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

NCT ID: NCT02676154

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-25
• Study Completion Date: 2019-01-31

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).

Conditions

Autonomic Dysreflexia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fesoterodine

Open-Label

Group Type: OTHER

Fesoterodine

Intervention Type: DRUG

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

Interventions

Fesoterodine

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

Intervention Type: DRUG

Other Intervention Names

Toviaz

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

International Collaboration on Repair Discoveries

OTHER

Sponsor Role: collaborator

Vancouver Coastal Health

OTHER_GOV

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Andrei Krassioukov

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrei Krassioukov, MD,PhD,FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 30467135 (View on PubMed)

Other Identifiers

WI207218

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H15-02364

Identifier Type: -

Identifier Source: org_study_id