Recruiting
Phase 1/2
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
Condition(s) studied
Neurogenic Detrusor OveractivitySpinal Cord Injuries
Investigational drug(s) / intervention(s)
EG110A: Participants treated with EG110A
Study 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
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 but no more than 12 years post injury.
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.
Primary outcome measure(s)
- Incidence of treatment-emergent adverse events (TEAEs) — 1 year
Any participant who has a reported treatment-emergent adverse events (TEAEs)
Trial sites (5)
| Facility | City | Region | Status |
| Rancho Los Amigos National Rehabilitation Center |
Downey |
California |
Recruiting |
| University of Michigan Rogel Cancer Center |
Ann Arbor |
Michigan |
Withdrawn |
| Ohio State University |
Columbus |
Ohio |
Recruiting |
| Sidney Kimmel Medical College |
Philadelphia |
Pennsylvania |
Recruiting |
| UTHealth Houston / TIRR Memorial Hermann |
Houston |
Texas |
Recruiting |
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