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

NCT06596291 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: EG110A-001-01HT94252510505_CDMRP
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

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

Spinal Cord Injuries; Neurogenic Detrusor Overactivity

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  Any participant who has a reported treatment-emergent adverse events (TEAEs)

  1 year

Secondary Outcomes (2)

• Urodynamic variables: changes at Weeks 12 and 52 compared to baseline

  1 year

• Bladder Diary measures: changes in 7 days' mean daily episodes at Weeks 12 and 52 compared to baseline

  1 year

Study Arms (3)

EG110A (low dose)

EXPERIMENTAL

Patients who Received EG110A (low dose)

Drug: EG110A

EG110A (Middle Dose)

EXPERIMENTAL

Patients who Received EG110A (middle dose)

Drug: EG110A

EG110A (High Dose)

EXPERIMENTAL

Patients who Received EG110A (high dose)

Drug: EG110A

Interventions

EG110A DRUG

Participants treated with EG110A

EG110A (High Dose); EG110A (Middle Dose); EG110A (low dose)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EG 427: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (4)

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

RECRUITING

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

WITHDRAWN

Sidney Kimmel Medical College

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

UTHealth Houston / TIRR Memorial Hermann

Houston, Texas, 77030, United States

RECRUITING

Related Links

• Learn more about the clinical study EG110A-001-01

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Cornelia Haag-Molkenteller, MD

  EG 427

  STUDY DIRECTOR

Central Study Contacts

Sandrine Zourbas, Ph.D.

CONTACT

33 (0)6 25 62 28 02; szourbas@eg427.com

Cornelia Haag-Molkenteller, MD

CONTACT

Cornelia@eg427.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This first-in-human clinical study, performed in SCI participants with 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.

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: January 8, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)