CompletedPhase 4MS (type not specified)NCT02086188

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Mirabegron

    Beta-3 adrenergic receptor agonist

Placebo or sham

  • Placebo

Results by group

Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit

10 weeks

GroupValueIntervalNumber analysed
Mirabegron3.01 score on a scale0.48 (Standard Deviation)14
Placebo2.56 score on a scale0.84 (Standard Deviation)14

Mirabegron

3.01

Placebo

2.56

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Mirabegron140 (0.0%)0
Placebo140 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit

    10 weeks

    Bladder, bowel and sexual function

Other measures (6)

  • Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Titration Visit

    5 weeks

    Bladder, bowel and sexual function
  • Mean # of Micturitions/Day Based on Voiding Diaries

    10 weeks

    Bladder, bowel and sexual function
  • Mean # of Incontinence Episodes/Day

    10 weeks

    Bladder, bowel and sexual function
  • Mean Volume Voided/Micturition

    10 weeks

    Bladder, bowel and sexual function
  • Qualiveen Questionnaire

    10 weeks

    Bladder, bowel and sexual function
  • Subject Global Impression (Single Question)

    10 weeks

    Bladder, bowel and sexual function

Who could take part

MS (type not specified) · 18 and over

Inclusion Criteria: * Confirmed diagnosis of Multiple Sclerosis (MS) (no sub-type restrictions) * Age ≥18 * No change in disease modifying therapy in 60 days. * Patient willing and able to complete micturition diary * Urinary urgency (8 or more entries of bladder urgency score ≥2) in 72hr voiding diary recorded during screening period * Micturition frequency ≥ 8 / day or incontinence ≥ 2 episodes in 72 hour voiding diary recorded during screening period * At least 36 hours of voiding activity recorded in 72 hour voiding diary during screening period * Non-antimuscarinic medications that are likely to influence bladder function may not be initiated between screening and study completion. They may be continued with no dose changes during the study. * Discontinued use of antimuscarinics at least two weeks prior to screening * Able to give informed consent Exclusion Criteria: * Females who are breast-feeding, pregnant or have potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures) * Multiple Sclerosis exacerbation within 30 days of screening * Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing * Screening blood pressure > 165 systolic or 100 diastolic * History of allergy to Mirabegron * Screening post-void residual > 200ml * Evidence of urinary tract infection at screening * Evidence of chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs * Intravesical botulinum toxin treatment within the previous six months of screening. * Presence of InterStim device * Use of indwelling catheter or self-catheterization * Concurrent use of thioridazine(Mellaril® or Mellaril-S®, flecainide (Tambocor®), propafenone (Rythmol®) or digoxin (Lanoxin®) * Concurrent use of antimuscarinics: oxybutynin (Ditropan®, Ditropan XL ®), tolterodine (Detrol®, Detrol LA®), fesoterodine extended-release (Toviaz®), solifenacin (Vesicare®), trospium (Sanctura®, Sanctura XR®), darifenacin extended release (Enablex®) * Screening estimated glomerular filtration rate (eGFR) \< 60, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal * Any other serious and/or unstable medical condition

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The purpose of this study is to determine if treatment with Mirabegron will improve urinary urgency control beyond that achieved with pelvic floor exercises alone

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History

    1. Started

      May 2014

    2. Main results due

      Apr 2019

    3. Finished

      Jun 2019

    4. Results posted

      Oct 2023

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