NCT06596291 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
| NCT ID | NCT06596291 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | EG 427 |
| Condition | Neurogenic Detrusor Overactivity |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2025-01-08 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2025-01-08 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Cornelia Haag-Molkenteller, MD
STUDY DIRECTOR
EG 427
Frequently Asked Questions
Who can join the NCT06596291 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Neurogenic Detrusor Overactivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06596291 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06596291 currently recruiting?
Yes, NCT06596291 is actively recruiting participants. Contact the research team at szourbas@eg427.com for enrollment information.
Where is the NCT06596291 trial being conducted?
This trial is being conducted at Downey, United States, Ann Arbor, United States, Philadelphia, United States, Houston, United States.
Who is sponsoring the NCT06596291 clinical trial?
NCT06596291 is sponsored by EG 427. The principal investigator is Cornelia Haag-Molkenteller, MD at EG 427. The trial plans to enroll 16 participants.