Multiple SclerosisPhase 4MIRRORNCT02086188
Study of Behavioral Modification Program and Mirabegron to Improve Urinary Urgency in Multiple Sclerosis
A Phase 4 study testing Mirabegron in people with Multiple Sclerosis, run by Theodore R. Brown, MD MPH at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Mirabegron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jun 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
EvergreenHealth MS Center
Kirkland, Washington, 98034
About this study
Official title: Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Multiple Sclerosis (MIRROR)
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
Read the detailed description
A randomized 1:1 placebo controlled 10-week study of mirabegron as add-on therapy to an educational intervention on behavioral modification including pelvic floor exercise (BM-PFE) to a cohort of 40 Multiple Sclerosis (MS) subjects with overactive bladder (OAB). Trial will last approximately 12 weeks for each subject, including screening period and treatment period.
Active drug will be mirabegron 25mg daily with optional up-titration to 50mg daily after approximately 5 weeks. Subjects will be randomized at the Baseline Visit based on recordings in a voiding diary kept for 72 continuous hours in the screening period.
Voiding diaries of a 72 hour period each will be utilized during the screening period, between Phone Visit 1 and Titration and between Phone Visit 2 and Final Visit. In the diaries, subjects will record the time of each micturition and/or urgency episode, urine volume with each void (when available), any episode of incontinence, and the severity of urgency (Overactive Bladder Symptom Composite Score, mean of 72 hour total daily cumulative score.
Primary outcome will be average daily OAB-SCS total score, Final Visit vs. Baseline. This accounts for the frequency, urgency and incontinence components of OAB.
- Conditions
- Multiple Sclerosis
- Being tested
- Mirabegron, Placebo
- Keywords
- Multiple Sclerosis, Overactive Bladder, Incontinence, Voiding, Bladder Urgency, Pelvic Floor Exercises
- Medical subject headings
- Multiple Sclerosis, 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 MBG, Myrbetriq
see detailed information in associated Arm Description
PlaceboDrug
Sugar pill manufactured to mimic Mirabegron 25mg tablet.
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron | Experimental | Mirabegron - 25mg (one tablet) taken by mouth daily with option to up-titrate to 50mg daily (two tablets) taken by mouth daily Receives: Drug: Mirabegron |
| Placebo | Placebo comparator | Placebo - one tablet taken by mouth daily and two tablets taken by mouth daily if subject chooses up-titration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit
Primary outcome: Overactive Bladder Symptom Composite Score (OAB-SCS) total score, average daily, Baseline vs. Final Visit The OAB-SCS measures symptoms of overactive bladder, urgency, frequency, incontinence. This is an ordinal scale is 1-5, 1 (minimum) = no urgency, 5 (maximum) = urgency incontinence.
Higher values represent a worse outcome.
Measured: 10 weeks
Secondary outcomes (6)
Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Titration Visit
Secondary Outcome Measure based on voiding diary: Average daily Overactive Bladder Symptom Composite Score (OAB-SCS) Baseline compared to Titration Visit The OAB-SCS measures symptoms of overactive bladder, urgency, frequency, incontinence. This is an ordinal scale is 1-5, 1 (minimum) = no urgency, 5 (maximum) = urgency incontinence.
Higher values represent a worse outcome.
Measured: 5 weeks
Mean # of Micturitions/Day Based on Voiding Diaries
Secondary Outcome Measure based on voiding diary:
Baseline vs Final Visit: mean # of micturitions/day
Measured: 10 weeks
Mean # of Incontinence Episodes/Day
Secondary Outcome Measure based on voiding diary:
Baseline vs. Final Visit: Mean # of incontinence episodes/day
Measured: 10 weeks
Mean Volume Voided/Micturition
Secondary Outcome Measure based on voiding diary:
Baseline vs. Final Visit: Mean volume voided/micturition
Measured: 10 weeks
Qualiveen Questionnaire
Secondary Outcome Measures based on the Qualiveen Questionnaire at Final Visit compared to Baseline Qualiveen questionaire is used, including 8 questions about aspects of bladder problems. Each question is rated 0 (not at all)- 4 (extremely). Overall score is averaged (average score per question)
Measured: 10 weeks
Subject Global Impression (Single Question)
Secondary Outcome Measures based on the Subject Global Impression (single question) at Final Visit compared to Baseline This is a single question: "How would you rate your level of bladder control during the past week?" 1-7 analog scale, 1 = "terrible'" 7 = "delighted."
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodore R. Brown, MD MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor-investigator, Theodore R. Brown, MD MPH, EvergreenHealth
- Investigators
- Theodore R Brown, MD, MPH, Principal investigator, EvergreenHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086188
- Sponsor's protocol ID
- TRB2013
- Acronym
- MIRROR
- Status last verified
- Sep 2023
- First submitted
- 11 Mar 2014
- Last updated
- 18 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Multiple Sclerosis (MIRROR)
- ClinicalTrials.gov ID
- NCT02086188
- Acronym / sponsor ID
- MIRROR / TRB2013
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Overactive Bladder, Incontinence, Voiding, Bladder Urgency, Pelvic Floor Exercises
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Theodore R. Brown, MD MPHUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- May 2014 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Posted 18 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
A randomized 1:1 placebo controlled 10-week study of mirabegron as add-on therapy to an educational intervention on behavioral modification including pelvic floor exercise (BM-PFE) to a cohort of 40 Multiple Sclerosis (MS) subjects with overactive bladder (OAB). Trial will last approximately 12 weeks for each subject, including screening period and treatment period.
Active drug will be mirabegron 25mg daily with optional up-titration to 50mg daily after approximately 5 weeks. Subjects will be randomized at the Baseline Visit based on recordings in a voiding diary kept for 72 continuous hours in the screening period.
Voiding diaries of a 72 hour period each will be utilized during the screening period, between Phone Visit 1 and Titration and between Phone Visit 2 and Final Visit. In the diaries, subjects will record the time of each micturition and/or urgency episode, urine volume with each void (when available), any episode of incontinence, and the severity of urgency (Overactive Bladder Symptom Composite Score, mean of 72 hour total daily cumulative score.
Primary outcome will be average daily OAB-SCS total score, Final Visit vs. Baseline. This accounts for the frequency, urgency and incontinence components of OAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirabegron | Experimental | Drug: MirabegronMirabegron - 25mg (one tablet) taken by mouth daily with option to up-titrate to 50mg daily (two tablets) taken by mouth daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo - one tablet taken by mouth daily and two tablets taken by mouth daily if subject chooses up-titration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirabegronAlso: MBG, Myrbetriqsee detailed information in associated Arm Description | Drug | Mirabegron |
| PlaceboSugar pill manufactured to mimic Mirabegron 25mg tablet. | Drug | Placebo |
Primary outcome
Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit
Time frame: 10 weeks
Primary outcome: Overactive Bladder Symptom Composite Score (OAB-SCS) total score, average daily, Baseline vs. Final Visit The OAB-SCS measures symptoms of overactive bladder, urgency, frequency, incontinence. This is an ordinal scale is 1-5, 1 (minimum) = no urgency, 5 (maximum) = urgency incontinence. Higher values represent a worse outcome.
6 secondary outcomes
Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Titration Visit
Time frame: 5 weeks
Mean # of Micturitions/Day Based on Voiding Diaries
Time frame: 10 weeks
Mean # of Incontinence Episodes/Day
Time frame: 10 weeks
Mean Volume Voided/Micturition
Time frame: 10 weeks
Qualiveen Questionnaire
Time frame: 10 weeks
Subject Global Impression (Single Question)
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore R Brown, MD, MPH principal investigator
EvergreenHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirabegron in people with Multiple Sclerosis, run by Theodore R. Brown, MD MPH 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 10 inclusion and 15 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 18 Oct 2023. 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. Some participants in this study may receive a placebo. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overactive Bladder Symptom Composite Score (OAB-SCS) at Baseline vs. Final Visit (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2023.