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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

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.

Condition or disease Intervention/treatment Phase
Autonomic Dysreflexia Drug: Fesoterodine Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 25, 2016
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Fesoterodine
Open-Label
Drug: Fesoterodine
4mg, oral, once daily for 12 weeks; dose adjustments may be permitted.
Other Name: Toviaz




Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. An improvement from baseline in bowel stool outcomes as reported with the Bristol Stool Scale. [ Time Frame: 12 weeks ]
  6. 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 ]
  7. An improvement from baseline in Cerebral Blood Flow (CBF) during Urodynamics Study (UDS) [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676154


Locations
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Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Pfizer
International Collaboration On Repair Discoveries (ICORD)
Vancouver Coastal Health
Investigators
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Principal Investigator: Andrei Krassioukov, MD,PhD,FRCPC University of British Columbia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrei Krassioukov, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02676154     History of Changes
Other Study ID Numbers: H15-02364
WI207218 ( Other Grant/Funding Number: Pfizer Canada Inc )
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
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.
Keywords provided by Andrei Krassioukov, University of British Columbia:
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
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Autonomic Dysreflexia
Wounds and Injuries
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Autonomic Nervous System Diseases
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents