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Recruiting NCT06596291

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

Phase I / Phase II Interventional Neurogenic Detrusor Overactivity Spinal Cord Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EG110A.
Who it may be relevant to
Registry conditions: Neurogenic Detrusor Overactivity, Spinal Cord Injuries. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

First-In-Human Phase 1b/2a Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adult Participants With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization

Overview

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.

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.

Interventions

  • Drug EG110A
    Participants treated with EG110A

Primary outcome measures

  • Incidence of treatment-emergent adverse events (TEAEs) [Time frame: 1 year]
Secondary outcome measures (2)
  • Urodynamic variables: changes at Weeks 12 and 52 compared to baseline [Time frame: 1 year]
  • Bladder Diary measures: changes in 7 days' mean daily episodes at Weeks 12 and 52 compared to baseline [Time frame: 1 year]

Eligibility criteria

Main 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.
  • 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 Criteria:

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Rancho Los Amigos National Rehabilitation Center — Downey
  • University of Michigan Rogel Cancer Center — Ann Arbor
  • Sidney Kimmel Medical College — Philadelphia
  • UTHealth Houston / TIRR Memorial Hermann — Houston

Identifiers

NCT: NCT06596291 · EG110A-001-01 · HT94252510505_CDMRP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗