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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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)

Conditions
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Autonomic Dysreflexia

Intervention / Treatment
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* Drug: Fesoterodine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fesoterodine<br>Open-Label | Drug: Fesoterodine<br>* 4mg, oral, once daily for 12 weeks; dose adjustments may be permitted.<br>* Other names: Toviaz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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.. |  | 12 weeks | 
| An improvement from baseline in Cerebral Blood Flow (CBF) during Urodynamics Study (UDS) |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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