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

Launched by EG 427 · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called EG110A for adults who experience incontinence due to a condition known as Neurogenic Detrusor Overactivity (NDO), which often happens after spinal cord injuries. The study is looking for individuals who have been struggling with incontinence despite trying standard treatments and who regularly use a method called Clean Intermittent Catheterization (CIC) to help empty their bladder. Participants will receive multiple injections of EG110A directly into the bladder and will be monitored for safety and effectiveness.

To be eligible for this trial, participants must be adults aged 18 and older with stable spinal cord injuries that have lasted for at least a year. They should also have had ongoing issues with incontinence for at least three months, despite receiving previous treatments. Specifically, those who have not responded well to other therapies or who prefer not to pursue surgical options may be a good fit. The trial is currently recruiting participants, and those who join can expect close medical supervision and support throughout the study. This is an important step toward finding new options for people dealing with incontinence after spinal cord injuries.

Gender

ALL

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.