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
Purpose
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.
Conditions
- Neurogenic Detrusor Overactivity
- Spinal Cord Injuries
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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. 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 9 months prior to Screening. Treatment with BoNT/A was not started more than 3 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. 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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This first-in-human clinical study, performed in SCI participants with UI due to NDO and an inadequate response to current therapy, will evaluate the safety and tolerability of EG110A, and explore the potential doses for further clinical development. The present clinical study will also investigate the efficacy of EG110A via data collected in a bladder diary and via urodynamic assessments.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental EG110A (low dose) |
Patients who Received EG110A (low dose) |
|
|
Experimental EG110A (Middle Dose) |
Patients who Received EG110A (middle dose) |
|
|
Experimental EG110A (High Dose) |
Patients who Received EG110A (high dose) |
|
Recruiting Locations
UTHealth Houston / TIRR Memorial Hermann
Houston, Texas 77030
Houston, Texas 77030
Contact:
Argyrios Stampas, MD
Argyrios Stampas, MD
More Details
- Status
- Recruiting
- Sponsor
- EG 427
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 EG110A, and explore the potential doses for further clinical development. The present clinical study will also investigate the efficacy of EG110A via data collected in a bladder diary and via urodynamic assessments.