|Fesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI)
|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)
|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.
|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).
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
4mg, oral, once daily for 12 weeks; dose adjustments may be permitted.
Other Name: Toviaz
Intervention: Drug: Fesoterodine
|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.|
|January 31, 2019
|January 31, 2019 (Final data collection date for primary outcome measure)
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
|Sexes Eligible for Study:||All|
|18 Years to 60 Years (Adult)
|Contact information is only displayed when the study is recruiting subjects|
WI207218 ( Other Grant/Funding Number: Pfizer Canada Inc )
|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.|
|Andrei Krassioukov, University of British Columbia
|University of British Columbia
- International Collaboration On Repair Discoveries (ICORD)
- Vancouver Coastal Health
|Principal Investigator:||Andrei Krassioukov, MD,PhD,FRCPC||University of British Columbia|
|University of British Columbia