Testing EG110A injections for bladder control in spinal cord injury patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, Phase 1b/2a, open-label, dose-escalation study evaluating the safety and tolerability of EG110A administered through multiple intradetrusor injections in adults with Neurogenic Detrusor Overactivity-related incontinence following spinal cord injury. Participants must have persistent incontinence despite standard therapies and regularly perform clean intermittent catheterization. The study will also assess the efficacy of EG110A using bladder diaries and urodynamic assessments to gather comprehensive data on its impact.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rancho Los Amigos National Rehabilitation Center
  Downey, California, United States Recruiting
• Ohio State University
  Columbus, Ohio, United States Recruiting
• Sidney Kimmel Medical College
  Philadelphia, Pennsylvania, United States Recruiting
• UTHealth Houston / TIRR Memorial Hermann
  Houston, Texas, United States Recruiting
• University of Michigan Rogel Cancer Center
  Ann Arbor, Michigan, United States Withdrawn

Study contacts

• Study coordinator: Sandrine Zourbas, Ph.D.
• Email: szourbas@eg427.com
• Phone: 33 (0)6 25 62 28 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.