First-In-Human Phase 1b/2a Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adult Participants With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization
EG 427
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.
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Main Inclusion Criteria: 1. Participant has stable supra-sacral traumatic SCI with American Spinal Injury Association (ASIA) Impairment Scale grade A, B, C, D or E which occurred at least 12 months before Screening. 2. Participant has UI due to urodynamically-confirmed NDO for at least 3 months prior to Screening. 3. Participant has: 1. been treated for NDO for at least 3 months prior to Screening with an adequate course of oral pharmacotherapy(ies) and/or has had intolerable side-effects and/or exhibited an inadequate response in the opinion of the investigator and participant, i.e., at…
Interventions
- DrugEG110A
Participants treated with EG110A
Locations (4)
- Rancho Los Amigos National Rehabilitation CenterDowney, California
- University of Michigan Rogel Cancer CenterAnn Arbor, Michigan
- Sidney Kimmel Medical CollegePhiladelphia, Pennsylvania
- UTHealth Houston / TIRR Memorial HermannHouston, Texas