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Fesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI)

Primary Purpose

Autonomic Dysreflexia

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Fesoterodine
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autonomic Dysreflexia focused on measuring 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

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of British Columbia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Fesoterodine

Arm Description

Open-Label

Outcomes

Primary Outcome Measures

Number of participants that experience a decrease in severity of autonomic dysreflexia (AD) from baseline following 12-weeks of study medication.
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)

Secondary Outcome Measures

Number of participants that experience a decrease in the frequency of autonomic dysreflexia (AD) episodes from baseline following 12-weeks of study medication.
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.
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.
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.
An improvement from baseline in bowel stool outcomes as reported with the Bristol Stool Scale.
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..
An improvement from baseline in Cerebral Blood Flow (CBF) during Urodynamics Study (UDS)

Full Information

First Posted
January 27, 2016
Last Updated
September 5, 2019
Sponsor
University of British Columbia
Collaborators
Pfizer, International Collaboration on Repair Discoveries, Vancouver Coastal Health
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1. Study Identification

Unique Protocol Identification Number
NCT02676154
Brief Title
Fesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 25, 2016 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Pfizer, International Collaboration on Repair Discoveries, Vancouver Coastal Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Dysreflexia
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fesoterodine
Arm Type
Other
Arm Description
Open-Label
Intervention Type
Drug
Intervention Name(s)
Fesoterodine
Other Intervention Name(s)
Toviaz
Intervention Description
4mg, oral, once daily for 12 weeks; dose adjustments may be permitted.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
An improvement from baseline in bowel stool outcomes as reported with the Bristol Stool Scale.
Time Frame
12 weeks
Title
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
Title
An improvement from baseline in Cerebral Blood Flow (CBF) during Urodynamics Study (UDS)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Krassioukov, MD,PhD,FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
30467135
Citation
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.
Results Reference
derived

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Fesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI)

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