Autonomic DysreflexiaPhase 2NCT02676154
Fesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI)
A Phase 2 study testing Fesoterodine in people with Autonomic Dysreflexia, run by University of British Columbia at 1 site in Canada.
Trial summary
This study will be investigating the effects of fesoterodine on autonomic dysreflexia (AD) in patients with spinal cord injuries (SCI). The goal of the study is to examine the effect of increasing daily use of fesoterodine on episodes of high blood pressure triggered by urinary bladder contractions. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Autonomic Dysreflexia
- What is being tested?
- Fesoterodine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 25 Feb 2016to 31 Jan 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
The inclusion criteria include, but are not limited to, the following:
- Male or female, 18 - 60 years of age
- Chronic traumatic SCI at or above T6 spinal segment and >1 year post injury
- Documented presence of AD and NDO during UDS
- Hand function sufficient to perform CIC or a committed caregiver to provide CIC for management of urinary bladder drainage
- Patients must have documented two weeks of bladder and bowel history prior to their baseline visit
- Willing and able to comply with all clinic visits and study-related procedures
- Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
- Women of childbearing potential must not be intended to become pregnant, currently pregnant, or lactating. The following conditions apply:
- Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit. During the trial, all women of childbearing potential will undergo urine pregnancy tests at their monthly clinic visits as outlined in the schedule of events.
- Women of childbearign potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.
- Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment
- Must Provide Informed Consent
The exclusion criteria include, but are not limited to, the following:
- Presence of severe acute medical issue that in the investigator's judgement would adversely affect the patient's participation in the study
- A hypersensitivity to tolterodine (available as Detrol, Detrol LA), soya, peanuts, or lactose
- Recent treatment with intravesical OnabotulinumtoxinA (within 9 months of the baseline visit)
- Recent treatment with other anticholinergics medications (within 3 weeks of the baseline visit)
- Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the patient to participate in this study
- Patient is a member of the investigational team or his /her immediate family
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: A Phase II, Open-Label Exploratory Study Investigating the Efficacy of Toviaz for Treatment of Adult Patients With Spinal Cord Injury With Neurogenic Detrusor Overactivity for Amelioration of Autonomic Dysreflexia(PIIR-AK-TOVIAZ-AD)
This study will be investigating the effects of fesoterodine on autonomic dysreflexia (AD) in patients with spinal cord injuries (SCI). The goal of the study is to examine the effect of increasing daily use of fesoterodine on episodes of high blood pressure triggered by urinary bladder contractions.
Read the detailed description
This is a Phase 2, open-label exploratory study investigating the efficacy of fesoterodine for treatment of adult patients with spinal cord injuries (SCI) with autonomic dysreflexia (AD) triggered by neurogenic detrusor overactivity (NDO).
- Conditions
- Autonomic Dysreflexia
- Being tested
- Fesoterodine
- Keywords
- Episodic Hypertension, Spinal Cord Injury, Traumatic Spinal Cord Injury, Blood Pressure, Fesoterodine, Neurogenic Detrusor Overactivity, Autonomic Dysreflexia, Urodynamic Studies, 24 Hour Ambulatory Blood Pressure Monitoring, Cerebral Blood Flow
- Medical subject headings
- Autonomic Dysreflexia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FesoterodineDrug
Also called Toviaz
4mg, oral, once daily for 12 weeks; dose adjustments may be permitted.
| Study group | Role | What they receive |
|---|---|---|
| Fesoterodine | Other | Open-Label Receives: Drug: Fesoterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that experience a decrease in severity of autonomic dysreflexia (AD) from baseline following 12-weeks of study medication.
Measured: 12 weeks
Number of participants that experience a decrease in the severity of spontaneously occurring episode of Autonomic Dysreflexia (AD) during the 24 hour Ambulatory Blood Pressure Monitoring (24hr ABPM)
Measured: 12 weeks
Secondary outcomes (7)
Number of participants that experience a decrease in the frequency of autonomic dysreflexia (AD) episodes from baseline following 12-weeks of study medication.
Measured: 12 weeks
Number of participants that experience an improvement from baseline of self-reported severity and frequency of AD as reported with the Autonomic Dysreflexia Health Related-Quality of Life (AD HR-QoL) questionnaire and reflected by a decrease in score.
Measured: 12 weeks
An improvement from baseline of self-reported bladder incontinence as reported with the Incontinence Quality of Life (I-QoL) questionnaire and reflected with an increase in score.
Measured: 12 weeks
An improvement from baseline of cognitive function as evaluated with the Montreal Cognitive Assessment scale (MoCA) and reflected with a total score at or greater than 26.
Measured: 12 weeks
An improvement from baseline in bowel stool outcomes as reported with the Bristol Stool Scale.
Measured: 12 weeks
An Improvement from baseline in the ability of the bladder to stretch in response to filling of the bladder as indicated by Urodynamics Study (UDS) parameters of bladder volume and pressure on the detrusor muscle..
Measured: 12 weeks
An improvement from baseline in Cerebral Blood Flow (CBF) during Urodynamics Study (UDS)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study start25 Feb 2016
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autonomic DysreflexiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, International Collaboration on Repair Discoveries, Vancouver Coastal Health
- Responsible party
- Principal investigator, Andrei Krassioukov, University of British Columbia
- Investigators
- Andrei Krassioukov, MD,PhD,FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676154
- Sponsor's protocol ID
- H15-02364
- Other IDs
- WI207218
- Status last verified
- Sep 2019
- First submitted
- 27 Jan 2016
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data collected during the study will be used by the investigator to communicate results of the study to the research community. Data will mostly be communicated as a pooled data set; in the event that individual participant data is communicated, it will be represented with the unique study identifier which does not identify the individual participant.
Publications
Walter M, Ramirez AL, Lee AH, Rapoport D, Kavanagh A, Krassioukov AV. Protocol for a phase II, open-label exploratory study investigating the efficacy of fesoterodine for treatment of adult patients with spinal cord injury suffering from neurogenic detrusor overactivity for amelioration of autonomic dysreflexia. BMJ Open. 2018 Nov 21;8(11):e024084. doi: 10.1136/bmjopen-2018-024084.
PubMed 30467135
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label Exploratory Study Investigating the Efficacy of Toviaz for Treatment of Adult Patients With Spinal Cord Injury With Neurogenic Detrusor Overactivity for Amelioration of Autonomic Dysreflexia(PIIR-AK-TOVIAZ-AD)
- ClinicalTrials.gov ID
- NCT02676154
- Acronym / sponsor ID
- H15-02364
- Conditions
- Autonomic Dysreflexia
- Keywords
- Episodic Hypertension, Spinal Cord Injury, Traumatic Spinal Cord Injury, Blood Pressure, Fesoterodine, Neurogenic Detrusor Overactivity, Autonomic Dysreflexia, Urodynamic Studies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Pfizer, International Collaboration on Repair Discoveries, Vancouver Coastal Health
- Study start
- 25 Feb 2016 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 8 Feb 2016 (estimated)
- 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.
This study will be investigating the effects of fesoterodine on autonomic dysreflexia (AD) in patients with spinal cord injuries (SCI). The goal of the study is to examine the effect of increasing daily use of fesoterodine on episodes of high blood pressure triggered by urinary bladder contractions.
Detailed description
This is a Phase 2, open-label exploratory study investigating the efficacy of fesoterodine for treatment of adult patients with spinal cord injuries (SCI) with autonomic dysreflexia (AD) triggered by neurogenic detrusor overactivity (NDO).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fesoterodine | Other | Drug: FesoterodineOpen-Label |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| FesoterodineAlso: Toviaz4mg, oral, once daily for 12 weeks; dose adjustments may be permitted. | Drug | Fesoterodine |
Primary outcome
Number of participants that experience a decrease in severity of autonomic dysreflexia (AD) from baseline following 12-weeks of study medication.
Time frame: 12 weeks
Number of participants that experience a decrease in the severity of spontaneously occurring episode of Autonomic Dysreflexia (AD) during the 24 hour Ambulatory Blood Pressure Monitoring (24hr ABPM)
Time frame: 12 weeks
7 secondary outcomes
Number of participants that experience a decrease in the frequency of autonomic dysreflexia (AD) episodes from baseline following 12-weeks of study medication.
Time frame: 12 weeks
Number of participants that experience an improvement from baseline of self-reported severity and frequency of AD as reported with the Autonomic Dysreflexia Health Related-Quality of Life (AD HR-QoL) questionnaire and reflected by a decrease in score.
Time frame: 12 weeks
An improvement from baseline of self-reported bladder incontinence as reported with the Incontinence Quality of Life (I-QoL) questionnaire and reflected with an increase in score.
Time frame: 12 weeks
An improvement from baseline of cognitive function as evaluated with the Montreal Cognitive Assessment scale (MoCA) and reflected with a total score at or greater than 26.
Time frame: 12 weeks
An improvement from baseline in bowel stool outcomes as reported with the Bristol Stool Scale.
Time frame: 12 weeks
An Improvement from baseline in the ability of the bladder to stretch in response to filling of the bladder as indicated by Urodynamics Study (UDS) parameters of bladder volume and pressure on the detrusor muscle..
Time frame: 12 weeks
An improvement from baseline in Cerebral Blood Flow (CBF) during Urodynamics Study (UDS)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Derived from this study: PubMed 30467135Walter M, Ramirez AL, Lee AH, Rapoport D, Kavanagh A, Krassioukov AV. Protocol for a phase II, open-label exploratory study investigating the efficacy of fesoterodine for treatment of adult patients with spinal cord injury suffering from neurogenic detrusor overactivity for amelioration of autonomic dysreflexia. BMJ Open. 2018 Nov 21;8(11):e024084. doi: 10.1136/bmjopen-2018-024084.
- Individual participant dataSharing planned: No. Data collected during the study will be used by the investigator to communicate results of the study to the research community. Data will mostly be communicated as a pooled data set; in the event that individual participant data is communicated, it will be represented with the unique study identifier which does not identify the individual participant.
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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.
Andrei Krassioukov, MD,PhD,FRCPC principal investigator
University of British Columbia
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 Fesoterodine in people with Autonomic Dysreflexia, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Sep 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 Canada. 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?
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?
Number of participants that experience a decrease in severity of autonomic dysreflexia (AD) from baseline following 12-weeks of study medication. (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT02676154, which also lists 1 linked publication.
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 9 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.