This is a first-in-human, Phase 1b/2a, open-label, dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of EG110A in male and female adult participants with Neurogenic Detrusor Overactivity (NDO)-related incontinence following Spinal Cord Injury (SCI), who have persistent incontinence after standard of care therapy and who perform Clear Intermittent Catheterization (CIC) on a regular basis.
This first-in-human clinical study, performed in SCI participants with Urinary Incontinence (UI) due to NDO and an inadequate response to current therapy, will evaluate the safety and tolerability of EG110A, and explore the potential doses for further clinical development. The present clinical study will also investigate the efficacy of EG110A via data collected in a bladder diary and via urodynamic assessments.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Participants treated with EG110A
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
RECRUITINGUniversity of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
WITHDRAWNSidney Kimmel Medical College
Philadelphia, Pennsylvania, United States
RECRUITINGUTHealth Houston / TIRR Memorial Hermann
Houston, Texas, United States
RECRUITINGIncidence of treatment-emergent adverse events (TEAEs)
Any participant who has a reported treatment-emergent adverse events (TEAEs)
Time frame: 1 year
Urodynamic variables: changes at Weeks 12 and 52 compared to baseline
Changes in urodynamic variables will be assessed at Weeks 12 and 52.
Time frame: 1 year
Bladder Diary measures: changes in 7 days' mean daily episodes at Weeks 12 and 52 compared to baseline
7 day bladder diary with recording of urinary incontinence episodes, daily catheterization rates, and volume per catheterization.
Time frame: 1 year
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