Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adults With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization
Start Date
1/8/2025
Completion Date
6/1/2027
Summary
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.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
EG110A
Conditions
Locations
Rancho Los Amigos National Rehabilitation Center
Downey, California 90242
United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United States
Sidney Kimmel Medical College
Philadelphia, Pennsylvania 19107
United States
UTHealth Houston / TIRR Memorial Hermann
Houston, Texas 77030
United States