Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy

NCT07227285 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: EG110A-001-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of this study is to continue following participants who have received EG110A during five years to know how it is tolerated in humans, any side-effects it may cause and what might be an effective dose over five years. All participants who have received at least one dose/injection of EG110A in a previous clinical study of EG110A will be asked to roll-over to this long-term follow-up study upon either early discontinuation from, or completion of, that study.

Conditions

Urinary Bladder, Overactive; Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment emergent serious adverse events (TESAEs)

  Any participant who has a reported treatment emergent serious adverse event (TESAE)

  5 years

• Incidence of treatment emergent adverse events (TEAEs) including treatment emergent averse events of special interest (TEAESIs)

  Any participant who has a reported emergent adverse event (TEAE) including treatment emergent averse events of special interest (TEAESIs)

  5 years

Secondary Outcomes (2)

• Patient-reported outcome (PRO) questionnaire

  5 years

• Duration of response to EG110A

  5 years

Study Arms (1)

Patients who received EG110A in a clinical study, regardless of dose

EXPERIMENTAL

Other: Urodynamics; Drug: EG110A; Other: Patient-reported Outcome

Interventions

Urodynamics OTHER

standardized local evaluation of urodynamic parameters

Patients who received EG110A in a clinical study, regardless of dose

EG110A DRUG

Patients already treated with EG110A

Patients who received EG110A in a clinical study, regardless of dose

Patient-reported Outcome OTHER

assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms

Patients who received EG110A in a clinical study, regardless of 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:

• \- All participants who received at least one dose/injection of EG110A in Study EG110A-001-01 and have prematurely discontinued or completed that study.

You may not qualify if:

• Participant plans to participate in another investigational gene therapy study
• Participant has an uncontrolled intercurrent illness, any disorder, or current substance abuse that would limit compliance with study requirements in the opinion of the investigator

Sponsors & Collaborators

• EG 427: lead

Study Sites (4)

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

Location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Sidney Kimmel Medical College

Philadelphia, Pennsylvania, 19107, United States

Location

UTHealth Houston / TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Spinal Cord Injuries

Interventions

Urodynamics; Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Cornelia Haag-Molkenteller, MD

  EG 427

  STUDY DIRECTOR

Central Study Contacts

Sandrine Zourbas, Ph.D.

CONTACT

33 (0)625622802; szourbas@eg427.com

Cornelia Haag-Molkenteller, MD

CONTACT

Cornelia@eg427.com

Study Design

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

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: November 12, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)