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Procedure

EG110A for Neurogenic Detrusor Overactivity

Phase 1 & 2
Recruiting
Research Sponsored by EG 427
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
Participant had cancer therapy or radiotherapy ≤ 4 weeks prior to Screening and has toxicities/AEs attributable to previously administered cancer therapies that have not resolved or stabilized.
Participant has previous or current tumor or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of SCI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment for people with bladder control issues caused by spinal cord injuries. Participants will receive injections of EG110A directly into the bladder to see if it helps reduce incontinence

Who is the study for?
This trial is for adults with bladder control issues due to nerve damage from a spinal cord injury, who still have incontinence despite standard treatments and regularly use a catheter. Participants must be stable post-injury and able to attend all study visits.
What is being tested?
The study tests multiple doses of EG110A, given via bladder injections, to see if it can help with incontinence caused by neurogenic detrusor overactivity following spinal cord injury. It's an early-phase trial to find the right dose.
What are the potential side effects?
As this is a first-in-human study for EG110A, specific side effects are unknown but may include local reactions at the injection site or urinary tract infections due to the nature of intradetrusor injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My spinal cord injury is stable and happened over a year ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I had cancer treatment within the last 4 weeks and still have side effects.
Select...
I have a tumor or cancer affecting my spine or have another cause for spinal cord injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of treatment-emergent adverse events (TEAEs)
Secondary study objectives
Bladder Diary measures: changes in 7 days' mean daily episodes at Weeks 12 and 52 compared to baseline
Urodynamic variables: changes at Weeks 12 and 52 compared to baseline

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: EG110A (low dose)Experimental Treatment1 Intervention
Patients who Received EG110A (low dose)
Group II: EG110A (Middle Dose)Experimental Treatment1 Intervention
Patients who Received EG110A (middle dose)
Group III: EG110A (High Dose)Experimental Treatment1 Intervention
Patients who Received EG110A (high dose)

Find a Location

Who is running the clinical trial?

EG 427Lead Sponsor
Cornelia Haag-Molkenteller, MDStudy DirectorEG 427
~11 spots leftby Mar 2027
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