Actively Recruiting
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
Led by EG 427 · Updated on 2026-02-05
16
Participants Needed
4
Research Sites
124 weeks
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
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.
CONDITIONS
Official 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...
- Stable supra-sacral traumatic spinal cord injury (SCI) with ASIA Impairment Scale grade A, B, C, D, or E occurring 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 NDO for at least 3 months with oral medications and/or had intolerable side effects or inadequate response, defined as at least 8 urinary incontinence episodes per week despite therapy
- Participant does not wish to proceed to botulinum toxin A treatment and would consider surgical intervention next
- Or had inadequate response to botulinum toxin A treatment with at least 8 urinary incontinence episodes per week, and last treatment was at least 6 months prior to screening, with treatment not started more than 7 years ago
- Regularly performs Clean Intermittent Catheterization (CIC)
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 lesions; participant may be rescreened after lesions have fully healed (at least 4 weeks post-healing)
- Received cancer therapy or radiotherapy within 4 weeks prior to screening and has unresolved or unstable toxicities or adverse events related to prior cancer treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
C
Cornelia Haag-Molkenteller, MD
CONTACT
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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