Recruiting
Phase 1
Phase 2

EG110A

Sponsor:

Cyllene Therapeutics

Code:

NCT06596291

Conditions

Neurogenic Detrusor Overactivity

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

EG110A

Study Details

Brief summary:

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

Study ID

NCT06596291

Start date

Jan 8, 2025

Status verified date

Sep, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

16 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EG110A (low dose)

Patients who Received EG110A (low dose)

experimental: EG110A (Middle Dose)

Patients who Received EG110A (middle dose)

experimental: EG110A (Low-low Dose)

Patients who Received EG110A (low-low dose)

Interventions

EG110A

Participants treated with EG110A

Primary outcome measure

  • Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Cornelia Haag-Molkenteller, MD

Cornelia@eg427.com

Locations

Rancho Los Amigos National Rehabilitation Center

Recruiting

Downey, California, United States, 90242

Ohio State University

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Sidney Kimmel Medical College

Recruiting

Philadelphia, Pennsylvania, United States, 19107

UTHealth Houston / TIRR Memorial Hermann

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Cyllene Therapeutics

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Cyllene Therapeutics on 2026-09-03.