Spinal Cord InjuriesPhase 2MOSET-SCINCT03187795
Mirabegron and Oxybutynin Safety and Efficacy Trial in Spinal Cord Injury
A Phase 2 study testing Oxybutynin Chloride IR and Mirabegron in people with Spinal Cord Injuries and Urinary Bladder, Neurogenic, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this research study is to determine the effectiveness and safety of mirabegron compared to oxybutynin chloride immediate release (oxybutynin IR) for a condition called neurogenic detrusor overactivity in individuals with chronic spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Urinary Bladder, Neurogenic
- What is being tested?
- Oxybutynin Chloride IR and Mirabegron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2019to 30 Mar 2022
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has a neurological impairment secondary to a traumatic spinal cord injury that occurred at least twelve (12) months prior to the screening visit.
- The injury is classified as complete or incomplete (AIS grade A-D) and the neurological level of the injury is above T12.
- The subject's method of bladder management is intermittent catheterization (IC) or indwelling catheter (transurethral or suprapubic).
- There is urodynamic documentation of neurogenic detrusor overactivity (NDO).
- The subject is on a stable dose of oxybutynin IR three times daily.
- The subject is able and willing to comply with the study protocol, including availability for all scheduled clinic visits and locomotor training sessions.
- The subject is able to and has voluntarily given informed consent prior to the performance of any study-specific procedures.
Who cannot join
- The subject has taken mirabegron within one month of the Screening Visit.
- The subject has received a botulinum toxin injection to the bladder within one year of the Screening Visit.
- The subject is allergic to mirabegron.
- The subject has a history of uncontrolled autonomic dysreflexia or significant autonomic dysreflexia on urodynamics (systolic BP≥150 mm/Hg).
- The subject has a known history of significant anatomical problems of the upper tracts, including hydronephrosis, kidney stones, or ureteropelvic junction obstruction.
- The subject has a known history or treatment for a non-neurogenic bladder or prostate problem (prostate cancer, bladder cancer).
Show all 11Show fewer
- The subject has recurrent UTIs, defined as a UTI more than every three months.
- The subject has untreated Grade 3 or above vesicoureteral reflux.
- If female, the subject is pregnant (documented by a urine pregnancy test) or breastfeeding.
- The subject has taken another investigational drug within 30 days before screening.
- The subject has a medical condition that might pose a safety issue or would interfere with interpretation of study results or study conduct.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
Todd A. Linsenmeyer, M.D., 973-243-6924, tlinsenmeyer@kessler-rehab.com
Trevor A. Dyson-Hudson, M.D., 973-324-3576, tdysonhudson@kesslerfoundation.org
About this study
Official title: Efficacy and Tolerability of Mirabegron Compared to Oxybutynin Chloride Immediate Release for Neurogenic Detrusor Overactivity in Persons With Chronic Spinal Cord Injury: A Randomized, Double-Blind, Controlled, Cross-Over Clinical Trial
The purpose of this research study is to determine the effectiveness and safety of mirabegron compared to oxybutynin chloride immediate release (oxybutynin IR) for a condition called neurogenic detrusor overactivity in individuals with chronic spinal cord injury (SCI).
Read the detailed description
Neurogenic detrusor overactivity or "NDO" is common in people with spinal cord injury (SCI) and is a medical condition characterized by involuntary urinary bladder contractions. These bladder contractions can cause episodes of urinary incontinence (involuntary urine leakage) and/or high bladder pressures that can lead to poor drainage from the kidneys and urinary tract infections (UTIs).
Neurogenic detrusor overactivity is most commonly treated with a medication called oxybutynin (Ditropan); however, this medication is associated with side effects such as dry mouth and constipation. Mirabegron (Myrbetriq) is a newer medication approved by the Food and Drug Administration for the treatment of overactive bladder that does not cause dry mouth or constipation; however, its use in persons with SCI is investigational.
The purpose of this research study is to determine the effectiveness and safety of mirabegron compared to oxybutynin chloride immediate release (oxybutynin IR) for neurogenic detrusor overactivity in individuals with SCI.
- Conditions
- Spinal Cord Injuries, Urinary Bladder, Neurogenic
- Being tested
- Oxybutynin Chloride IR, Mirabegron
- Keywords
- Spinal Cord Injuries, Randomized Controlled Trial, Neurogenic Bladder, Rehabilitation
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxybutynin Chloride IRDrug
Also called Ditropan
Oxybutynin chloride immediate release (IR) 5 mg three times daily for 6 weeks
MirabegronDrug
Also called Myrbetriq
Mirabegron 25 mg tablet once daily for 2 weeks, followed by mirabegron 50 mg once daily for 4 weeks (Note: Placebo twice daily will be included with mirabegron once daily to match the three-time daily dosing of oxybutynin IR in the other intervention).
| Study group | Role | What they receive |
|---|---|---|
| Oxybutynin chloride IR then Mirabegron | Experimental | Subjects randomized to this group will receive oxybutynin IR (5 mg three times daily) for 6 weeks. After the initial 6 weeks, subjects in this group will then be switched to an escalating dose of mirabegron for 6 weeks (25 mg once daily for 2 weeks, followed by 50 mg once daily for 4 weeks; Note: two placebo daily will be included with mirabegron once daily to match the frequency of dosing to oxybutynin IR three times daily). Receives: Drug: Oxybutynin Chloride IR; Drug: Mirabegron |
| Mirabegron then Oxybutynin chloride IR | Experimental | Subjects randomized to this group will receive an escalating dose of mirabegron for 6 weeks (25 mg once daily for 2 weeks, followed by 50 mg once daily for 4 weeks; Note: two placebo daily will be included with mirabegron once daily to match the frequency of dosing to oxybutynin IR three times daily). After the initial 6 weeks, subjects in this group will then be switched to receive oxybutynin IR (5 mg three times daily) for 6 weeks Receives: Drug: Oxybutynin Chloride IR; Drug: Mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cystometric bladder capacity during filing cystometry
The cystometric bladder capacity is the bladder volume (ml) at the end of the filling cystometrogram, when 'permission to void' is usually given.
Measured: Week 6 and Week 12
Secondary outcomes (13)
Change in detrusor leak point pressure
The detrusor leak point pressure (cm H2O) is defined as the lowest detrusor pressure at which urine leakage occurs in the absence of either a detrusor contraction or increased abdominal pressure.
Measured: Week 6 and Week 12
Change in maximum detrusor pressure
Maximum detrusor pressure (ml/cm H2O) as the name implies, is the maximum detrusor pressure during filling cystometry.
Measured: Week 6 and Week 12
Change in bladder compliance during filling cystometry
Bladder compliance during filling cystometry (ml/cm H2O) is the relationship between change in bladder volume and change in detrusor pressure and is calculated by dividing the volume change (ΔV) by the change in detrusor pressure (Δρdet) during that change in bladder volume (C= ΔV/Δρdet).
Measured: Week 6 and Week 12
Change in post-void residual volume
The post-void residual volume (ml) is defined as the volume of urine left in the bladder at the end of micturition1 and is recommended as a core urodynamic outcome measure in SCI.
Measured: Week 6 and Week 12
Change on International Lower Urinary Tract Function Basic Spinal Cord Injury (SCI) Data Set
The purpose of the Lower Urinary Tract Function Basic Data Set for Spinal Cord Injury (SCI) individuals is to standardize the collection and reporting of information on the lower urinary tract and to make it possible to evaluate and compare results from various published studies.
Measured: Week 6 and Week 12
Change on Bowel Function Measures - International SCI Bowel Function Basic & Extended Data Sets
The International Bowel Function Basic and Extended SCI Data Sets present a standardized format for the collection and reporting of an extended amount of information on bowel function in persons with SCI.
Measured: Week 6 and Week 12
Change in California Verbal Learning Test - II (CVLT) scores
Memory will be assessed by the California Verbal Learning Test - II (CVLT). It consists of a list of 16 words from 4 semantic categories presented orally over 5 trials and includes a 20 minute delayed recall trial as well as a recognition trial.
Measured: Week 6 and Week 12
Change in Symbol Digit Modalities Test oral version (SDMT) scores
Processing speed will be assessed by the Symbol Digit Modalities Test oral version.
Measured: Week 6 and Week 12
Wechsler Test of Adult Reading (WTAR) score
The Wechsler Test of Adult Reading will be administered to provide an estimate of verbal intelligence for later use as a covariate in the analyses of the cognitive outcomes. The WTAR is composed of 50 irregularly spelled words and takes approximately 10 minutes to complete.
Measured: Screening Visit
Change in Qualiveen scores
The Qualiveen was developed as a condition-specific QOL measure for individuals with SCI. It consists of 30 items focusing on four aspects of individuals' lives related to their urinary problems: bother with limitations, frequency of limitations, fears, and feelings.
Measured: Week 6 and Week 12
Change in SCI-QOL Bowel & Bladder Management Difficulties scores
The SCI-QOL Bladder Management Difficulties and SCI-QOL Bowel Management Difficulties were developed as QOL measure for individuals with SCI and are part of the SCI-QOL measurement system.
Measured: Week 6 and Week 12
Change in Subject Global Impression (SGI) of Change score
The SGI of change is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale.
Measured: Week 6 and Week 12
Change in Clinician Global Impression (CGI) of Change score
The study physician will rate on a 7-point scale the subject's overall clinical condition following treatment as compared to that at baseline.
Measured: Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start3 Apr 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- After a two-day washout period, participants will be randomly assigned to one of two treatment groups: 1) an escalating dose of mirabegron for 6 weeks (25 mg once daily plus two placebo pills for 2 weeks, followed by 50 mg once daily plus 2 placebo pills for 4 weeks); or 2) Oxybutynin IR (5 mg orally three times daily) for 6 weeks. All participants will then be switched to the opposite study treatment for 6 weeks. Assessments will be performed at Baseline, Week 6 (completion of first study medication and prior to administration of second study medication), and Week 12 (completion of second study medication).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Trevor Dyson-Hudson, M.D., Kessler Foundation
- Investigators
- Todd A. Linsenmeyer, M.D., Principal investigator, Kessler Institute for RehabilitationSteven C. Kirshblum, M.D., Principal investigator, Kessler Institute for RehabilitationTrevor A. Dyson-Hudson, M.D., Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187795
- Sponsor's protocol ID
- D-961-17
- Acronym
- MOSET-SCI
- Status last verified
- Dec 2019
- First submitted
- 12 Jun 2017
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Mirabegron Compared to Oxybutynin Chloride Immediate Release for Neurogenic Detrusor Overactivity in Persons With Chronic Spinal Cord Injury: A Randomized, Double-Blind, Controlled, Cross-Over Clinical Trial
- ClinicalTrials.gov ID
- NCT03187795
- Acronym / sponsor ID
- MOSET-SCI / D-961-17
- Conditions
- Spinal Cord Injuries, Urinary Bladder, Neurogenic
- Keywords
- Spinal Cord Injuries, Randomized Controlled Trial, Neurogenic Bladder, Rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
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 research study is to determine the effectiveness and safety of mirabegron compared to oxybutynin chloride immediate release (oxybutynin IR) for a condition called neurogenic detrusor overactivity in individuals with chronic spinal cord injury (SCI).
Detailed description
Neurogenic detrusor overactivity or "NDO" is common in people with spinal cord injury (SCI) and is a medical condition characterized by involuntary urinary bladder contractions. These bladder contractions can cause episodes of urinary incontinence (involuntary urine leakage) and/or high bladder pressures that can lead to poor drainage from the kidneys and urinary tract infections (UTIs).
Neurogenic detrusor overactivity is most commonly treated with a medication called oxybutynin (Ditropan); however, this medication is associated with side effects such as dry mouth and constipation. Mirabegron (Myrbetriq) is a newer medication approved by the Food and Drug Administration for the treatment of overactive bladder that does not cause dry mouth or constipation; however, its use in persons with SCI is investigational.
The purpose of this research study is to determine the effectiveness and safety of mirabegron compared to oxybutynin chloride immediate release (oxybutynin IR) for neurogenic detrusor overactivity in individuals with SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- After a two-day washout period, participants will be randomly assigned to one of two treatment groups: 1) an escalating dose of mirabegron for 6 weeks (25 mg once daily plus two placebo pills for 2 weeks, followed by 50 mg once daily plus 2 placebo pills for 4 weeks); or 2) Oxybutynin IR (5 mg orally three times daily) for 6 weeks. All participants will then be switched to the opposite study treatment for 6 weeks. Assessments will be performed at Baseline, Week 6 (completion of first study medication and prior to administration of second study medication), and Week 12 (completion of second study medication).
| Arm | Type | Receives |
|---|---|---|
| Oxybutynin chloride IR then Mirabegron | Experimental | Drug: Oxybutynin Chloride IR, Drug: MirabegronSubjects randomized to this group will receive oxybutynin IR (5 mg three times daily) for 6 weeks. After the initial 6 weeks, subjects in this group will then be switched to an escalating dose of mirabegron for 6 weeks (25 mg once daily for 2 weeks, followed by 50 mg once daily for 4 weeks; Note: two placebo daily will be included with mirabegron once daily to match the frequency of dosing to oxybutynin IR three times daily). |
| Mirabegron then Oxybutynin chloride IR | Experimental | Drug: Oxybutynin Chloride IR, Drug: MirabegronSubjects randomized to this group will receive an escalating dose of mirabegron for 6 weeks (25 mg once daily for 2 weeks, followed by 50 mg once daily for 4 weeks; Note: two placebo daily will be included with mirabegron once daily to match the frequency of dosing to oxybutynin IR three times daily). After the initial 6 weeks, subjects in this group will then be switched to receive oxybutynin IR (5 mg three times daily) for 6 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject has a neurological impairment secondary to a traumatic spinal cord injury that occurred at least twelve (12) months prior to the screening visit.
- The injury is classified as complete or incomplete (AIS grade A-D) and the neurological level of the injury is above T12.
- The subject's method of bladder management is intermittent catheterization (IC) or indwelling catheter (transurethral or suprapubic).
- There is urodynamic documentation of neurogenic detrusor overactivity (NDO).
- The subject is on a stable dose of oxybutynin IR three times daily.
Key exclusion criteria (11 listed)
- The subject has taken mirabegron within one month of the Screening Visit.
- The subject has received a botulinum toxin injection to the bladder within one year of the Screening Visit.
- The subject is allergic to mirabegron.
- The subject has a history of uncontrolled autonomic dysreflexia or significant autonomic dysreflexia on urodynamics (systolic BP≥150 mm/Hg).
- The subject has a known history of significant anatomical problems of the upper tracts, including hydronephrosis, kidney stones, or ureteropelvic junction obstruction.
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 |
|---|---|---|
| Oxybutynin Chloride IRAlso: DitropanOxybutynin chloride immediate release (IR) 5 mg three times daily for 6 weeks | Drug | Mirabegron then Oxybutynin chloride IR, Oxybutynin chloride IR then Mirabegron |
| MirabegronAlso: MyrbetriqMirabegron 25 mg tablet once daily for 2 weeks, followed by mirabegron 50 mg once daily for 4 weeks (Note: Placebo twice daily will be included with mirabegron once daily to match the three-time daily dosing of oxybutynin IR in the other intervention). | Drug | Mirabegron then Oxybutynin chloride IR, Oxybutynin chloride IR then Mirabegron |
Primary outcome
Change in cystometric bladder capacity during filing cystometry
Time frame: Week 6 and Week 12
The cystometric bladder capacity is the bladder volume (ml) at the end of the filling cystometrogram, when 'permission to void' is usually given.
13 secondary outcomes
Change in detrusor leak point pressure
Time frame: Week 6 and Week 12
Change in maximum detrusor pressure
Time frame: Week 6 and Week 12
Change in bladder compliance during filling cystometry
Time frame: Week 6 and Week 12
Change in post-void residual volume
Time frame: Week 6 and Week 12
Change on International Lower Urinary Tract Function Basic Spinal Cord Injury (SCI) Data Set
Time frame: Week 6 and Week 12
Change on Bowel Function Measures - International SCI Bowel Function Basic & Extended Data Sets
Time frame: Week 6 and Week 12
Change in California Verbal Learning Test - II (CVLT) scores
Time frame: Week 6 and Week 12
Change in Symbol Digit Modalities Test oral version (SDMT) scores
Time frame: Week 6 and Week 12
Wechsler Test of Adult Reading (WTAR) score
Time frame: Screening Visit
Change in Qualiveen scores
Time frame: Week 6 and Week 12
Change in SCI-QOL Bowel & Bladder Management Difficulties scores
Time frame: Week 6 and Week 12
Change in Subject Global Impression (SGI) of Change score
Time frame: Week 6 and Week 12
Change in Clinician Global Impression (CGI) of Change score
Time frame: Week 6 and Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
Todd A. Linsenmeyer, M.D. principal investigator
Kessler Institute for Rehabilitation
Steven C. Kirshblum, M.D. principal investigator
Kessler Institute for Rehabilitation
Trevor A. Dyson-Hudson, M.D. principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxybutynin Chloride IR and Mirabegron in people with Spinal Cord Injuries and Urinary Bladder, Neurogenic, run by Kessler Foundation 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 17 Dec 2019. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Todd A. Linsenmeyer, M.D. (973-243-6924, tlinsenmeyer@kessler-rehab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cystometric bladder capacity during filing cystometry (time frame: Week 6 and Week 12). 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 17 Dec 2019.