Status:
RECRUITING
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
Lead Sponsor:
EG 427
Collaborating Sponsors:
Congressionally Directed Medical Research Programs
Conditions:
Neurogenic Detrusor Overactivity
Spinal Cord Injuries
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 wi...
Detailed Description
This first-in-human clinical study, performed in SCI participants with Urinary Incontinence (UI) due to NDO and an inadequate response to current therapy, will evaluate the safety and tolerability of ...
Eligibility Criteria
Inclusion
- Main
- 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.
- 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
- 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.
Key Trial Info
Start Date :
January 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06596291
Start Date
January 8 2025
End Date
April 1 2027
Last Update
July 18 2025
Active Locations (4)
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1
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
2
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
3
Sidney Kimmel Medical College
Philadelphia, Pennsylvania, United States, 19107
4
UTHealth Houston / TIRR Memorial Hermann
Houston, Texas, United States, 77030