmune, gastrointestinal (GI), hematologic, or neoplastic disorders. Exclude subjects with clinical lab values outside the normal range (other than as specified above).
  • Subject is considered unsuitable for the study in the opinion of the investigator for any other reason

Trial locations and contacts

1 site in 1 country.

United States1 site

  • South Texas Veterans Health Care System, Audie L. Murphy Hospital

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Treatment of Spinal Cord Injury Patients for Neurogenic Bladder: an Open Label Pilot Study of Anticholinergic Agent vs. Mirabegron (MYRBETRIQ ®) to Evaluate Cognitive Impact and Efficacy

We propose to test the hypothesis that cognition will improve with substitution of mirabegron for the anticholinergic agent (AC) in elderly persons with spinal cord injury (SCI) who require neurogenic bladder (NGB) treatment.

Read the detailed description

The strong evidence for detrimental effects of AC agents on cognition, led the American Urological Association to update its guidelines in 2015 to include mirabegron as an alternative first-line agent for treatment of overactive bladder (OAB). NGB symptoms are very similar to OAB so the conditions are often treated similarly; however, data is lacking on the use of this promising agent for NGB. We thus propose to test the hypothesis that cognition will improve with substitution of mirabegron for the AC agent in elderly persons with SCI who require NGB treatment.

Subjects eligible for enrollment will have been treated with an anticholinergic agent for at least 3 months prior to enrollment. Baseline measurements will be recorded for subjects currently treated with an AC agent, after enrollment, the subject will start treatment with the study drug. Measurements from baseline (AC agent) will be compared to measurements taken after study intervention (mirabegron).

Being tested
Mirabegron
Keywords
Spinal cord injury, SCI, Neurogenic bladder, Overactive bladder, anticholinergic, mirabegron, cognitive, cognition, NGB, OAB
Medical subject headings
Spinal Cord Injuries, Urinary Bladder, Neurogenic, Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MirabegronDrug

    Also called MYRBETRIQ

    Beta-3 adenoreceptor agonist

Study groups in NCT03612401
Study groupRoleWhat they receive
Neurogenic BladderOtherSpinal Cord Injury patients with known neurogenic bladder on treatment with Anticholinergic Agents at baseline switched to mirabegron as the study intervention
Receives: Drug: Mirabegron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cognitive measure - Logical Memory I (Immediate) - baseline and post treatment with mirabegron

    Wechsler Memory Scale, 4th edition (WMS-IV) subtest

    Measured: Change from Week 0 to Week 26

Secondary outcomes (7)

  1. Change in cognitive measure of memory (SLUMS) - baseline and post treatment with mirabegron

    Saint Louis University Mental Status Exam (SLUMS) - a series of shapes and recall measures

    Measured: Change from Week 0 to Week 26

  2. Change in cognitive measure of executive function (Stroop test) - baseline and post treatment with mirabegron

    Stroop Color and Word Test - a series of color-word and picture-word tests of executive function

    Measured: Change from Week 0 to Week 26

  3. Change in cognitive measure of executive function (SDMT) - baseline and post treatment with mirabegron

    Symbol Digit Modalities Test - a series of symbols to assess executive function

    Measured: Change from Week 0 to Week 26

  4. Change in memory and executive function (TEXAS) - baseline and post treatment with mirabegron

    Texas Executive Assessment (TEXAS) - A series of short term recall measures

    Measured: Change from Week 0 to Week 26

  5. Change in Neurogenic Bladder Symptom Score (NBSS) - baseline and post treatment with mirabegron

    Neurogenic bladder symptom questionnaire

    Measured: Change from Week 0 to Week 26

  6. Change in Neurogenic Bowel Dysfunction Score (NBD) - baseline and post treatment with mirabegron

    Neurogenic bowel questionnaire

    Measured: Change from Week 0 to Week 26

  7. Change in cognitive measure - Logical Memory II (Delayed) - baseline and post treatment with mirabegron

    Wechsler Memory Scale, 4th edition (WMS-IV) subtest

    Measured: Change from Week 0 to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2018
  2. Study start5 Dec 2018
  3. Primary completion23 Mar 2020
  4. Study completion31 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label, pilot study comparing baseline measurement anticholinergic agent vs. study intervention mirabegron (MYRBETRIC ®) to evaluate cognitive impact and efficacy (SCIMYR)
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03612401
Sponsor's protocol ID
HSC20180376H
Acronym
SCIMYR
Status last verified
Jun 2021
First submitted
9 Jul 2018
Last updated
22 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Mirabegron in people with Spinal Cord Injuries and Neurogenic Bladder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cognitive measure - Logical Memory I (Immediate) - baseline and post treatment with mirabegron (time frame: Change from Week 0 to Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03612401.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.

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