NCT02676154

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

February 25, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

2.9 years

First QC Date

January 27, 2016

Last Update Submit

September 5, 2019

Conditions

Autonomic Dysreflexia

Keywords

Episodic HypertensionSpinal Cord InjuryTraumatic Spinal Cord InjuryBlood PressureFesoterodineNeurogenic Detrusor OveractivityAutonomic DysreflexiaUrodynamic Studies24 Hour Ambulatory Blood Pressure MonitoringCerebral Blood Flow

Outcome Measures

Primary Outcomes (2)

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

    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)

    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.

    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.

    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.

    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.

    12 weeks

  • An improvement from baseline in bowel stool outcomes as reported with the Bristol Stool Scale.

    12 weeks

  • +2 more secondary outcomes

Study Arms (1)

Fesoterodine

OTHER

Open-Label

Drug: Fesoterodine

Interventions

FesoterodineDRUG

4mg, oral, once daily for 12 weeks; dose adjustments may be permitted.

Also known as: Toviaz
Fesoterodine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 30467135DERIVED

MeSH Terms

Conditions

Autonomic DysreflexiaSpinal Cord Injuries

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemSpinal Cord DiseasesCentral Nervous System DiseasesWounds and Injuries

Study Officials

  • Andrei Krassioukov, MD,PhD,FRCPC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 8, 2016

Study Start

February 25, 2016

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

September 9, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

CA(1)