An Early Phase 1 interventional study of Mirabegron in Spinal Cord Injuries, Neurogenic Bladder and Cognitive Change, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 60 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-06-22.
Sponsored by The University of Texas Health Science Center at San Antonio · Early Phase 1, Interventional, and Treatment
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.
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).
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 20 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion Criteria:
Spinal Cord Injury patients with known neurogenic bladder on treatment with Anticholinergic Agents at baseline switched to mirabegron as the study intervention
Drug: Mirabegron
Beta-3 adenoreceptor agonist
Also known as: MYRBETRIQ
Change in cognitive measure - Logical Memory I (Immediate) - baseline and post treatment with mirabegron
Wechsler Memory Scale, 4th edition (WMS-IV) subtest
Time frame: Change from Week 0 to Week 26
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
Time frame: Change from Week 0 to Week 26
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
Time frame: Change from Week 0 to Week 26
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
Time frame: Change from Week 0 to Week 26
Change in memory and executive function (TEXAS) - baseline and post treatment with mirabegron
Texas Executive Assessment (TEXAS) - A series of short term recall measures
Time frame: Change from Week 0 to Week 26
Change in Neurogenic Bladder Symptom Score (NBSS) - baseline and post treatment with mirabegron
Neurogenic bladder symptom questionnaire
Time frame: Change from Week 0 to Week 26
Change in Neurogenic Bowel Dysfunction Score (NBD) - baseline and post treatment with mirabegron
Neurogenic bowel questionnaire
Time frame: Change from Week 0 to Week 26
Change in cognitive measure - Logical Memory II (Delayed) - baseline and post treatment with mirabegron
Wechsler Memory Scale, 4th edition (WMS-IV) subtest
Time frame: Change from Week 0 to Week 26
Plan to share: No
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio