Testing EG110A injections for bladder control in spinal cord injury patients
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
This study is testing if EG110A injections can help people with spinal cord injuries who have trouble controlling their bladder feel more comfortable and manage their incontinence better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Eg 427 Industry-sponsored |
| Locations | 4 sites (Downey, California and 3 other locations) |
| Trial ID | NCT06596291 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, Phase 1b/2a, open-label, dose-escalation study evaluating the safety and tolerability of EG110A administered through multiple intradetrusor injections in adults with Neurogenic Detrusor Overactivity-related incontinence following spinal cord injury. Participants must have persistent incontinence despite standard therapies and regularly perform clean intermittent catheterization. The study will also assess the efficacy of EG110A using bladder diaries and urodynamic assessments to gather comprehensive data on its impact.
Who should consider this trial
Good fit: Ideal candidates are adults with stable spinal cord injuries and persistent urinary incontinence due to neurogenic detrusor overactivity after inadequate response to standard therapies.
Not a fit: Patients who have not experienced urinary incontinence or those who have not undergone prior treatments for neurogenic detrusor overactivity may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve bladder control and quality of life for patients with neurogenic detrusor overactivity.
How similar studies have performed: While this approach is novel, similar studies targeting neurogenic bladder conditions have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 least 8 UI episodes in a week despite consistent use of the therapy. Participant does not wish to proceed to BoNT/A treatment, and their next step would be surgical intervention.
OR
2. had an inadequate response to BoNT/A treatment in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week, and the last BoNT/A treatment for their NDO was at least 6 months prior to screening. Treatment with BoNT/A was not started more than 7 years ago, and their next step would be surgical intervention.
Main Exclusion Criteria:
1. Participant has previous or current tumor or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of SCI.
2. Participant with active oral or genital herpes lesion. If the participant has an active oral or genital herpes infection this needs to be treated and healed first. The participant may be rescreened once the lesion has fully healed (at least 4 weeks after the lesion has healed).
3. 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.
Where this trial is running
Downey, California and 3 other locations
- Rancho Los Amigos National Rehabilitation Center — Downey, California, United States (Recruiting)
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States (Withdrawn)
- Sidney Kimmel Medical College — Philadelphia, Pennsylvania, United States (Recruiting)
- UTHealth Houston / TIRR Memorial Hermann — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Sandrine Zourbas, Ph.D.
- Email: szourbas@eg427.com
- Phone: 33 (0)6 25 62 28 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.