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
Cyllene Therapeutics · with Congressionally Directed Medical Research Programs · NCT06596291
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 1, Phase 2
- Target enrollment
- 16
- US sites recruiting
- 4
- Study start
- January 8, 2025
- Record last updated
- September 3, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: EG110A
Conditions: Neurogenic Detrusor Overactivity; Spinal Cord Injuries
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Main Inclusion Criteria
- 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 but no more than 12 years post injury.
- Participant has UI due to urodynamically-confirmed NDO for at least 3 months prior to Screening.
- Participant has:
- 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
- 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
- Participant has previous or current tumor or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of SCI.
- 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).
- 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.
Recruiting US locations
Rancho Los Amigos National Rehabilitation Center
Downey, CA 90242
Site contact: Evgeniy Kreydin, MD
Ohio State University
Columbus, OH 43212
Site contact: Iryna Crescenze, MD · 614-293-8155 · Iryna.Crescenze@osumc.edu
Sidney Kimmel Medical College
Philadelphia, PA 19107
Site contact: Patrick Shenot, MD
UTHealth Houston / TIRR Memorial Hermann
Houston, TX 77030
Site contact: Argyrios Stampas, MD
Study contacts (from the official record)
- Sandrine Zourbas, Ph.D. · 33 (0)6 25 62 28 02 · szourbas@eg427.com
- Cornelia Haag-Molkenteller, MD · Cornelia@eg427.com
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