Actively Recruiting
First-In-Human Phase 1b/2a Dose Escalation Study of EG110A by Intradetrusor Injections in Adults with Neurogenic Detrusor Overactivity-Related Incontinence Following Spinal Cord Injury
Led by EG 427 · Updated on 2026-02-05
16
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
E
EG 427
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying EG110A in adults with Neurogenic Detrusor Overactivity (NDO) related urinary incontinence caused by spinal cord injury (SCI). This first-in-human Phase 1b/2a trial aims to evaluate the safety and tolerability of EG110A and explore appropriate doses for future studies. Participants have persistent incontinence after standard care and perform Clean Intermittent Catheterization (CIC) regularly. The study involves a single course of multiple intradetrusor injections of EG110A at low, middle, or high doses. Participants receive one of these doses without randomization or placebo control. The trial includes dose escalation to find the best dose. It collects data through bladder diaries and urodynamic assessments to investigate how EG110A affects bladder function. Participants will be monitored for up to one year, including safety checks for treatment-emergent adverse events (TEAEs). Changes in bladder function are measured at 12 and 52 weeks compared to baseline. The study requires regular assessments, including urodynamic tests and bladder diaries, to track treatment effects and safety throughout the follow-up period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Stable supra-sacral traumatic spinal cord injury (SCI) at least 12 months before screening
- Urinary incontinence due to urodynamically confirmed neurogenic detrusor overactivity for at least 3 months prior to screening
- Treated for neurogenic detrusor overactivity for at least 3 months with adequate oral therapy but with at least 8 urinary incontinence episodes per week or intolerable side effects
- Alternatively, inadequate response to botulinum toxin A (BoNT/A) treatment with at least 8 urinary incontinence episodes per week and last BoNT/A treatment at least 6 months before screening
- Regular performance of clean intermittent catheterization
You will not qualify if you...
- Previous or current tumor or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of spinal cord injury
- Active oral or genital herpes infection unless fully healed for at least 4 weeks before rescreening
- Cancer therapy or radiotherapy within 4 weeks prior to screening with unresolved toxicities or adverse events
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants receive EG110A by intradetrusor injections at one of three dose levels to evaluate safety, tolerability, and potential efficacy.
Visits occur at baseline and follow-ups including assessments at Weeks 12 and 52
Trial Site Locations
Total: 4 locations
1
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
Actively Recruiting
2
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Withdrawn
3
Sidney Kimmel Medical College
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
4
UTHealth Houston / TIRR Memorial Hermann
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sandrine Zourbas, Ph.D.
C
Cornelia Haag-Molkenteller, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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