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

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Conditions

Neurogenic Detrusor OveractivitySpinal Cord Injuries

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-12
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06596291

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Participant has UI due to urodynamically-confirmed NDO for at least 3 months prior to Screening.
  3. 3. Participant has:
  4. 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.
  5. 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.
  1. 1. Participant has previous or current tumor or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of SCI.
  2. 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. 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.

Contacts and Locations

Study Contact

Sandrine Zourbas, Ph.D.
CONTACT
33 (0)6 25 62 28 02
szourbas@eg427.com
Cornelia Haag-Molkenteller, MD
CONTACT
Cornelia@eg427.com

Principal Investigator

Cornelia Haag-Molkenteller, MD
STUDY_DIRECTOR
EG 427

Study Locations (Sites)

Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
United States
Sidney Kimmel Medical College
Philadelphia, Pennsylvania, 19107
United States
TIRR Memorial Hermann
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: EG 427

  • Cornelia Haag-Molkenteller, MD, STUDY_DIRECTOR, EG 427

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12
Study Completion Date2027-03

Study Record Updates

Study Start Date2024-12
Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

  • Neurogenic Detrusor Overactivity
  • Spinal Cord Injuries