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

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ClinicalTrials.gov Identifier: NCT02676154
Recruitment Status : Completed
First Posted : February 8, 2016
Last Update Posted : September 9, 2019
Sponsor:
Collaborators:
Pfizer
International Collaboration On Repair Discoveries (ICORD)
Vancouver Coastal Health
Information provided by (Responsible Party):
Andrei Krassioukov, University of British Columbia

Tracking Information
First Submitted Date  ICMJE January 27, 2016
First Posted Date  ICMJE February 8, 2016
Last Update Posted Date September 9, 2019
Actual Study Start Date  ICMJE February 25, 2016
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
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 ]
Change History Complete list of historical versions of study NCT02676154 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • 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 urodynamic studies (UDS) parameters of bladder volume and pressure on the detrusor muscle.. [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI)
Official Title  ICMJE 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)
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autonomic Dysreflexia
Intervention  ICMJE Drug: Fesoterodine
4mg, oral, once daily for 12 weeks; dose adjustments may be permitted.
Other Name: Toviaz
Study Arms  ICMJE Fesoterodine
Open-Label
Intervention: Drug: Fesoterodine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2019)
15
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2016)
20
Actual Study Completion Date  ICMJE January 31, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02676154
Other Study ID Numbers  ICMJE H15-02364
WI207218 ( Other Grant/Funding Number: Pfizer Canada Inc )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party Andrei Krassioukov, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE
  • Pfizer
  • International Collaboration On Repair Discoveries (ICORD)
  • Vancouver Coastal Health
Investigators  ICMJE
Principal Investigator: Andrei Krassioukov, MD,PhD,FRCPC University of British Columbia
PRS Account University of British Columbia
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP